A PROSPECTIVE STUDY ASSESSING

SATISFACTION AND QUALITY OF LIFE BY

PATIENT REPORTED OUTCOMES AFTER
URETHROPLASTY SURGERY DONE AT MYH
HOSPITAL,INDORE

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 CONTENTS
1. INTRODUCTION
2. AIM & OBJECTIVES
3. REVIEW OF LITRATURE
4. MATERIAL & METHODS
5. RESULT & OBSERVATIONS
6. DISCUSSION
7. SUMMMARY & CONCLUSION
8. REFRENCES
9. ANNEXURES
- PROFORMA
- CONSENT FORM
- PATIENT INFORMATION DOCUMENT
- MASTER CHART

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 LIST OF ABBREVATIONS
 AUASS :- American Urological Association Symptom Score

 BPH :- Benign Prostatic Hyperplasia

 DUS :- Distal Urethral Sphincter

 EjF :- Ejaculatory Function

 EQ-5D :- EuroQol – 5 Dimensional

 EQVAS :- EuroQoL Visual Analoge Scale

 FR :- Flow Rates

 HRQOL :- Health Related Quality Of Life

 ICIQMLUTS :-International Consultation On Incontinence

Questionnaire Male Lower Urinary Tract Symptoms

 ICI-Q-SF :- International Consultation Committee On

Incontinence Questionnaire Male Short Form

 IIEF :- International Index Of Erectile Function

 IPSS :- International Prostate Symptom Score

 LUTS :- Lower Urinary Tract Symptoms

 PFUDD :- Pelvic Fracture-Urethral Distraction Defect

 PROM :- Patient Related Outcomes Measure

 PUS :- Proximal Urethral Sphincter

 SPC :- Suprapubic Catheter

 USSPROM :-Urethral Stricture Surgery Patient Related Outcome

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 USD :- Urethral Sphincter Disease

 UTI :- Urinary Tract Infection

4
INTRODUCTION

5
 INTRODUCTION

As there is an increasingly widespread use of urethroplasty for

urethral stricture treatment,1 the potential complications of the surgery

need to be better understood in order to reduce their probability of

occurrence and enable the specialist to provide the right information

during counseling.

Urethral stricture disease occurs in 0.6% of the general population,

and despite known risk factors (including trauma, endoscopic

interventions, inflammation, and infection), the most common etiology is

idiopathic

Urethral stricture disease causes obstructive and irritative voiding

symptoms however, hematuria, recurrent urinary tract infection, inability

to catheterize at the time of unrelated surgeries, or bladder stone also

occur that might have an impact on the patient’s quality of life. Different

techniques of urethroplasty in the treatment of urethral stricture disease

are well described2-4. Although international accepted guidelines about

the treatment are lacking, some recommendations have been made 5-7 on

timely basis. The primary outcome parameter of papers assessing the

different techniques of urethroplasty has been stricture recurrence. The

6
need for further instrumentation or reoperation is considered for stricture

recurrence by the majority of urologists8. Since urethroplasty is

performed on the penis and/or in the perineum, it might have an impact

on the patient’s erectile function9. Postoperative sequestration of urine in

the urethra and diminished tone of the perineal muscles can lead to (an

increase of) postvoid dribbling9. Posterior urethroplasty is considered to

jeopardize the function of the external urethral sphincter and might lead

to urinary incontinence.

All these possible alterations in urinary and sexual function might

have an impact on the patient’s satisfaction with the procedure. It has

previously been reported that patient’s satisfaction is not always the

same as what the surgeon defines as success10. This study mainly

focusses on the impact of urethroplasty on the patient’s short-term

functional outcome and the satisfaction with the procedure. Successful

treatment of urethral stricture in males is known to dramatically improve

urinary function, sexual health, and overall quality of life.

Urethral strictures are a high complexity disease that impacts on

quality of life (QoL) with an increasing reported incidence in elderly

population11. The aim of any intervention is to restore patient’s normal

pattern of voiding while maintaining a good QoL12. Urethroplasty is

considered the gold standard for the management of urethral stricture

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disease with excellent and durable successful reported rates13,14. It has

already been shown that urethroplasty is the most cost-effectiveness

strategy compared to minimally invasive procedures in the treatment of

urethral stricture disease15,16.

Open surgical urethral reconstruction is the gold standard treatment

for urethral stricture disease. Despite a greater understanding of how to

manage urethral strictures, the many advancements in surgical technique,

and reported surgical success following urethral reconstruction17, extreme

variations exist among urologic reconstructive surgeons regarding

appropriate postoperative follow-up18. Currently there is no standardized

surveillance protocol after open urethral reconstruction, however, most

surgeons will use a combination of questionnaires, noninvasive testing

such as uroflowmetry (UF), and invasive procedures such as retrograde

urethrogram (RUG) and cystoscopy. While the burden to the patient who

is compliant with these protocols can be great (i.e., stress, physical

discomfort, loss of work and transportation costs), the usefulness of these

protocols to the patient has been openly questioned19.

A major barrier in developing standardized protocols for urethral

monitoring after urethroplasty is that there is also no consensus regarding

the definition of urethroplasty success or failure20-22. Such significant

gaps regarding the management of urethral stricture disease after open

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urethral reconstruction limits our ability to engage in meaningful

comparison of surgical outcomes, assessing patient quality of life metrics,

and ultimately the advancement of the field.

In a healthcare system that is increasingly driven to deliver cost-

effective medicine with a minimally invasive approach while maximizing

quality of care and patient satisfaction, noninvasive evaluation for long-

term disease surveillance is ideal. Therefore, noninvasive methods to

assess urethral stricture recurrence after open urethral reconstruction are

critical to the overall management paradigm of urethral stricture disease.

While exploring the reconstructive urologic literature identifying both

objective and subjective metrics, we report the role of noninvasive testing

and use of questionnaires after urethral reconstruction.

Urethral stenosis, although relatively uncommon in the universe of

urologic diseases, is by no means a rare condition. It accounts for about

52% of urethral and 1.8% of urologic pathology, respectively, and

presents an estimated prevalence of 0.6%23,24. Relatively young, active

individuals are mostly affected. Its association with an unequivocal

negative impact on the quality of life, whether resulting from the disease

itself and its complications or whether consequence of the treatment(s)

employed, is well established.

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 At present, there is no doubt that reconstructive surgery in the form

of different types of urethroplasty represents the “gold standard” in the

treatment of these patients. Urethroplasty is associated with

reproductively high success rates, when properly employed.

In recent years, there has been a growing interest towards urethral

reconstruction. This expanding interest in the field of urethral

reconstruction has led to a more critical evaluation of success as well as

developing disease-specific instruments to assess surgical outcomes more

accurately with a more focus on patients’ satisfaction. Historically, most

of this reported success has been based on avoidance of secondary

procedures. Measurements of success from the patient’s perspective have

unfortunately been neglected in urethral reconstruction, and only recently,

collaborative attempts have been initiated at designing and

standardization of patient-reported outcome measures (PROMs) for

urethral reconstruction.

The purpose of the present study was to prospectively analyze

the pre and post-operative patient-reported outcomes measures describing

patient’s satisfaction and QoL after urethral reconstruction and to

compare these results with objective data.

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AIMS AND OBJECTIVES

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 AIMS AND OBJECTIVES

PRIMARY

 To assess satisfaction and quality of life after urethroplasty by patients

reported questionnaires.

SECONDARY

 To assess the short-term functional outcomes on urinary symptoms,

erectile function, urinary continence after urethroplasty.

 To analyze what factors, besides traditional surgical success, are

predictors of patient satisfaction after urethroplasty.

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REVIEW OF LITERATURE

13
 REVIEW OF LITERATURE

"Urethral stricture is defined as decrease in the caliber of urethra due to

scar resulting from tissue injury or destruction’’.25 It is the fibrotic

narrowing of the urethra composed of dense collagen and fibroblasts."

Urethral stricture disease is defined as a narrowing of the urethra

between its origin at the bladder and its outlet at the penis tip. Patients

with urethral stricture disease commonly have difficulty urinating and

usually presents with weak stream.

Urethral strictures have multiple causes including prior urinary

tract infection, catheter placement, injury to the urethra, pelvic radiation,

and surgeries. It is important to have a urethral stricture treated because

permanent injury to the bladder and/or kidneys may occur if it is not.

Strictures are managed surgically, either by endoscopic incision or

open surgical reconstruction, which often involves a graft to substitute for

the diseased urethra. Strictures are often a complex disease with a

predilection to recur, so optimal management is generally found at a

tertiary care facility where there are physicians that specialize in these

types of surgeries.

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HISTORY

Urethral stricture disease is as old as mankind. Earliest recorded

attempts to deal with strictured urethra occur in Hindu medicine. In A.D.

1520, occurred the first recorded serious epidemic of gonorrhoea &

gradually from the time subject of stricture began to receive more

attention. At this period urethral obstruction was regarded as due to

formation of obstructive growth & not to a constriction of the urethral

lumen. In ancient India, Susruta described the use of a reed catheter

lubricated with ghee.26,27 He also described the treatment of stricture by

means of dilators of metal or wood. Hippocrates & Celsus have also

given similar descriptions.

The late Professor John Blandy once stated that gentle urethral

dilatation is the best option for a urethral stricture. As Loughnane stated

more than half a century ago - 'Internal urethrotomy is an operation of

choice, not of necessity, and by itself does not cure.27 Urologists now

realize that endoscopic urethrotomy is rarely curative and the patient

often needs repeated procedures or regular self-calibration. This is not

surprising, as a urethral stricture is a scar in the underlying epithelium

and adjacent tissues, which needs to be excised and replaced by healthy

epithelium to achieve a cure. The history of surgery of urethral stricture is

replete with many such procedures using partial thickness skin grafts or

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pedicles from the penile or scrotal skin. Most, ultimately fail over a

period of time. Although the use of buccal mucosa in urology was

initially described by Humby, 28 it was after Burger 29 et al.'s description,

in 1992, that it began to be widely used. In 1996 Guido Barbagli et

al.30 described the use of the dorsal onlay graft, using buccal mucosa. The

special characteristics of the buccal mucosa made it a better substitute for

urethral reconstruction and subsequent publications led us to believe that

we had found the magic wand, which would cure this crippling malady.

On the other hand, many have found success with tunica albuginea

urethroplasty and u-shaped prostatobulbar anastomosis in some set of

population. However the long-term results of all these procedures have

highlighted their limitations. The comparability of the different

publications too is questionable, as the authors have used different criteria

to define success. It is not surprising, therefore, that controversy about the

technique continues unabated. In a recent publication in Lancet, Anthony

Atala et al., from the Wake Forest University have reported the use of

stem cells in the reconstruction of the urethra in children with post-

traumatic urethral defects.31 These results appear encouraging. Would a

tailor-made urethra from the patients' own stem cells be the ultimate

solution? Till that happens, however, we may still have to continue with

the conventional methods.

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ANATOMICAL CONSIDERATIONS

MALE URETHRA:

Male urethra has 2 different portions: anterior urethra and posterior

urethra. The posterior urethra includes membranous & prostatic region.

The anterior urethra is divided into navicularis, penile & bulbous urethra.

The male urethral length is about 18-20 cm long. It may be

considered in four regional parts:

1. Preprostatic

2. Prostatic

3. Membranous

4. Spongiose (Penile)

The verumontanum is a small hillock of tissue the urethral

lining changes from transitional cell epithelium proximally to stratified

squamous cell epithelium distally.

The external urethral sphincter is composed of circular striated

muscle within the urethral wall. It is innervated by the pudendal nerve,

originating from spinal segments S2, 3 and 4. The bladder neck

contributes to maintenance of continence in the man, although its main

role is as a genital sphincter that closes at the time of ejaculation. Its

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innervation originates in the spinal segments T10–12 with sympathetic

innervation mediated by release of noradrenaline via alphaadrenoceptors.

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 Urethra presents a double curve while the penis is in its ordinary

flaccid state. Except during the passage of fluid along it, the urethral

canal is a mere slit; in the prostatic part the slit is transversely arched(in a

transverse section), in the preprostatic and membranous portions it is

stellate, in the spongy portion transverse, while at the external orifice it is

found to be sagittal in orientation.

1. Preprostatic part: Possesses a stellate lumen with approximately

1.5 cm in length extending from the bladder neck to the superior

aspect of the prostate and ends vertically.

2. Prostatic part: It runs almost vertically downwards through the

prostate from the base to slightly in front of the apex, at the

junction of the anterior one-third and posterior two-thirds of the

gland. Features in the posterior wall (floor) of the prostatic urethra,

include the Urethral Crest, Colliculus Seminalis (verumontanum),

Prostatic Utricle and Prostatic sinuses

3. Membranous part: The membranous part is the shortest, least

distensible and, with the exception of the external orifice, the

narrowest section of the urethra. It descends with a slight ventral

concavity from the prostate to the bulb of the penis, passing

through the perineal membrane, about 2.5 cm postero-inferior to

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 the pubic symphysis.

4. Spongiose part: It is contained in the corpus spongiosum of the

penis, passes through the bulb, body and glans penis and terminates

at the external urethral orifice close to the tip of the glans. It has

two dilatations –the Intrabulbar fossa and the Terminal fossa

(Navicular fossa).

The adult female urethra is about 4 cm long and is muscular in

its proximal four-fifths. This musculature is arranged in an inner

longitudinal coat that is continuous with the inner longitudinal fibers of

the bladder and an outer circular coat that is continuous with the outer

longitudinal coat of the bladder. These outer circular fibers comprise the

sphincteric mechanism. The striated external sphincter surrounds the

middle third of the urethra.

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PARTS OF URETHRA

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MUCOUS MEMBRANE

Above the Colliculus – lined by transitional epithelium.

Colliculus to terminal fossa – lined by stratified columnar epithelium two

or three layers thick.

Terminal fossa to external urethral orifice – lined by non-keratinized

stratified squamous epithelium.

LININGS OF URINARY BLADDER

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URETHRAL SPHINCTERS:

a) Internal urethral sphincter (Internal sphincter vesicae): It

controls the vesical neck and the prostatic urethra above the

ejaculatory ducts. It is composed of non striated muscle and

supplied by sympathetic and parasympathetic fibres from the

vesical plexus.

b) The external urethral sphincter: It surrounds the membranous

urethra; it consists of striated muscle and is supplied by the

perineal branches of the pudendal nerve (S2 S3 and S4); it is

voluntary after early infancy. (Sharplip et al).

The location of external urethral sphincter corresponds

anatomically to the zone where maximal urethral closure pressures are

normally recorded. This striated muscle sphincter is morphologically

adopted to maintain tone over relatively long periods without fatigue and

plays an important active role in producing urethral occlusion at rest.

It remains to be determined, however, whether the force exerted by

the sphincter is maximal at all times between two consecutive acts of

micturition or whether additional motor units are recruited during

coughing, sneezing etc. to enhance the occlusive force on the urethra

during these events. The external sphincter is innervated by nerve fibres

which travel via several routes, not exclusively via the pudendal nerves.

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 The clinical relevance of this arrangement is that pudendal

blockade or neurectomy when performed in order to reduce urethral

resistance, will not achieve the desired effect since much of the motor

innervation of the striated sphincter remains intact after these procedures

are done.32

DISSECTION OF PROSTATE SHOWING THE FIBRES OF THE

EXTERNAL SPHINCTER SURROUNDING THE MEMRANOUS

URETHRA AND PARTIALLY CRADLING THE

INFERIORPORTION OF THE PROSTATE.

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ARTERIAL SUPPLY, VENOUS AND LYMPHATIC DRAINAGE

ARTERIAL DRAINAGE

Inferior vesical, middle rectal, internal pudendal and the urethral

branch of the artery to the bulb of penis, which is derived from the

internal pudendal artery. The deep penile structures receive their arterial

supply from the common penile artery, which arises from the internal

pudendal artery.

VENOUS DRAINAGE

Venous drainage corresponds to the arteries.

The superficial dorsal vein lies external to bucks fascia. The deep dorsal

vein is placed beneath buck’s fascia and lies between the dorsal arteries.

The veins connect with the pudendal plexuses which drain into the

internal pudendal vein.

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BLOOD SUPPLY OF URETHRA

26
LYMPHATIC DRAINAGE

The Prostatic and the Membranous urethra drain into the internal

and external iliac lymph nodes. The Spongy part drains into the deep

inguinal and sometimes into the external iliac lymph nodes.

NERVE SUPPLY

Most of the urethra is supplied by autonomic nerves and the

terminal part by some somatic nerves.

Sympathetic fibers are derived from the superior hypogastric

plexus: the preganglionic fibers come from L1 and L2 segments.

Parasympathetic fibers are derived from pelvic splanchnic nerves,

carrying preganglionic fibers from S2, S3 and S4 segments. Somatic

fibers are derived from the urethral branch of the pudendal nerves.

EVOLUTION OF URETHRAL STRICTURE TREATMENT

The goal of urethral reconstruction is to restore urinary flow while

maintaining quality of life with minimal side effects. An increase in the

number urologists has aided the shift from palliative, minimally invasive

procedures such as repeated urethral dilations or direct vision internal

urethrotomy towards definitive repair via urethral reconstruction. For

example, in 2004, urethral stricture disease was treated by urethroplasty

in only 2.3% of the time as opposed to 7.6% in 2s012.33 This change in

27
attitude has resulted in durable patency rates with lower need for repeated

procedures, including self-obturation by patients. With increasing

utilization of urethroplasty, however, some patients with a patent urethra

after urethroplasty are not “satisfied” with their surgery experience

despite unobstructed voiding. This can lead to discordance of perceived

success between patients and physicians34. In addition, given that the

primary focus of urethral reconstruction is improving quality of life,

urologists have become more interested in the patient’s subjective

experience following urethroplasty. This includes addressing aspects of

urethroplasty that are not related to obstructed voiding including sexual

function, pain, cosmetic results, and overall voiding quality (e.g., lack of

post-void dribbling or urine spraying). As such, there is growing

consensus among reconstructive urologists that there should be

standardized documentation of the patient’s subjective assessment of their

symptoms to better understand their perspective and to allow improved

comparison of surgical outcomes among surgeons.

What Is a “Successful” Urethroplasty?

A historical perspective towards a “successful” urethroplasty is the

lack of need for secondary procedures after urethroplasty. Over 75% of

published literature between 2000 and 2008 used this definition as

“success” due to ease of quantification for scientific research 35. However,

28
there are many disadvantages that include lack of input from patients or

clinical evaluation of the reconstructed urethra and urine flow. For

instance, there are patients with significant bother from post-void

dribbling or persistent dysuria after urethroplasty with no anatomic

recurrence of stricture or a need for re-intervention who are overall not

happy with their surgical experience. This group needs to be recognized

in order to achieve the ultimate goal of patient satisfaction after

urethroplasty36.

Other clinical and patient-reported tools have been used to

demonstrate success after urethroplasty. One non-invasive modality for

screening of urethral stricture disease and also identifying recurrence of

disease is uroflowmetry in combination with post-void residual

measurement. It has never been validated as a standalone tool for

recurrence screening; however, when these voiding curves were

combined with patient-reported symptoms, it has demonstrated 51%

sensitivity, 98% specificity, 90% positive predictive value, and 86%

negative predictive value.37 Morey et al. were first to use the American

Urological Association Symptom Score (AUA-SS) in correlation with

uroflowmetry and retrograde urethrogram findings to predict recurrence

of urethral stricture disease.38 In a prospective report, Heyns et al. has

combined uroflowmetry with AUA-SS and demonstrated 68% specificity

29
for initial diagnosis of urethral stricture disease but its role in the

postoperative setting is unknown.39 Erickson et al. correlated

uroflowmetry parameters with anatomic recurrence on cystoscopy after

urethroplasty and showed good predictive value but only in men less than

40 years old.40 They hypothesize that contributing factors such as

enlarged prostate or altered bladder dynamics in older men can make the

results unreliable in the older age group. These results also lack input

from patients and are not validated in a prospective setting.

Cystoscopic evaluation of reconstructed urethra is considered gold

standard after urethroplasty to identify stricture recurrence; however,

heterogeneous methods of reporting “success” can hinder reporting of

successful outcomes. Using a large multi-institution database, it has been

shown that anatomic recurrence, defined as stricture that is visible on

postoperative cystoscopy, occurs in 11.5% and 22.5% of patients

undergoing excision/primary anastomotic urethroplasty or graft

urethroplasty, respectively41. However, up to 35% of these subjects are

asymptomatic and would have been considered a success if “the need for

intervention” was used as a definition for success. The natural history and

long-term outcomes of this group with functional success but anatomical

recurrence are unknown but it highlights the need for refining these

30
definitions and adding a patient-reported component to consider patient’s

perspective when comparing different urethroplasty techniques.

Given that outcomes following urethral reconstruction are very

subjective beyond urethral patency (e.g., terminal dribbling, urine

spraying following meatal reconstruction, scrotalgia), standardized

assessment of subjective outcomes is essential. A condition-specific

patient-reported outcome measure can help to meet this need. Bertrand et

al. in 2016 demonstrated that unsatisfied men after urethroplasty had

higher rates of disease recurrence on cystoscopy and worse uroflow

parameters as expected. However, on multivariate analysis including both

patient-reported and clinical parameters after adjusting for disease

recurrence and age, persistence in voiding symptoms (weak stream),

genitourinary pain, and postoperative sexual function alterations were the

greatest independent drivers of postoperative dissatisfaction and uroflow

parameters fail to demonstrate significant contribution to satisfaction. 42

This study emphasizes that patient-reported symptoms are equally, if not

more, important drivers of overall patient satisfaction and should be

included in any instrument used to assess success after urethroplasty.

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What Is a PROM?

Patient-reported outcome measures (PROMs) are health

questionnaires that patients complete before and after an intervention to

determine whether their symptoms, daily function, or health-related

quality of life have changed.43,44 Several validated PROMs are routinely

used in surgical and nonsurgical fields in order to indicate patient-

perceived benefit from an intervention. They are necessary for

preoperative patient counseling, performance benchmarking, and resource

allocation45. There are many PROMs currently in routine urologic

practice, and probably the most well recognized is the AUA-SS, also

known as USS-PROM. The most useful PROM is the one that is

validated for a specific condition with patient input at each phase of

development. Urethral stricture disease has a relatively expanded physical

and emotional impact on an individual’s life from voiding and sexual

function to emotional consequences such as worry, embarrassment, and

depression. All these aspects need to be considered when designing a

comprehensive disease-specific PROM, and there is an emerging field of

research addressing this need in urethroplasty literature.

A comprehensive PROM development process involves the patient

during each step. These steps include

(1)Identifying the conceptual model,

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(2)Adjusting the conceptual model/drafting a preliminary instrument,

(3)Confirming the conceptual model/ assessing other measurement

properties,

(4)Collecting/analyzing/interpreting data, and

(5)Modifying the instrument. Terwee et al. has provided explicit criteria,

based on recommendations from the Scientific Advisory Committee of

the Medical Outcomes Trust that oversees development of PROMs 46.

These criteria include the following:

1) Content validity: How well is the conceptual domain covered by the

instrument?

2) Internal consistency: The precision of a measurement scale based on

intercorrelations.

3) Criterion validity: How well do instrument scores relate to gold

standard?

4) Construct validity: Do scores on a particular questionnaire relate to

other measures in a manner that is consistent with measured

hypotheses?

5) Reproducibility: (a) Agreement, how well do scores on repeated

measures agree with another?

33
 (b) Reliability, how well are patients distinguished from another

despite measurement error?

6) Responsiveness: How well does a questionnaire detect change over

time?

7) Floor and ceiling effects: The number of patients who achieved the

highest/lowest possible score.

8) Interpretability: How well can you assign easily understood meaning

to an instrument’s quantitative scores?

Currently, the Trauma and Urologic Reconstruction

34
COMMON PROMS USED IN URETHROPLASTY LITERATURE

Disease Non-specific Voiding PROM

Table 1 summarizes the common PROMs related to voiding

complains used in the urethroplasty literature. The AUA-SS is one of the

first symptom score questionnaires used in urology that was introduced in

1992. It was originally designed for men with benign prostatic

hyperplasia, and despite poor specificity, it has good utility in assessing

symptom severity and treatment outcomes.47-49 The utility of AUA-SS as

an outcome assessment tool in urethral stricture disease was initially

investigated by Morey et al. in 1998. They correlated symptom scores

obtain by AUA-SS with radiographic retrograde urethrograms and

uroflow rates postoperatively and observed a significant reduction in

AUA-SS following urethroplasty and a significant inverse correlation

between AUA-SS and maximum urinary flow rates and concluded that

this index has clinical validity as an adjunct outcome assessment tool

after urethroplasty.38 In a prospective study of anterior strictures treated

with dilation or DVIU, a combination of AUA-SS and uroflow

parameters has yielded 93% sensitivity, 68% specificity, 78% positive

predictive value, 89% negative predictive value, and 82% overall

accuracy.39 The use of AUA-SS has shown internal consistency and

reliability for men with lower urinary tract symptoms from benign

35
prostatic hypertrophy, but it does not have content validity in urethral

stricture disease and is considered an incomplete PROM.

36
 Nuss et al. have investigated this concern where urinary symptoms

of 214 patients who underwent urethroplasty were retrospectively

reviewed. They concluded that although most common presenting

symptoms are addressed in AUA-SS (weak stream 49%, incomplete

emptying 27%), up to 21% of patients’ symptoms would not be captured

by the AUASS. The most common symptoms were spraying of urine and

dysuria that were present in 13 and 10% of their population. Less

common symptoms included post-void dribbling, hesitancy, and

incontinence. In addition, the AUA-SS has been specifically inadequate

in capturing symptoms of patients with penile urethral strictures and

trauma-related and lichen sclerosus-related strictures and 10% of men

with urethral stricture disease did not have any voiding symptoms calling

for the need for disease specific PROM50.

Another PROM that has been applied to urethral stricture disease is

the Core Lower Urinary Tract Symptom Score (CLSS). This instrument

was designed in 2008 in order to provide a comprehensive questionnaire

to assess ten core urinary symptoms from the symptom panel of the

International Continence Society. This PROM evaluates frequency,

nocturia, urgency, urinary incontinence, quality of urinary stream, pain,

and quality of life. Although it has an overall quality of life measure and

two questions assessing bladder and urethral pain which are known

37
predictors of postoperative dissatisfaction after urethroplasty, during the

validation process of this PROM, no patients with urethral stricture

disease were included, and it fails to assess common complains in

urethral stricture disease such as urine spraying and dysuria.51 The

Incontinence Symptom Index (ISI) is another instrument that has been

used in adjunction with the AUA-SS to assess urethroplasty success.52

This instrument was developed in 2003, and although there is a bother

component, it emphasizes primarily on urinary incontinence and has

never been validated for urethral stricture disease53.

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Disease-Specific Voiding PROM

In 2002, the first disease-specific PROM was published in the

urethroplasty literature by Kessler et al.34 It was not validated and was

never adopted for widespread clinical use. It includes questions assessing

urinary tract, voiding and sexual function, overall satisfaction, and

miscellaneous impairments after urethroplasty. Using this non-validated

PROM, they reported 78% overall satisfaction with surgery and noted

that the impact on sexual function was a significant marker for potential

disappointment. An interesting finding of this study was how differently

patients consider the outcomes of urethroplasty compared to surgeons. Of

30 patients in whom urethroplasty was considered a failure by clinical

measures, 24 were “satisfied or highly satisfied” with the surgical

outcome.

The only PROM that has been designed specifically for patients

with urethral stricture disease is published in 2011 by Jackson et al.

(Urethral Stricture Surgery PROM or USS PROM). The researchers used

a previously published research method to expedite PROM creation in a

cost-efficient manner. PROM development involved interviews of a

patient focus group to gather important content. Existing PROMs not

specifically validated for urethral stricture disease were then explored for

relevant content based on the patient interviews and then included in the

39
planned PROM based on expert opinion from physicians. The

subsequently developed USS PROM includes a lower urinary tract

symptoms (LUTS) construct of six summative questions, one separate

LUTS-related quality of life question, and a voiding picture. It is then

followed by a five-item questionnaire to assess overall quality of life and

two questions addressing overall patient satisfaction and a visual analog

scale of health status. The pilot study of this PROM demonstrated

excellent psychometric values including validity, test-retest reliability,

internal consistency, and responsiveness and was found to correlate with

maximum flow rates as criterion validity45. The results of application of

this PROM before and 2 years after bulbar and penile urethroplasty in 46

men showed durable improvement in all domains assessed. 54 The

subgroup of patients who required re-intervention due to stricture

recurrence (15%) reported lower scores in all domains of USS PROM

which demonstrates correlation between anatomic and functional

outcomes. In a critical review of all PROMs in urethral stricture disease,

Voelzke concluded that USS PROM is the only PROM that shows

adequate psychometric values and is considered a “key first step” towards

using a condition-specific PROM55. However, this PROM is not perfect;

the questions were generated from questionnaires validated for other

health conditions and not generated de novo from the words of the

patients. This has resulted in a lack of uniformity among items and

40
response choices (i.e., choices vary from three to five responses across

the included items). In addition, sexual function and oral mucosa

morbidity are not included in this PROM. Further, only one stricture

specific quality of life question is present56.

Disease Non-specific Sexual PROM

The summary of the PROMs used to assess sexual function before

and after urethroplasty is presented in Table 2. In a historical cadaveric

study on neuroanatomy of erection, Lue et al. showed that most of the

cavernous nerve fibers that supply the corpus spongiosum occupy the 1

and 11 o’clock positions at the level of convergence of the crura of the

corpora cavernosa. Given the elasticity of the corpus spongiosum,

anterior urethral reconstruction should not predispose patients to long-

term erectile dysfunction (ED).57

However, Mundy et al. initially raised the concern for sexual

dysfunction after urethroplasty in 1993 when they reported 5% rate of

permanent ED after anastomotic urethroplasty and 0.9% rate after graft

patch urethroplasty.58 The topic has been controversial and several

authors have reported different and often contradicting sexual function

outcomes after urethroplasty59.

41
42
 The first authors to systematically evaluate sexual dysfunction after

urethroplasty using a PROM were Coursey et al. in 2001. They used a

validated questionnaire designed by the authors to assess perceived

changes in satisfaction with erection, erect penile length and angle, and

change in these parameters over time and used patients undergoing

circumcision as the control group. They reported on average 30%

decreased satisfaction with erections with slight difference based on

technique of urethroplasty. The authors were surprised by the high rate;

however, they noted that the deterioration improves over time and erectile

dissatisfaction is similar among the control group after routine

circumcision. The authors emphasized the importance of unfiltered data

that was collected by patients at home and not subject to physician bias,

coaching, or misinterpretation60.

The well-recognized International Index of Erectile Function

(IIEF) and the short five-item score version (IIEF-5) have been used more

commonly in previous reports. These tools are validated, multi-

dimensional, self-report instruments widely used for evaluation of male

sexual function and recommended as primary endpoints for clinical trials

43
of ED. It is divided into five domains of sexual function including erectile

function, orgasm, intercourse satisfaction, sexual desire, and overall

satisfaction61.

The complete IIEF PROM has been used by Anger et al. in 2007 to

assess sexual function before and after different variations of bulbar

urethroplasty, and after 6 months of follow-up, no significant difference

before and after surgery was observed.62 In a prospective study, Erickson

et al. used the IIEF-5 to evaluate erectile function before and after

different types of urethroplasty. They noted 38% overall rate of ED

postoperatively, of which 90% fully recovered after a mean of 190 days.

Bulbar compared to penile and primary anastomosis and compared to

graft urethroplasty had more deleterious effect on erections 63. The same

IIEF-5 PROM in addition to the Sexual Life Quality Questionnaire

(SLQQ) was used in a study by Xie et al. in 2009. [40] The latter PROM

addresses specific aspects of sexual quality, including frequency of

lovemaking, duration of lovemaking, ease of insertion, ease of achieving

orgasm, ease of initiating lovemaking, pleasure of anticipation, carefree

feelings, pleasure of orgasm, pleasure of overall experience, and partner’s

pleasure of experience in addition to overall quality of life. Xi et al.

observed significant decline in sexual function 3 months after

44
urethroplasty that was more pronounced in younger patients and after

posterior urethroplasty.

They eventually noted a rebound to pre-op values after 6 months

but identified stricture location and end-to-end anastomosis of stricture as

predictors of worse ED64. Other sexual function PROMs that have been

used in urethroplasty literature are Brief Male Sexual Function Inventory

(BMSFI)63,65,66 and Men’s Sexual Health Questionnaire (MSHQ)63,67. In a

retrospective study, Erickson et al. used the three ejaculatory function

sections of BMSFI and found an overall increase in postoperative

ejaculatory score; however, as the patients were asked to complete

preoperative scores after the surgery, the conclusions of the study were

criticized by recall bias among the participants.68 In a subsequent

prospective study, Erickson et al. studied the effect of urethroplasty on

ejaculatory function using the seven-question section of MSHQ on

ejaculatory frequency, latency, volume, force, pain and pleasure, and dry

ejaculation in 59 men. The overall rate of poor preoperative ejaculatory

function was 25% and most common presentations were poor volume,

poor vigor, and pain with ejaculation. Overall change in MSHQ scores

was minimal; however, closer inspection of individual patients revealed

that ejaculatory function was stable in 70%, improved in 19%, and

decreased in 11%63. MSHQ is a validated questionnaire that was

45
developed in 2004 by Rosen et al. and is specifically designed to evaluate

different aspects of ejaculatory function although the psychometrics of

application of this questionnaire to the urethroplasty population has not

been thoroughly investigated. In particular, it has been hypothesized that

patients perceive improvement in one domain (e.g., relief of pain at

ejaculation) associated with global improvement in ejaculatory function

and tend to report subjective improvement in volume and vigor63. Similar

to voiding PROMs, none of these questionnaires have been vigorously

validated in pre- and post-urethroplasty population.

Disease-Specific Sexual PROM

An initial attempt at creating a disease-specific PROM for sexual

function change after urethroplasty has been proposed by Barbagli et al.

who used an expert-created but non validated PROM. This PROM was

used to examine the effect of bulbar anastomotic urethroplasty on sexual

function. The PROM focused on changes in ejaculatory function (force of

ejaculation and fertility), neurovascular penile disorder (change in penile

sensation and glans abnormalities), and overall satisfaction. In a

retrospective review of 153 young patients undergoing excision and

primary anastomosis for bulbar stricture, they noted no chordee or de

novo ED after surgery. However, they reported 23% ejaculatory

dysfunction, 1.6% a cold glans during erection, 11.6% a glans that was

46
neither full nor swollen during erection, and 18.3% decreased glans

sensitivity.69 This study lacks preoperative measures and the timing of

postoperative interviews has been inconsistent, making the interpretation

of the results difficult.

The only validated sexual function PROM is reported by Coursey,

as discussed previously.60 This PROM focuses only on erectile function

and does not address ejaculatory function, overall patient satisfaction, or

quality of life. In addition, although content validity is addressed by the

designers of the PROM, other quality criteria for an adequate disease

specific PROM including internal consistency, construct validity,

reproducibility, responsiveness, floor/ceiling effect, and interpretability

are lacking55.

47
ERECTILE DYSFUNCTION AFTER URETHROPLASTY

An understanding of penile anatomy is fundamental to management of

erectile dysfunction (ED).70 The common penile artery, which derives

from the internal pudendal artery, branches into the dorsal, bulbous

urethral, and cavernous arteries.

VASCULAR ANATOMY OF THE PENIS

The dorsal artery provides for engorgement of the glans during

erection, while the bulbourethral artery supplies the bulb and corpus

spongiosum. The cavernous artery effects tumescence of the corpus

cavernosum, and thus is principally responsible for erection. The

48
cavernous artery gives off many helicine arteries, which supply the

trabecular erectile tissue and the sinusoids. These helicine arteries are

contracted and tortuous in the flaccid state and become dilated and

straight during erection.71

Venous drainage of corpora originates in tiny venules that lead

from the peripheral sinusoids immediately beneath the tunica albuginea.

These venules travel in the trabeculae between the tunica and the

peripheral sinusoids to form the subtunical venous plexus before exiting

as the emissary veins.71

These images depict penile anatomy. The major blood vessels to the

corpora cavernosa enter through tributaries from the main vessels

running along the dorsum of the penis.

49
 Sexual behavior involves the participation of autonomic and

somatic nerves and the integration of numerous spinal and supraspinal

sites in the central nervous system (CNS). The penile portion of the

process that leads to erections represents only a single component.

The hypothalamic and limbic pathways play an important role in

the integration and control of reproductive and sexual functions. The

medial preoptic center, paraventricular nucleus, and anterior

hypothalamic regions modulate erections and coordinate autonomic

events associated with sexual responses.

Afferent information is assessed in the forebrain and relayed to the

hypothalamus. The efferent pathways from the hypothalamus enter the

medial forebrain bundle and project caudally near the lateral part of the

substantia nigra into the midbrain tegmental region.

Several pathways have been described to explain how information

travels from the hypothalamus to the sacral autonomic centers. One

pathway travels from the dorsomedial hypothalamus through the dorsal

and central gray matter, descends to the locus ceruleus, and projects

ventrally in the mesencephalic reticular formation. Input from the brain is

conveyed through the dorsal spinal columns to the thoracolumbar and

sacral autonomic nuclei.

50
 The primary nerve fibers to the penis are from the dorsal nerve of

the penis, a branch of the pudendal nerve. The cavernosal nerves are a

part of the autonomic nervous system and incorporate both sympathetic

and parasympathetic fibers. They travel posterolaterally along the prostate

and enter the corpora cavernosa and corpus spongiosum to regulate blood

flow during erection and detumescence. The dorsal somatic nerves are

also branches of the pudendal nerves. They are primarily responsible for

penile sensation.72

Erections occur in response to tactile, olfactory, and visual stimuli.

The ability to achieve and maintain a full erection depends not only on

the penile portion of the process but also on the status of the peripheral

nerves, the integrity of the vascular supply, and biochemical events within

the corpora.

Sexual stimulation causes the release of neurotransmitters from the

cavernosal nerve endings and relaxation factors from the endothelial cells

that line the sinusoids. NO Synthatase produces NO from L-arginine.

This, in turn, produces other muscle-relaxing chemicals such as cGMP

and cyclic adenosine monophosphate (cAMP), which work via calcium

channel and protein kinase mechanisms. This results in the relaxation of

smooth muscle in the arteries and arterioles that supply the erectile tissue,

producing a dramatic increase in penile blood flow.

51
 Relaxation of the sinusoidal smooth muscle increases its

compliance, facilitating rapid filling and expansion (40-52% of the

corpora cavernosa tissue is composed of smooth muscle cells). The

venules beneath the rigid tunica albuginea are compressed, resulting in

near-total occlusion of venous outflow. These events produce an erectio

with an intracavernosal pressure of 100 mm Hg.

Additional sexual stimulation initiates the bulbocavernous reflex.

The ischiocavernous muscles forcefully compress the base of the blood-

filled corpora cavernosa, and the penis reaches full erection and hardness

when intracavernous pressure reaches 200 mm Hg or more. At this

pressure, both the inflow and outflow of blood temporarily cease.

Detumescence results from the cessation of neurotransmitter

release, the breakdown of second messengers by PDEs, and sympathetic

nerve excitation during ejaculation (see image below). Contraction of the

trabecular smooth muscle reopens the venous channels, allowing the

blood to be expelled, which results in flaccidity.

Anterior urethroplasty has a probability of causing ED in as much

as 20% of patients. The type of urethroplasty has no significant effect on

ED. Recovery of erectile function occurs within 6 months

of urethroplasty.73

52
 Established beliefs concerning outcomes following anterior

urethral reconstruction are changing, both with regards to the genital

cosmetics and to the impact on sexual activity. Today, the aim

of stricture repair is not only to reinstate urinary function but also to

safeguard sexual activity and guarantee genital cosmesis. A thorough

evaluation of anterior urethroplasty results should include the sexual

viewpoint which appears to play an important role in overall post-

operative patient satisfaction. The most commonly reported sexual

problems following anterior urethroplasty include: erectile and

ejaculatory dysfunction, penile curvature or shortening, dissatisfaction

with genital cosmetic appearance, sensorial impairment of glans. The

prevalence of specific post-operative sexual problems may be related to

the site of reconstruction (penile or bulbar) and to the technique of

urethroplasty employed. In penile urethral reconstruction, the wide use of

buccal mucosa grafts seems to excel the use of skin flaps which easily

distort the cosmesis and elasticity of the penis. In bulbar reconstructions,

graft augmentation techniques seem to impact less on sexual outcome

than excision anastomotic techniques. Therefore, the policy of primarily

indicating an excision anastomotic procedure, whenever possible, should

come under scrutiny. Eventual sexual outcomes should be incorporated in

the choice of the optimal anterior urethral reconstruction and in pre-

operative patient counselling.74

53
 Erectile function is a predictor of overall patient satisfaction after

repair of urethral strictures75. Although male urethral reconstruction has

become increasingly widely used, few long-term, patient-reported

outcome data are available regarding erectile function after urethral

operation. Previous studies have focused primarily on stricture recurrence

and incontinence. However, erectile function is usually discussed as only

a small part of broader reports of operative outcomes. Some reports have

indicated that the age of the patient, sexual function before surgery,

elapsed time after surgery, and stricture length and severity are likely to

have direct influences on long-term erectile function after treatment 75,76

In recent years, various surgical techniques have been used to perform

one-stage repair of urethral strictures. However, the early and late

complications of urethral reconstruction have not been fully described in

the literature. Several studies have commented on the incidence of ED.

Current data indicate that the incidence of impotence after urethral

reconstruction ranges from 16.2% to 72% 77.

A recent study of 200 patients with urethral strictures indicated that

post-operative impotence of duration less than 3 months occurred in 53%

of patients who underwent anastomosis, compared with 33% who

underwent patch repair. However, when observed over longer follow-up

intervals, these rates dramatically decreased to 5% and 0.9%,

54
respectively 78. Corriere 79 evaluated erectile function in 60 patients with

delayed repairs of complete posterior urethral ruptures. Of the patients

who were potent pre-operatively,80 (48%) complained of ED post-

operatively and 9% regained potency at 1 year. This report is in

agreement with our own findings that erectile function lost in the

immediate post-operative period may be regained at later time intervals.

Recovery of erectile function may be attributed to increases in penile

sensation, the gradual subsiding of edema and inflammation at the

surgical site and psychosocial factors.

As the incidence of complete impotence is reported to be 5% at age

40 and 15% at age 70, age was considered as a confounding variable in

post-operative ED. 74.4% of all patients were less than 50 years of age,

suggesting that age was not a confounding variable. However, patients

younger than 40 years could regain erectile function 6 months after

surgery. This observation indicated that age may be related to the

recovery of erectile function.81

Lue et al82 demonstrated by cadaver dissection that most of the

cavernous nerve fibers that supply the corpus spongiosum do not pass

through the tunica albuginea. These nerves occupy the 1 and 11 o'clock

positions at the level of convergence of the crura of the corpora

cavernosa. In addition, the corpus spongiosum is highly elastic and can be

55
readily re-anastomosed after mobilization and stricture excision, even in

cases of long strictures83. Taken together, these findings suggest that

anterior urethral reconstruction should not predispose patients to long-

term ED. Eltahawy et al.84 conducted a longitudinal study of 260 patients

undergoing anterior urethral reconstruction. ED occurred in only six

(2.3%) patients, all of whom had good erectile function pre-operatively.

By comparison, patients with posterior urethral strictures usually had

more scar tissue, which makes it more difficult for the surgeon to

mobilize the corpus spongiosum. Consequently, the neurovascular bundle

is more easily damaged during surgery, which increases the incidence of

ED. These findings may be explained by the observations described

above. In addition, the inadequate excision of scar tissue at the site of

urethral stricture may contribute to persistent ED.

In recent reports, the incidence of impotence after urethral

reconstruction using various flaps or grafts ranged from 0% to 3% 85,86 No

change was expected in erectile function in those who underwent the end-

to-end anastomosis, as Koraitim87 suggest that impotence is usually

related to the original trauma and rarely (2%) to urethroplasty itself. In

addition, erectile function was significantly decreased in patents whose

length of urethral stricture ranged from 2 to 5 cm after the procedure. It

should be explained by the fact that the anastomosis procedure was often

56
chosen for those patients.

The data indicate that ED occurs after urethral reconstruction for

the repair of urethral strictures. The identified risk factors for ED,

including, but not limited to, the location of the stricture and the choice of

surgical technique. The posterior urethral stricture and end-to-end

anastomosis procedures have a particularly strong association with

erectile function. These results may be relevant to the medical and

surgical management of patients with urethral strictures.

In men who sustain a pelvic fracture-urethral distraction defect

(PFUDD) injury, repairing the urethra involves a complicated urethral

anastomosis located posteriorly at the junction of the membranous and

prostatic urethra. In one study when a post- operative semen analysis and

questionnaire study to determine the effect of PFUDD injuries and

PFUDD repair on ejaculatory function and fertility in these men. Patients

were contacted and given a questionnaire eliciting details about their

ejaculatory function and history of fertility. Those interested in future

paternity were asked to provide semen for analysis. In all,71 men were

contacted; all claimed to have antegrade ejaculation, although few

reported having a lower ejaculatory volume than before their injury, and

few claimed that his ejaculate was delayed. All men in the present series

who had PFUDD injuries repaired had antegrade ejaculation. It appears

57
that the risk of damage to the ejaculatory ducts from either a PFUDD or

the subsequent Urethral reconstruction is low. However, other associated

injuries at the time of the pelvic fracture might place men at greater risk

of infertility.88

A consecutive series of 200 patients undergoing urethroplasty has

been reviewed to assess the results and complications of surgery and

thereby assess the role of urethroplasty in the treatment

of urethral strictures with particular reference to the current interest in

intraluminal "stenting" of strictures. Anastomotic Urethroplasty for post-

traumatic strictures and "patch" urethroplasty for post-infective strictures

give satisfactory results which at present do not seem to be bettered by

any other form of treatment. Urethroplasty for so-called "ischaemic"

strictures gives less satisfactory results which could almost certainly be

improved upon by intraluminal "stenting" or some other novel form of

treatment. The incidence of impotence, temporary and permanent,

after urethroplasty is probably greater than is generally realised and the

aetiology of this complication warrants serious investigation as this is the

single most important limiting factor in urethroplasty.89

58
INCONTINENCE AFTER URETHROPLASTY

Urinary incontinence (UI) is any involuntary leakage of urine. It can be

a common and distressing problem, which may have a profound impact

on quality of life. . The normal male urinary sphincter mechanism may be

divided into two functionally separate units, the proximal urethral

sphincter (PUS) and the distal urethral sphincter (DUS) (Hadley et al,

1986). The PUS consists of the bladder neck, prostate, and prostatic

urethra to the level of the verumontanum. It is innervated by autonomic

parasympathetic fibers from the pelvic nerve. This portion of the

continence mechanism is removed during prostatectomy, leaving only the

DUS to prevent urinary leakage. The DUS extends from the

verumontanum to the proximal bulb and is composed of a number of

structures that help to maintain continence. The male DUS complex is

composed of the prostatomembranous urethra, cylindrical

rhabdosphincter (external sphincter muscle) surrounding the

prostatomembranous urethra, and extrinsic paraurethral musculature and

connective tissue structures of the pelvis.

Continence and micturition involve a balance between

urethral closure and detrusor muscle activity. Urethral pressure normally

exceeds bladder pressure, resulting in urine remaining in the bladder. The

proximal urethra and bladder are both within the pelvis. Intraabdominal

59
 pressure increases (from coughing and sneezing) are transmitted to

both urethra and bladder equally, leaving the pressure differential

unchanged, resulting in continence. Normal voiding is the result of

changes in both of these pressure factors: urethral pressure falls and

bladder pressure rises.

Micturition requires coordination of several physiological

processes. Somatic and autonomic nerves carry bladder volume input to

the spinal cord, and motor output innervating the detrusor, sphincter, and

bladder musculature is adjusted accordingly. The cerebral cortex exerts a

predominantly inhibitory influence, whereas the brainstem facilitates

urination by coordinating urethral sphincter relaxation and detrusor

muscle contraction.

As the bladder fills, sympathetic tone contributes to closure of the

bladder neck and relaxation of the dome of the bladder and inhibits

parasympathetic tone. At the same time, somatic innervation maintains

tone in the pelvic floor musculature as well as the striated periurethral

muscles.

When urination occurs, sympathetic and somatic tones in the

bladder and periurethral muscles diminish, resulting in decreased urethral

resistance. Cholinergic parasympathetic tone increases, resulting in

bladder contraction. Urine flow results when bladder pressure exceeds

60
urethral resistance. Normal bladder capacity is 300-500 mL, and the first

urge to void generally occurs between bladder volumes of 150 and 300

mL.

Incontinence occurs when micturition physiology, functional

toileting ability, or both have been disrupted. The underlying pathology

varies among the different types of incontinence (ie, stress, urge, mixed,

reflex, overflow, and functional incontinence).

Between 1979 and 1998, in a study 13 patients were managed with

postoperative incontinence after bulboprostatic anastomoticurethroplasty.

Of these patients, nine had undergone a transpubic approach and four a

perineal approach. The causes of urinary incontinence in the 13 patients

were as follows. Ten patients had derangement of the proximal

sphincteric mechanism (the distal sphincteric mechanism is usually

destroyed as a result of trauma and/or during urethroplasty). These 10

patients were managed by placement of an anterior bladder tube, after the

failure of pharmacological manipulations. Two patients who had been

managed by transpubic urethroplasty experienced complications due to

vesicourethral fistulae. They were managed by excision of the tract and

repair of the bladder and the urethral defects. One patient, who was

managed additionally by visual urethrotomy (for postoperative

obstruction after perineal bulboprostatic anastomosis), experienced

61
complications due to a false tract between the bladder and urethra. He

was managed by bulboprostatic anastomosis and excision of the false

tract.

After 1-6 years follow-up, the outcome of the 10 patients who

underwent placement of a bladder tube was good in four (40%), fair in

three (30%) and poor in two (20%). The two patients who presented with

vesicourethral fistulae regained continence after excision of the fistulae.

The patient who had a false tract between the bladder and urethra

regained continence after revision of the bulboprostatic anastomosis and

excision of the fistulous tract. The proximal sphincteric mechanism

should be fully evaluated before performing bulboprostatic anastomosis.

Placement of a bladder tube is a good option for managing urinary

incontinence. Vesicourethral fistulae are an unrecognized cause of urinary

incontinence following transpubic urethroplasty. Visual urethrotomy

should only be used in short, passable strictures.90

62
PRINCIPLES OF URETHRAL RECONSTRUCTION

Most of the strictures in today’s era are as a result of road traffic

accidents. As is very common, early resuscitative take precedence over

everything else in saving the life of the subject. Association of various

other organ systems which may have a direct effect on the mortality or

morbidity of the patient will immediately warrant early diagnosis and

management. Amidst this it may sometimes so happen that urethral

injuries may be diagnosed a little late unless there are frank signs that

catch the medical personals attention or the patient himself complaints of

problems in passing urine. These injuries may not have a major role in

determining the mortality of the subject but they carry with them a great

morbidity. Initially a single gentle attempt at per urethral catheterization

with foley’s catheter is attempted failing which a urinary diversion in the

form of a suprapubic cystostomy is performed. A delayed reconstruction

of the urethra is preferred as it gives enough time for the patient to

recover from his other associated injuries like pelvic fractures, etc. and

also the inflammation present in the urethra at the time of injury settles

down.

After understanding the enormous amount of excellence and expertise

spent to treat stricture urethra one can simply divide management of

stricture urethra into three groups:-

63
1. Regeneration, dilatation, optical internal urethrotomy

2. Excision and anastomosis, anastomosing urethroplasty

3. Substitution urethroplasty, vascularized flaps, prepuce grafts –

buccal mucosa, plain flap, bladder mucosa.

Regeneration Procedure

Regeneration procedure depends upon completion of part of the

circumference of the urethral lining by generative proliferation of

urothelium. The long-term success and urethral dilatation and of internal

urethrostomy is entirely dependent upon this and the result depends upon

whether epithelialization can occur before restenosis develops.

This principle of Dennis Brown buried strip procedure is to induce

apposition regeneration and thus completion of epithelial lining of

neourethra. However, although this is a fundamental principle as a back-

up procedure in reconstructive surgery, it is no longer advocated as a

primary procedure for urethral reconstruction.91

Excision and Reanastomosis

The only stricture resolving procedure with and expected long-term

success rate approximately 100% is excision and spatulated tension free

circumferential anastomosis. Unfortunately, owing to the extent of the

64
spongiofibrosis that is commonly associated with stricture of the bulbar

urethra few are appropriate for resolution in the way.

Substitution of urethra

All epithelial substitutes and all individual techniques for their use

have inherent shortcomings with an inevitable incidence of failure. No

substitution for the urethra is any good as the urethra itself, some are

much better than others, but all have inherent shortcomings and

consequently a commensurate incidence of restenosis.

Tissue transfer technique:

 Full thickness skin grafts

 Split thickness skin grafts

 Buccal mucosal graft

 lateral mucosal tongue graft (Simonato et al)

 Bladder mucosal graft

 Meshed graft urethroplasty

 Human amnion membranes (grafts) (Koziak et al)

 Pedicle skin flaps (Blandi’s Procedure, Orandi’s Procedure,

perineal skin flap)

 Skin island onlay flap

65
 Skin island tabularized flap

 Hairless scrotal, island flap

None of these methods is adequate in extensive inflammatory strictures.

VARIOUS TREATMENT MODALITIES

I. Dilatation:

General principle of urethral dilatation is soft and gentle stretching

of the scar without producing more scarring. If bleeding occurs during

dilatation, it indicates that stricture has been torn which is likely to

produce more scarring; hence to be avoided. Urethral balloon dilatation is

quite safe. Long term success is poor and recurrence rate is high. Once

the repeat dilatation is discontinued, the stricture will recur.

Clean intermittent self-catheterization is an effective and safe way of

managing recurrent urethral strictures.

II. Optical Internal Urethrotomy:

This is a procedure that opens the stricture by incising it

transurethrally. It involves incision through the scar to healthy tissue to

allow the scar to expand and the lumen to heal enlarged. The goal of

internal urethrotomy is to have epithelial regrowth before scar recurs in

the same area. If epithelialization progresses completely before wound

66
contraction significantly narrows the lumen, the internal urethrotomy may

be a success.

If wound contraction significantly narrows the lumen before

completion of epithelialization, the stricture has recurred.

A single incision at 12 O’ clock position is made following which a

catheter is inserted which is removed after 3 to 5 days. Urethrotomy is

potentially curative for short strictures (less than 1 cm) that are not having

significant spongiofibrosis.

After each successive urethrotomy, there is a period of fleeting

good urinary flow followed by a worsened degree of spongiofibrosis and

lingering stricture. Short term success rate is 70 – 80 % (6 months). By 5

years the recurrence rate approaches 80%.

III. Urethral Stenting:

Both removable stents and permanently implantable stents are

available. Stents are inserted after internal urethrotomy or dilatation.

Removable stents are left in place from 6 months to 1 year and prevent

epithelialization from incorporating the stents into urethral wall.

Memokath (made of Nitinol) is currently in practice. Urolume (made of

an alloy) is currently available permanent stent. Once in place, it gets

incorporated into the wall of the urethra and corpus spongiosum. It is

67
ideal for short stricture of bulbar urethra with minimal spongiofibrosis.

Overall success rate is less than 30% over 10 years.

Permanent stents are contraindicated in patients with prior

substitution urethroplasty especially when skin has been used as its

insertion is associated with virulent hypertrophic reaction. Patients with

distraction injuries and straddle injuries with deep spongiofibrosis are

also not suitable candidates. These stents are preferably used in older

patients of more than 50 years and in patients who are unfit for surgical

procedures.

IV. Open Surgical Urethral Reconstruction (Urethroplasty):

Many different reconstructive procedures have been used to treat

strictures, some of which require one or two operations, in all cases, the

choice of repair is influenced by the characteristics of the stricture and no

single repair is appropriate for all situations. Open reconstruction of a

urethral stricture may involve surgery to remove the stricture and

reconnect the two ends (anastomotic urethroplasty). When the stricture is

too long and this repair is not possible, tissue can be transferred to enlarge

the segment to normal (substitution procedures). Substitution repairs may

need to be performed in stages in difficult circumstances.

68
PRINCIPLES OF URETHROPLASTY

 Anatomical principle relates primarily to the elasticity of urethra.

 Excision and anastomosis is possible proximal to suspensory

ligament of the penis or the distal margin of bulbospongiosus

muscle but is contraindicated distal to that point for fear of

interfering with erection.

 Achieving urethral length.

 Mobilization of urethra.

 Division of suspensory ligament.

 Reducing the inferior pubic angle.

 Rerouting of urethra.

Urethroplasty outcomes

Urethral stricture disease is a common and recurring condition that

affects many men. Urethral stricture disease causes both social and

financial hardships, with frequent procedures, lost wages, anxiety, and

social disengagement when severe. The morbidity of male urethral

stricture arises from urinary tract obstruction and can include LUTS,

recurrent urinary tract infection, sexual dysfunction and more rarely

chronic bladder dysfunction, kidney damage or Fournier gangrene. 92,93

69
Treatment of urethral stricture largely aims to eliminate obstruction and

alleviate LUTS94. The disease incidence increases over time.92 The high

complexity drives referral to dedicated reconstructive surgeons for

optimal patient outcomes. The past 2 decades have seen improvements in

surgical techniques, with a renewed interest in substitution urethroplasty

correlating with improved outcomes for long, complex strictures not

amenable to anastomotic repair. In the bulbar urethra, many variables,

such as length, severity, and location of stricture, can influence surgical

outcome. The surgical technique should be selected mainly according to

stricture length, but the stricture etiology and density of the

spongiofibrosis tissue should also be taken into account.95 Although the

success rate of bulbar urethroplasty is high, some argued that this is the

urologist’s view and not necessarily the patient’s view.96 Whereas the

urologist concentrates on voiding efficiency, the patient is much more

concerned with cosmetic effects and adverse effects, especially on sexual

performance.97 The motivating factor for many urethroplasties is QOL;

thus, assessing patient satisfaction after reconstruction is critical for

patient counseling.96,97

70
OUTCOME MEASURES

Interventions targeting urethral strictures aim to improve symptoms

and reduce risk of recurrence. Their success should be measured in

transparent and transferable terms that testify to the benefit conferred to

an individual patient and allow comparisons of clinical and cost

effectiveness between surgeons, competing surgical procedures, and

health care providers.99 Recurrence rate, Qmax, and urethrography are the

established clinician-orientated measures, but a validated tool designed to

measure patient reported benefit from urethral stricture surgery is a recent

concept. Most studies to date have largely been descriptive, focused on a

particular surgical technique, and limited by subjective physician-

reported outcomes. Little has been published using objective data and/or

patient-perceived symptom and quality of life outcomes after

urethroplasty, although the importance of patient-reported outcomes has

recently gained momentum.96,97 Evaluation can involve any combination

of cystourethroscopy, flow studies, retrograde urethrography or other

imaging studies, and patient history.94,100 A minimum of 17Fr as the

standard objective is defined as success by many. However, the static

retrograde urethrography image can both underestimate (by as much as

50%) and overestimate the length of the stricture.101 Intra operative

urethrocystoscopy can be used as an adjunct to retrograde urethrography

71
to estimate the extent of stricture.102 Tools used for patient-reported

outcomes to better describe patients’ perception of success are, the

urinary bother scores, quality of life, and overall erectile function.

Patients’ perception of success also correlates with the objective

outcomes. These measures will become increasingly important in the

modern healthcare environment to justify our management and

effectiveness, not only to potential patients but also to paying providers.

Only after acquiring and analyzing objective data can we better

understand our outcomes. This knowledge will lead to improved

treatment strategies and, ultimately, superior patient care. Various

investigators have evaluated the use of the AUASI or FRs to determine

the success of urethroplasty98,103-107. These studies have largely

considered one aspect of a successful outcome in isolation. Patients are

concerned with all these aspects and with the ability to freely empty their

bladder, indicating the need to analyze all these domains concomitantly.

72
PATIENT-REPORTED OUTCOME MEASURES

Patient-reported outcome measures (PROMs) are health

questionnaires that patients complete before and after an intervention to

determine whether their symptoms or health-related quality of life

(HRQoL) have changed.108,109 PROMs indicate patient-perceived benefit

from surgery and are necessary for preoperative patient counselling,

performance evaluation, and resource allocation.110 Surgical

interventions, including urethral dilatation, endoscopic urethrotomy, and

urethroplasty, aim to return patients to a state of normal voiding. A recent

Cochrane review111 identified only two direct comparative studies of

these options, both of which employed clinician-driven outcome

measures such as time to recurrence or change in maximum flow rate

(Qmax) to gauge success. A robust PROM allows urologic surgeons to

measure directly the benefit that patients derive from their interventions

and facilitate comparative studies of effectiveness. Voiding,

postmicturition, and storage lower urinary tract symptoms (LUTS);

sexual and ejaculatory function; and symptom-specific and generic

HRQoL measures are commonly used in questionnaires. A more disease-

specific questionnaire would provide more sensitivity and specificity in

evaluating urethral reconstruction outcomes. Patients and clinicians agree

that questions targeting storage LUTS are not of specific importance in

73
describing the expected benefits of urethral stricture treatment. Similarly,

questions relating to sexual function are insensitive to change owing to a

low baseline incidence and lack of deterioration following urethroplasty.

Morey et al first reported that urethral stricture was associated with

severe bother scores on AUASI and the questionnaire successfully

predicted the therapeutic outcome after urethroplasty.107 Similarly, Heyns

and Marais observed that AUASI combined with uroflowmetry could

possibly predict recurrent stricture after endoscopic intervention or

urethroplasty.98 Although IPSS/ AUASI were initially designed and

validated to assess treatment for BPH, it can be used to evaluate other

causes of lower urinary tract obstruction. In general, the AUASI is a

validated instrument with internal consistency and test–retest correlation

(reliability) that provides a quantitative estimate of subjective voiding

symptoms. Although it was not specifically validated for urethral

stricture, studies show that AUASI may be an effective way to evaluate

outcomes in men undergoing urethral stricture incision, dilation or

urethroplasty.98,107 A significant inverse correlation between the urethral

diameter and the AUASI has been reported.98,104 Men with urethral

stricture have symptoms that are not captured by the questionnaire. 96,112

AUASI , introduced in 1992, is a patient related questionnaire designed to

evaluate men with BPH related LUTS.113 Although it lacks specificity for

74
BPH, it is a valid way to characterize LUTS severity and treatment

outcomes in men with BPH.114-116 In an American retrospective review,

21% presented exclusively with voiding symptoms not included on

AUASI. The most common presenting voiding symptoms not captured by

AUASI were urinary stream spraying in 13% of cases and dysuria in

10%. Urinary symptoms are largely heterogeneous and vary in terms of

stricture etiology and site. In an American study117 although patients with

urethral stricture due to lichen sclerosis were more likely to present with

obstructive symptoms and less likely to present in urinary retention, no

other significant difference in the type of voiding symptoms based on

stricture etiology was found. With respect to site only men with penile

urethral stricture were more likely to presents with symptoms outside

AUASI, namely urinary stream spraying. Overall the authors suggest that

symptoms cannot predict stricture site or etiology, consistent with

previous reports.107

75
AUASI: - American Urological Association Symptom Index

NOW ALSO KNOWN AS

IPSS: - International Prostate Symptom Score

76
Literature suggests including relevant non AUASI voiding symptoms in

future questionnaires, such as dysuria and urinary stream spraying, which

are prevalent in stricture cohorts. However, incorporating these types of

voiding symptoms should be based on patient focus groups and individual

interviews across multiple institutions, in addition to single center studies

and existing meta-analyses.117

A Belgian study118 shows a significant amelioration of the

postoperative IPSS score suggesting that the reconstruction of a normal

urethral diameter is responsible for this. Comparing the patients with a

recurrence versus the other patients, there was a higher 6 weeks and 6

months IPSS in the patients with a recurrence. This suggests that a high

IPSS might be a predictor of stricture recurrence. This was also observed

in other studies using the AUASI98,104 : a persistent high symptom score

correlated well with a recurrent stricture. The drawback of the use of both

maximum urinary flow and IPSS is the lack of specificity for recurrence

of urethral stricture disease.119 Other factors affecting the lower urinary

tract such as BPH, dysfunctional voiding and neurogenic bladder can also

explain a persistent low Qmax and high IPSS. Nevertheless, rapid

deterioration of Qmax and IPSS, especially in young and otherwise

healthy patients should be considered as a sign of stricture recurrence and

justifies further and more invasive examinations such as urethroscopy and

77
urethrography. It was recently reported that to detect stricture recurrence,

a 2-tier approach seems to be the most frequently used.94 This strategy

consists of a non-invasive screening method in the first tier, followed by

more invasive tests (e.g. urethrography or urethroscopy) if the first tier is

suspicious for stricture recurrence. In the first tier, questionnaires about

urinary symptoms (IPSS or AUASI) and uroflowmetry were often used.

AUA scores fall markedly after surgery, which correlates with Qmax and

urethrographic appearance indicating criterion validity and sensitivity to

change.107 A study reported good correlation between total AUA scores

and Qmax as preoperative measures of disease severity.98 Kessler et al

provided further evidence of the need for a urethral stricture surgery

PROM in 2002 by reporting clear discordance between clinician- and

patient reported success in 20% of 267 men following urethroplasty. 97

This study lacks preoperative data, however, and men were surveyed at

varying intervals after surgery.

The relative improvement in the AUASI is not diminished by the

lesser improvement in Flow Rates; thus, older patients can expect

significant improvements in the AUASS and QOL score after

urethroplasty.120 Overall, patients can expect to experience a median

improvement of 11 points in the AUASS and 4 points in the QOL score

after urethral reconstruction. This correlated with a FR improvement of

78
12 mL/s overall, with patients <45 years experiencing a greater increase.

The youngest had the greatest improvement (P <.05), with a trend toward

increasing age resulting in less improvement in the FR.120

An urethral surgery PROM comprising a LUTS construct

consisting of six summative questions is used in European centres.99 It is

derived from the International Consultation on Incontinence

Questionnaire Male Lower Urinary Tract Symptoms (ICIQMLUTS)

module121,122 a LUTS-specific quality-of-life (QoL) question; and

Peeling’s voiding picture.123 The EQ-5D124 was included to assess overall

HRQoL, supplemented with two further questions addressing overall

patient satisfaction. The tool is statistically valid and reliable according to

established psychometric criteria as responsiveness to change,

acceptability to patients, content and criterion validity, test-retest

reliability, and internal consistency. However, it does not query the effect

on erectile dysfunction or confirm patency with an objective measure;

still, it’s universal adoption for follow-up of patients with urethral

stricture could be very beneficial to the field.117

79
PEELING VOIDING PICTURE

SEXUAL FUNCTION

For decades, urethral surgeons haven’t paid much attention to

erectile function after urethroplasty except in case of pelvic fracture

related urethral injuries.125,126 Coursey et al were the first to ascertain the

effect of anterior urethroplasty on erectile function;127 they were able to

detect a significant transient decline in erectile function, but only for long

urethral strictures. Different techniques for anterior urethroplasty may

involve aggressive urethral dissection extending from high in the

bulbomembranous urethra to sometimes beyond the suspensory ligament.

This may theoretically adversely affect the erectile function as the

80
dissection of the urethra in the intercrural space is potentially more likely

to expose erectile nerves to risk since these nerves must leave the safety

of the dorsal surface of the corporeal bodies to enter the pelvis lateral to

the membranous urethra behind the symphysis. But there appears to be

little anatomical basis, for severe erectile dysfunction, after anterior

urethral reconstruction. According to Lue et al128 some cavernous fibers

pass through the tunica albuginea to supply the corpus spongiosum but

most cavernous fibers remain approximately 3 mm outside of the corpus

spongiosum at the 1 and 11 o'clock positions. The impact of such surgery

on potency has rarely been documented in Indian patients. Indian men

aged 50-59 and 60-69 years, have low level of sexual drive (SD) and

erectile function (EF) domain score preoperatively as well as

postoperatively129 as compared to normative levels for community-based

men aged 50-59 and 60-69 years established by O'Leary et al.130 This

study from SGPGI, India found that different types of anterior

urethroplasties whether associated with short or long strictures did not

influence postoperative outcome with respect to EF. When simply

comparing scores before and after surgery, there were no significant

changes in SD and EF scores. Although 21% patients reported lower

absolute value of EF scores, the decrease was not statistically significant

for different age groups as well as for this cohort as a whole. Similar

findings are reported in a retrospective mailed questionnaire study of 152

81
men by Coursey et al127 showing that anterior urethroplasty was no more

likely to cause long-term postoperative sexual dysfunction than

circumcision. Using the O'Leary Brief Male Sexual Function Inventory

for Urology (BMFSI),131

Erickson et al132 found that only men 50 to 59 years old, compared to

younger men, had decreased EF after surgery.

Jennifer et al133 did a prospective study on a cohort of 25 patients and

found that surgical complexity with long stricture excision and the use of

a buccal graft did not influence postoperative outcome with respect to EF.

Sexual dysfunction is associated with urethral stricture and validated

questionnaires such as the International Index of Erectile Function can

assess erectile and ejaculatory function in men before and after

urethroplasty.127,133-137 A significant decline in the IIEF, is defined in

reported studies as a change of 5 points.137,138 Additional factors

contributing to erectile dysfunction may go unrecognised. No correlation

was found with procedure type: onlay, flap, second-stage procedure in a

study, where no patients who underwent anastomotic urethroplasty

experienced a decline in erectile function.120 The published data have

varied regarding erectile function outcomes after urethroplasty, with

some studies suggesting a greater incidence depending on the approach or

etiology.

82
Nuss et al report overall sexual dysfunction rate of 11%.117 Men with

urethral stricture due to failed hypospadias repair or lichen sclerosis were

more likely to have sexual dysfunction in this cohort. Of note in a

study,120 16 patients experienced significant improvement in erectile

function after urethral reconstruction (>5 points), 7 of whom were >45

years old. Authors believed this might have resulted from the overall

improvement in QOL after successful urethroplasty correlating with

increased psychological well-being. The anxiety and mental burden some

patients experience from severe urethral stricture disease can affect daily

life and the physiologic aspects of erectile function. Such improvements

have not been previously defined in published studies of anterior urethral

stricture disease. Recently, 2 prospective studies have been published

using the IIEF to assess erectile function after urethroplasty. These

studies of Erickson137 (52 patients) and Xie135 (125 patients) came to

similar conclusions: about 40% reported diminished erectile function

post-operatively with recovery in most patients after 6 months. These

studies also showed that bulbar and especially anastomotic repair appears

to have a greater effect on erectile function. Recently reported data could

be particularly helpful when counseling patients preoperatively, as worry

over future erectile function is often a concern for patients undergoing

procedures to improve their QOL.

83
 The overall ejaculatory function (EjF) score has been shown to be

significantly increased after surgery for all ages (P < 0.001), except 50-59

and 60-69 years age group.129 Multivariate analysis showed that neither

the type of stricture repair nor the length of stricture significantly altered

overall EF, SD or EjF. As proposed by Erickson et al the improvement in

mean EjF score may be due to the relief of the urethral obstruction, and

resection of the acontractile, scarred segment of the urethra/spongiosum

which improves the rhythmic expulsion mechanism by re-establishing the

continuity of the musculature. In a korean series, 2 patients complained of

decreases in ejaculatory force and volume.139 Barbagli et al140 reported

that 23.3% of patients had postoperative ejaculation disorder. The most

frequent postoperative ejaculation disorder was decreased force of

ejaculation (20%) or semen sequestration in the urethral bulb (3.3%). 87

Yucel and Baskin141 suggested that most likely surgical damage to the

branches of the perineal nerves or bulbospongiosus muscles may have a

role in determining the loss of efficient bulbar urethral contraction, thus

causing difficulties in expelling semen and urine.

84
85
FLOW RATE

In a study120 the overall improvement in the FR was a median of

12mL/s, but the mean volume voided of 150 mL, was not a strict

criterion, and some men had lower voided volumes, perhaps contributing

to the more modest FR improvement compared with that in other

series.105,106 FR is the only parameter for which the authors noted a

difference between the younger and older patients, with older patients

experiencing a more moderate, although still statistically significant,

improvement. Because urinary FRs typically decline with age, this

finding was not unexpected, highlighting the importance of preoperative

and postoperative data using the patient as his own control. One report

that found FR alone to be a helpful data point, with high specificity and

sensitivity, only had an inclusion rate of 31%, making any conclusions

difficult to determine.105 In addition, if the average stricture length is

longer, it indicates a more complex repair that is often associated with a

lower FR despite patency. The important data point to monitor

postoperatively once the urethroscopic evaluation has determined patency

is any change in the FR and symptom score from an established baseline.

Furthermore; specifically analyzing the shape of the curve for FR, might

also prove valuable. In a Belgian118 study, a significant amelioration of

Qmax was observed 6 months after urethroplasty. Moreover, successful

86
cases had a significant better Qmax compared to the failures. These

findings suggest that uroflowmetry is a useful examination in the follow-

up of patients after urethroplasty. A significant positive correlation

between Qmax and urethral diameter has been reported by Heyns and

Marais.98

87
CYSTOSCOPY

The AUASS and QOL questionnaires alone can be confounded by

presence of benign prostatic hyperplasia and other lower urinary tract

pathologic entities. Initially created and validated to assess patients with

benign prostatic hyperplasia, both have been used to address urethral

stricture disease.104,113 Data from a study120 reveals that symptom scores

and QOL improvement are meaningful, but not specific enough to detect

successful reconstruction alone. As found in the study, some patients with

a FR of <15 mL/s or a moderate AUASS (30%) had a widely patent

urethra.

Many patients have concurrent lower urinary tract symptoms that

cannot be accurately assessed by symptom scores or FRs, as has been

noted in other series.105,106 Others have noted a modest improvement in

QOL because of postoperative dribbling secondary to a long buccal graft,

despite a patent urethra. These various other lower urinary tract

symptoms can mask whether urethroplasty created a successfully patent

urethra. Cystoscopy has been used as an adjunct to the patient reported

outcomes and uroflow parameters to provide an objective measurement

of success. A single cystoscopy at 6-12 months postoperatively serves as

a reliable, reproducible data point for comparison to which the concurrent

symptom scores, FR, and PVR can be matched. Follow-up cystoscopy at

88
6th month also allows early intervention before healing has completed; 9-

12 months might also be appropriate.

PATIENT SATISFACTION

Most patients feel satisfied with the surgical outcome despite some

minor postoperative complications.140 In a korean series,139 the most

common complication was intermittent perineal or scrotal pain (24.2%).

Postoperative sequestration of urine in the urethra and diminished tone of

the perineal muscles can lead to (an increase of) postvoid dribbling. 142

Posterior urethroplasty is considered to jeopardize the function of the

external urethral sphincter and might lead to urinary incontinence. All

these possible alterations in urinary and sexual function might have an

impact on the patient’s satisfaction with the procedure. It has previously

been reported that patient’s satisfaction is not always the same as what

the surgeon defines as success.97

STRICTURE RECURRENCE

No unifying presentation for recurrence was found in one study. 120

A decreased FR did not universally correlate with failure; one third of the

patients with luminal narrowing had a FR in the normal range.

Recurrence, noted at an average of 6 months postoperatively, was

discovered in 1 of 6 patients in this series by the scheduled cystoscopy

and was not readily apparent from the questionnaires or FRs. Authors

89
believe that until it is shown that the results of less-invasive tests are

reproducible and accurate, cystoscopy can provide a valuable data point

as a part of a standardized paradigm for follow-up, allowing a common

language to discuss urethral reconstruction. With no universal definition

of success, the outcomes among various techniques, surgeons, or

institutions cannot be determined. The field’s lack of a standard definition

of success is a result of vague, inconsistent follow-up tools. Barbagli et

al140 described a success rate of 90.8% in 153 patients who underwent

bulbar end-to-end anastomosis with a mean follow-up of 68 months. In

2002, Jezior and Schlossberg143 summarized the surgical outcomes of

excision and primary anastomosis for bulbar stricture on the basis of

major series reported in the literature. These series showed a success rate

of 93% in 443 patients with a range of 65% to 100% between series. The

literature suggests that the influence of previous treatment on surgical

outcome is controversial.102,140,144-146 Local ischemia, excessive tension at

the anastomosis, advanced age, previous surgery, heavy smoking and

certain co-morbidities are risk factors for poor vascular status and

outcomes. Fortunately, in most cases of anastomotic surgery this fibrosis

is mild and failures can be “rescued” with a single optical urethrotomy,

taking the final success rate close to 100%.145,147,148

90
FOLLOW-UP STRATEGY

A recent systematic review has highlighted the need to add

objective data to urethral reconstruction outcomes. The investigators

found an average of 3.15 procedures (range 1-8), including

questionnaires, being used to follow-up patients after urethroplasty.94 Of

the reports reviewed, 47% used patient history and questionnaires to

screen for recurrence, and 56% used uroflowmetry. Also among the most

common measures were retrograde urethrography (51%) and cystoscopy

(46%). None stated a clear definition of success. Stricture recurrence was

documented by the need for urethral dilation in 53% of the studies, and

need for endoscopic or surgical revision was documented as recurrence in

77%. A standardized method that accounts for both objective data

(urethroscopy and urinary flow parameters) and patient-reported

outcomes is needed to substantiate results. It is clear that no single FR

value or symptom score will be able to determine whether urethral

reconstruction was successful. Using patient reported questionnaires and

flexible cystoscopy (17Fr), which is painless, quick, and easily done in

clinic, will allow a standard platform to discuss the outcomes of urethral

reconstruction. The way forward in assessing urethroplasty outcomes,

seems to involve PROMs as an integral part; and this should enhance our

efforts towards better patient-care for stricture cases.

91
VARIOUS RELATED STUDIES

Nelson CP et al.149 (2005) conducted a study to evaluate genitourinary

function and satisfaction after oral mucosa graft urethroplasty (OMGU)

for hypospadias. They identified 65 patients who had undergone OMGU.

Located 51 patients who had undergone OMGU, of whom 43 (84%)

agreed to participate in the study. Median follow up was 6.9 years. Mean

study age was 15.1 years. Of the patients 47% had severe hypospadias

with failed previous repair and 42% had severe hypospadias with

previous first stage surgery. Oral complaints were rare and primarily

cosmetic. No patient whose oral harvest was limited to the cheek (vs lip)

had cosmetic complaints. Urinary spray and stream deviation were

reported by 11 patients (26%) and 12 patients (28%), respectively.

American Urological Association symptom scores were generally low

(mean 5.66.0, range 0 to 21) but 7 patients (16%) had moderate

symptoms and 2 (5%) had severe symptoms. Of the patients 60% were

mostly satisfied or better with urinary function. Although satisfaction

with penile appearance varied (51% of patients were satisfied), most

patients (84%) were satisfied with the overall hypospadias care. Urinary

symptom scores were significantly worse among patients who had post-

OMGU complications (p = 0.004). Of these patients 38% had moderate

or severe urinary symptoms, while 95% of patients without complications

92
had mild symptoms (p = 0.01). Many patients report good long-term

outcomes of OMGU, although a subset of patients has significant urinary

and cosmetic complaints that are more prevalent in association with

surgical complications.

Lumen N et al.150 (2011) A prospective analysis was done in 21

patients who underwent urethroplasty. An assessment of the urinary flow,

urinary symptoms (International Prostate Symptom Score <IPSS>),

erectile function (International Index of Erectile Function-5 <IIEF-5>)

and urinary continence (International Consultation Committee on

Incontinence Questionnaire male Short Form <ICI-Q-SF>) was done

before urethroplasty and 6 weeks and 6 months after urethroplasty.

Patients were also asked to score their satisfaction with the urethroplasty

after 6 weeks and 6 months. Mean patient’s age was 48 years (range: 26-

80 years). Mean stricture length was 4.2 cm (range: 1-12 cm). Three

patients suffered a stricture recurrence. Mean maximum urinary flow

increased from 5.83 mL/s to 24.92 mL/s (p < 0.001). Mean IPSS

preoperative, 6 weeks and 6 months postoperative was respectively 15.86,

4.60 and 6.41(p <0.001). The mean IIEF-5 score preoperative, 6 weeks

and 6 months postoperative was respectively 15, 12.13 and 11.62 (not

significant). The mean ICI-Q-SF score preoperative, 6 weeks and 6

months postoperative was respectively 10.47, 8.33 (p = 0.04) and 9.47 (p

93
= 0.31). Patient’s satisfaction 6 weeks and 6 months postoperative was

respectively 17.14/20 and 17.12/20. They concluded that that

urethroplasty leads to a significant improvement in urinary flow and IPSS

and urinary continence is tending to improve. Although not significant,

erectile function was slightly diminished after urethroplasty. Functional

outcome should be assessed when urethroplasty is performed.

DeLong J et al.151 (2013) conducted a study to report patients’

perceptions of urethral reconstruction outcomes by comparing the results

from preoperative and postoperative symptom questionnaires and to

propose a standardized method of follow-up that includes patient

satisfaction questionnaires and objective cystoscopic evaluation to

facilitate comparison of different urethral reconstructive techniques and

outcomes among surgeons and institutions. Data were prospectively

collected for 110 consecutive patients undergoing urethral reconstruction.

The mean patient age was 47 years, and the mean stricture length was 4.9

cm. Of the 110 patients, 32 received anastomotic (29%), 60 onlay (55%),

7 staged (6%), and 11 fasciocutaneous flap (10%) urethroplasty. The

median individual change comparing the pre- and postoperative data was

an improvement of 11 for the American Urological Association Symptom

Score (P <.0001), 4 for the quality of life score (P <.0001), and 0 for

International Index of Erectile Function (P ¼ .05). No unifying individual

94
follow-up questionnaire or flow rate correlated with recurrence. They

concluded that, patients undergoing urethral reconstruction reported

significant improvement in urinary bother and quality of life scores while

maintaining or improving their erectile function. Cystoscopic evaluation

can be a valuable component of the postoperative follow-up algorithm,

providing a consistent data point for comparison and confirming the

patency of repair. Standardization of the measured outcomes is critical to

validate the reported urethral reconstructive outcomes.

Jackson MJ et al.152 (2013) conducted a study to evaluate urethral

reconstruction from the patients’ perspective using a validated patient-

reported outcome measure (PROM). Forty-six men with anterior urethral

stricture at four UK urology centres completed the PROM before

(baseline) and 2 yr after urethroplasty. Thirty-eight men underwent

urethroplasty for bulbar stricture and eight for penile stricture. The

median (range) follow-up was 25 (20–30) mo. Total LUTS scores (0 =

least symptomatic, 24 = most symptomatic) improved from a median of

12 at baseline to 4 at 2 yr (mean [95% confidence interval (CI)] of

differences 6.6 [4.2–9.1], p < 0.0001). A total of 33 men (72%) felt their

urinary symptoms interfered less with their overall quality of life, 8

(17%) reported no change, and 5 (11%) were worse 2 yr after

urethroplasty. Overall, 40 men (87%) remained ‘‘satisfied’’ or ‘‘very

95
satisfied’’ with the outcome of their operation. Health status visual

analogue scale scores (100 = best imaginable health, 0 = worst) 2 yr after

urethroplasty improved from a mean of 69 at baseline to 79 (mean [95%

CI] of differences 10 [2–18], p = 0.018). Health state index scores (1 =

full health, 0 = dead) improved from 0.79 at baseline to 0.89 at 2 yr

(mean [95% CI] of differences 0.10 [0.02–0.18), p = 0.012]). This is the

first study to prospectively evaluate urethral reconstruction using a

validated PROM. Men reported continued relief from symptoms with

related improvements in overall health status 2 yr after urethroplasty.

These data can be used as a provisional reference point against which

urethral surgeons can benchmark their performance.

Bertrand LA et al.153 (2016) Men 18 years old or older with

urethral strictures undergoing urethroplasty were prospectively enrolled

in a longitudinal, multi-institutional urethroplasty outcomes database.

Preoperative and postoperative assessment included questionnaires to

assess lower urinary tract symptoms, pain, satisfaction and sexual health.

Analyses controlling for stricture recurrence (defined as the inability to

traverse the reconstructed urethra with a flexible cystoscope) were

performed to determine independent predictors of dissatisfaction. At a

mean followup of 14 months we found a high 89.4% rate of overall

postoperative satisfaction in 433 patients and a high 82.8% rate in those

96
who would have chosen the operation again. Men with cystoscopic

recurrence were more likely to report dissatisfaction (OR 4.96, 95% CI

2.07–11.90) and men reporting dissatisfaction had significantly worse

uroflowmetry measures (each p <0.02). When controlling for recurrence,

multivariate analysis revealed that urethra and bladder pain (OR 1.71,

95% CI 1.05–2.77 and OR 2.74, 95% CI 1.12–6.69, respectively), a

postoperative decrease in sexual activity (OR 4.36, 95% CI 2.07–11.90)

and persistent lower urinary tract symptoms (eg straining to urinate OR

3.23, 1.74-6.01) were independent predictors of dissatisfaction. Overall

satisfaction after anterior urethroplasty is high and traditional measures of

surgical success strongly correlate with satisfaction. However,

independently of the anatomical appearance of the reconstructed urethra,

postoperative pain, sexual dysfunction and persistent lower urinary tract

symptoms were predictors of patient dissatisfaction.

Lucas ET et al.154 (2017) they prospectively collected data from

35 consecutive patients who underwent urethroplasty. Patient

demographics, International Prostate Symptom Score (IPSS), quality of

life score, urethral stricture surgery patient-reported outcome measure

(USS-PROM), maximum flow rate (Qmax) and post-void residual urine

were collected before, two and eight months after surgery. Failure

occurred when any postoperative instrumentation was performed. General

97
estimation equation was used to compare the results and linear regression

analysis to correlate both questionnaires with objective data. Mean age

was 61 years. Urethroplasties were equally divided between anastomotic

and buccal mucosa grafts and 19 patients (59.3%) had a previous urethral

procedure. Overall success rate was 87.5%. IPSS improved from a mean

19 at baseline to 5.32 at 8 months (p <0.001). The mean USS-PROM

score also improved from 13.21 preoperatively to 3.36 after surgery (p

<0.001) and 84.3% of patients were satisfied or very satisfied with

surgical results. Mean Qmax increased from 4.64mL/s to 11mL/s (p

<0.001). Strong negative correlation was found respectively between flow

rate and USS-PROM (r=-0.531, p <0.001) and with IPSS (r=-0.512, p

<0.001). They concluded that significant improvements in urinary

symptoms and in quality of life are expected after urethroplasty and they

are correlated with objective measures.

Horiguchi A et al.155 (2018) conducted a study to better

understand urethroplasty outcome and used it to evaluate the effect of

urethroplasty for anterior urethral strictures. The PROM quantifies lower

urinary tract symptoms (LUTS) and health-related quality of life (EQ-

5D), and it evaluates overall satisfaction by asking patients to choose

“very satisfied”, “satisfied”, “unsatisfied”, or “very unsatisfied”. 93

Japanese-speaking male patients with anterior urethral stricture who

98
underwent urethroplasty completed it before (baseline) and 6 months

after urethroplasty. Qmax was negatively correlated with the LUTS-total

scores (r=−0.61). Cronbach’s alpha was 0.80 and the test–retest intraclass

correlation coefficient for the LUTS-total score was 0.82. 83 patients

(89.2%) achieved stricture-free, which was defined as no re-stricture on

cystoscopy and no need for additional treatment. The mean total LUTS-

score improved from 12.4 at baseline to 3.7 postoperatively (p < 0.0001).

The mean EQ-5D visual analogue scores and EQ-5D index improved

from 61.2 and 0.76, respectively, at baseline to 77.9 and 0.89

postoperatively (p < 0.0001, p < 0.0001). 55 patients (59.1%) were “very

satisfied” with the outcome of their urethroplasty and 33 (35.5%) were

“satisfied”. They concluded that, the Japanese version of the USS-PROM

has adequate psychometric properties. Urethroplasty improved not only

objective data but also voiding symptoms and health-related QOL, and it

resulted in a high rate of patient satisfaction.

Baradaran N et al.156 (2018) treatment of anterior urethral

stricture disease (urethral stricture disease) has shifted from endoscopic

approaches to urethroplasty with significantly higher success rates among

reconstructive urologists. This academic stance has led to a critical

evaluation of “success” and developing disease-specific instruments to

assess surgical outcomes focusing on patients’ satisfaction rather than the

99
historical goal of avoiding secondary procedures. Many disease non-

specific and/or non-validated patient-reported outcome measures

(PROMs) have been utilized to evaluate the voiding symptoms and sexual

of function of patients after urethroplasty in the literature. Urethral

Stricture Surgery PROM (USS PROM) is the first validated, disease-

specific PROM for anterior urethral stricture disease which has been

designed in 2001. Urethral Stricture Symptoms and Impact Measure

(USSIM) is a comprehensive PROM and is currently being validated at

multiple institutions. This article reviews the tools used to assess success

after urethroplasty and elaborates the need to develop a comprehensive

urethral stricture disease-specific PROM.

Waterloos M et al.157 (2018) conducted a study to report on the

surgical and functional outcome of urethroplasty for UITS and to provide

data on patient reported outcome measures (PROMs). Etiology was

iatrogenic in 5 (27,8%), perineal straddle injury in 6 (33,3%) and pelvic

fracture urethral injury (PFUI) in 7 (38,8%) patients. PFUIs and short

(≤3cm) bulbar strictures were treated by transperineal anastomotic repair

(n=15; 83,3%), whereas a long bulbar stricture and a penile stricture were

treated by respectively a preputial skin graft and flap urethroplasty. A

penetrating penile urethral injury during circumcision underwent early

exploration with primary repair of the laceration. Failure was defined as

100
need for additional urethral instrumentation. PROMs were sent to patients

≥16 years at latest evaluation. Median follow-up is 57 (range: 8-198)

months. No complications, grade 1,2 and 3 complications were present in

respectively 13 (72,2%), 2 (11,1%), 1 (5,6%) and 2 (11,1%) patients.

Success rate in a tertiary referral center was 94,4%. An immediate failure

was observed in a patient with a PFUI and concomitant bladder neck

injury. PROMs were available in 12 patients. Four patients (33,3%)

reported erectile dysfunction. Post-void dribbling (25%) and urgency

(50%) were the most frequently reported complaints. All patients were

satisfied after urethroplasty and stated they would undergo the surgery

again. External trauma is the most important etiology of UITS, but

iatrogenic causes should not be neglected. Urethroplasty, mainly by

anastomotic repair but with the technique adapted to local stricture

characteristics if necessary, has an excellent long-term success rate in

experienced hands. Functional disturbances are frequent but despite this,

patient satisfaction is high after urethroplasty.

101
MATERIAL AND METHODS

102
MATERIAL AND METHODS

The study was conducted in Department of General Surgery Maharaja

Yeshwantrao Holkar Hospital, Indore. The study was conducted

prospectively and on 50 patients presenting with symptoms of urethral

stricture between the time periods from January 2018 to August 2019. It

included both anterior and posterior stricture. A detailed preoperative

assessment along with careful history-taking and physical examination

was carried out and patients were evaluated by means of retrograde

urethrogram, urethrosonogram, and uroflowmetry (pre-operatively

possible only in cases not having SPC).

SAMPLE SIZE

 Minimum number of cases 50.

INCLUSION CRITERIA:

1) Patients with a urethral stricture treated with urethroplasty

2) Patients who give written informed consent.

3) Male patients of 18 years and above.

4) Patients having history of urethral trauma are also included.

103
EXCLUSION CRITERIA:

1) Patients not willing to come up for regular follow-up.

2) Patients not willing to give written consent.

3) Patients taking drugs for erectile dysfunction.

Total 50 patients were taken for urethroplasty after proper consent &

anesthetic fitness. After surgery per urethral silicon catheter was kept for

three weeks in simple strictures and for six weeks in cases of complex

strictures. The functional outcome on urinary and sexual function was

assessed using validated questionnaires that were offered to the patient

before operation and at the 6 weeks and 6 months follow-up visits.

104
THESE QUESTIONNAIRES ARE:

The International Prostate Symptom Score (IPSS) With Quality Of

Life Score

It includes 8 questions (7 symptom questions + 1 quality of life question)

The 7 symptoms questions include feeling of incomplete bladder

emptying, frequency, intermittency, urgency, weak stream, straining and

nocturia, each referring to during the last month, and each involving

assignment of a score from 0 to 5 for a total of maximum 35 points.38 The

8th question of quality of life is assigned a score of 0 to 6.

CUT OFF SCORES

1. MILD 0-7

2. MODERATE 8-19

3. SEVERE 20-35

105
 In the past month Not at Less Less About More than half the Almost always Your

all than 1 than half the time score

in 5 half the time

times time

1.Incomplete 0 1 2 3 4 5

emptying

How often have you

had the sensation of

not emptying your

bladder ?

2. Frequency 0 1 2 3 4 5

How often have you

had to urinate less

than every 2 hrs ?

3.Intermittency 0 1 2 3 4 5

How often have you

found you stopped

and started again

several times when

you urinated ?

4.Urgency 0 1 2 3 4 5

How often have you

found it difficult to

postpone urination ?

5.Weak Stream 0 1 2 3 4 5

How often have you

had a weak urinary

stream ?

6.Straining 0 1 2 3 4 5

How often have you

had to strain to start

urination ?

None 1 time 2times 3 times 4 times 5 Times

106
7.Nocturia 0 1 2 3 4 5

How many times did

you typically get up

at night to urinate ?

TOTAL IPSS

SCORE

Quality of life due to urinary Delighted please Mostly Mixed Most Unhappy Terrible

symptoms d satisfied ly

dissa

tisfie

If you were to spend the rest 0 1 2 3 4 5 6

of your life with your urinary

condition just the way it is

now, how would you feel

about that

107
 International Index of Erectile Function-5 (IIEF-5)

Assessing the patient’s erectile function. Five questions are asked with

5 possible answers leading to a score from 5 (severe erectile

dysfunction) to 25 (normal erectile function).

CUT OFF SCORES

1. SEVERE 5-7

2. MODERATE 8-11

3. MILD TO MODERATE 12-16

4. MILD 17-21

5. NO ED 22-25

108
 QUESTION SCORE TOTAL

1 2 3 4 5

1.hw do you rate Very low Low moderate High Very

your confidence high

that you could

achieve and keep

and erection

2. when you had Almost A few Sometimes(about Most of the Almost

erections with never times(Much half the time) times(much always

sexual stimulation, less than half more than

hoe often were the time) half the time)

your erection hard

enough for

penetration

3.during sexual Almost A few Sometimes(about Most of the Almost

intercourse how never times(Much half the time) times(much always

often were you less than half more than

able yo manintain the time) half the time)

your erection after

you had penetrated

your partner

4. during sexual Extremely Very difficult difficult Slightly Not

intercourse, how difficult difficult diificult

difficult was it to

maintain your

erection to

completion of

intercourse

5. when you Almost A few Sometimes(about Most of the Almost

attempted sexual never times(Much half the time) times(much always

intercourse, how less than half more than

often was it the time) half the time)

satisfactory for you

109
The International Consultation Committee on Incontinence

Questionnaire male Short Form (ICI-Q-SF)

The International Consultation of Incontinence Questionnaire – Short

Form (ICI-Q-SF) is a validated subjective measure of QoL post

urethroplasty surgery . The ICI-Q-SF is formed of six items of which four

main items ask for rating of symptoms in the past 4 weeks. The scores for

items 3, 4 and 5 are taken for the final ICIQ-SF score. Items 1 and 2 are

demographic and the final item is a self-diagnostic item.

CUT OFF SCORES

1.SLIGHT 0-5

2.MODERATE 6-12

3. SEVERE 13-18

4. VERY SEVERE 19-21

QUESTIONNARE

1. Date of birth

2. Sex

3.How often do you leak urine? (Tick one box)

 never 0

 about once a week or less often 1

110
  two or three times a week 2

 about once a day 3

 several times a day 4

 all the time 5

4. We would like to know how much urine you think leaks. How

much urine do you usually leak (whether you wear protection

or not)? (Tick one box)

 none 0

 a small amount 2

 a moderate amount 4

 a large amount 6

5. Overall, how much does leaking urine interfere with your

everyday life?

Please ring a number between 0 (not at all) and 10 (a great deal)

0 1 2 3 4 5 6 7 8 9 10

not at all a great deal

ICIQ score: sum scores 3+4+5

111
6. When does urine leak? (Please tick all that apply to you)

 never – urine does not leak

 leaks before you can get to the toilet

 leaks when you cough or sneeze

 leaks when you are asleep

 leaks when you are physically active/exercising

 leaks when you have finished urinating and are dressed

 leaks for no obvious reason

 leaks all the time

112
USSPROM (Urethral Stricture Surgery Patient Repoted Otcome

Measures)

The USS PROM incorporates LUTS and HRQoL domains, and a

treatment satisfaction question.

The LUTS domain comprises:

1.A six-item additive LUTS construct addressing hesitancy, stream,strain,

intermittency, incomplete emptying, and postmicturition dribble to

generate a total score between 0 (least symptomatic) and 24 (most

symptomatic).

2.Peeling’s voiding picture: an illustration of a man voiding invites

respondents to circle an integer between 1 (best) and 4 (worst)

corresponding to their own flow pattern.

3.A Likert-type LUTS-specific QoL question asks, ‘‘Overall, how much

do your urinary symptoms interfere with your life?’’

HRQoL is assessed by EQ-5D:

1.The EQ visual analogue scale (EQVAS) elicits respondents’ global

health rating on a vertical scale anchored on 100 for ‘‘best imaginable

health state’’ and 0 for ‘‘worst imaginable health state.’’

113
2.The EQ-5D descriptive system generates a health profile encompassing

mobility, self-care, usual activities, pain/discomfort, and anxiety/

depression. Profiles can be summarised to a single EQ-5D index score on

a scale where full health equals 1 and 0 is equivalent to death.

Finally, a global treatment satisfaction question asks respondents whether

are they are satisfied with the outcome of their operation.

QUESTIONNARE

1 Is there a delay before you start to urinate?

Never

Occasionally

Sometimes

Most of the time

All of the time

2 Would you say that the strength of your urinary stream is…

Normal

Occasionally reduced

Sometimes reduced

Reduced most of the time

Reduced all of the time

114
3 Do you have to strain to continue urinating?

Never

Occasionally

Sometimes

Most of the time

All of the time

4 Do you stop and start more than once while you urinate?

Never

Occasionally

Sometimes

Most of the time

All of the time

5 How often do you feel your bladder has not emptied properly after you

have urinated?

Never

Occasionally

Sometimes

Most of the time

All of the time

115
6 How often have you had a slight wetting of your pants a few minutes

after you had finished urinating and had dressed yourself?

Never

Occasionally

Sometimes

Most of the time

All of the time

7 Please ring the number that corresponds with the strength of your

urinary stream over the past month.

116
8 Overall, how much do your urinary symptoms interfere with your life?

Not at all

A little

Somewhat

A lot

117
EQVAS & ED5

118
MOBILITY

I have no problems in walking about

I have slight problems in walking about

I have moderate problems in walking about

I have severe problems in walking about

I am unable to walk about

SELF-CARE

I have no problems washing or dressing myself

I have slight problems washing or dressing myself

I have moderate problems washing or dressing myself

I have severe problems washing or dressing myself

I am unable to wash or dress myself

USUAL ACTIVITIES (e.g. work, study, housework, family or leisure

activities)

I have no problems doing my usual activities

I have slight problems doing my usual activities

I have moderate problems doing my usual activities

I have severe problems doing my usual activities

I am unable to do my usual activities

119
PAIN / DISCOMFORT

I have no pain or discomfort

I have slight pain or discomfort

I have moderate pain or discomfort

I have severe pain or discomfort

I have extreme pain or discomfort

ANXIETY / DEPRESSION

I am not anxious or depressed

I am slightly anxious or depressed

I am moderately anxious or depressed

I am severely anxious or depressed

I am extremely anxious or depressed

120
OBSERVATIONS AND
RESULTS

121
 Observation & Results

Table 1

COMPARISON OF PREOP & POSTOP MEAN VALUE OF

URINARY SCORE AS PER IPSS METHOD

Mean
Time Std. Paired P
Parameter Urinary N Result
Interval Deviation T Test Value
Score
Urinary PREOP 24.700 50 2.765
Score 15.827 0.000 Significant
After 6
[International 15.360 50 6.366
Week
Prostate
Symptom PREOP 24.700 50 2.765
Score After 6 24.215 0.000 Significant
10.200 50 6.411
(IPSS)] Month

Mean Urinary Score

30

25 24.7

20

15 15.36
Mean Urinary Score

10 10.2

0
PRE After 6 Week After 6 Month

122
 Table 2

COMPARISON OF PREOP & POSTOP MEAN VALUE OF

QUALITY OF LIFE SCORE AS PER IPSS METHOD

Mean
Time Std. Paired P
Parameter QoL N Result
Interval Deviation T Test Value
Score
Quality of PRE 4.200 50 1.161
Life Score After 6 13.252 0.000 Significant
International Week 2.560 50 0.884
Prostate PRE 4.200 50 1.161
Symptom
Score After 6 23.125 0.000 Significant
1.980 50 0.958
(IPSS) Month

Mean QoL Score IPSS

4.5
4.2
4

3.5

3
2.56
2.5

Mean QoL Score

2 1.98

1.5

0.5

0
PRE After 6 Week After 6 Month

123
 Table 3

COMPARISON OF PREOP & POSTOP MEAN VALUE OF

INDEX AS PER IIEF-5 METHOD

Mean
Time Std. Paired P
Parameter Index N Result
Interval Deviation T Test Value
(IIEF-5)
PRE 9.420 50 1.214
International 23.426 0.000 Significant
After 6
Index of 17.140 50 3.245
Week
Erectile
Function PRE 9.420 50 1.214
(IIEF-5) After 6 25.212 0.000 Significant
19.640 50 3.901
Month

Mean Index (IIEF-5)

25

20 19.64

17.14

15

Mean Index (IIEF-5)

10
9.42

0
PRE After 6 Week After 6 Month

124
 Table 4

COMPARISON OF PREOP & POSTOP MEAN SCORE AS PER

ICI-Q-SF METHOD

Time Mean Std. Paired P

Parameter N Result
Interval Score Deviation T Test Value
International PRE 16.460 50 1.147
Consultation After 6 19.041 0.000 Significant
Committee 7.540 50 4.092
Week
on PRE 16.460 50 1.147
Incontinence
Questioner
Male Short After 6 23.001 0.000 Significant
6.700 50 3.877
Form Month
(ICI-Q-SF)

Mean Score (ICI-Q-SF)

18
16.46
16

14

12

10

8
6.7 Mean Score (ICI-
6 7.54 Q-SF)

0
PRE After 6 Week After 6 Month

125
 Table 5

COMPARISON OF PREOP & POSTOP MEAN SCORE OF LUTS

DOMAIN IN EQ-5D

Time Mean Std. Paired P

Parameter N Result
Interval Score Deviation T Test Value
PRE 16.600 50 2.138
After 6 4.310 0.000 Significant
15.320 50 3.248
Week
LUTS
PRE 16.600 50 2.138
After 6 20.453 0.000 Significant
7.940 50 4.028
Month
PRE 3.100 50 0.303
After 6 3.855 0.000 Significant
2.780 50 0.582
PEELING Week
PICTURE PRE 3.100 50 0.303
After 6 5.315 0.000 Significant
2.460 50 0.908
Month
PRE 2.720 50 0.454
After 6 15.031 0.000 Significant
1.860 50 0.572
LUTS Week
QOL PRE 2.720 50 0.454
After 6 2.768 0.000 Significant
2.460 50 0.908
Month
PRE 39.740 50 10.154
After 6 12.418 0.000 Significant
53.060 50 13.388
Week
EQVAS
PRE 39.740 50 10.154
After 6 14.532 0.000 Significant
60.660 50 15.458
Month

126
180

160
60.66

140

120

100
53.06 After 6 Month
After 6 Week
80
PRE

60
2.46 2.46
7.94

40 2.78 1.86 39.74

15.32

20 3.1 2.72
16.6

0
Mean Score Luts Mean Score Mean Score Luts Mean Score
PEELING PICTURE QOL EQVAS

127
 Table 6

COMPARISON OF PREOP & POSTOP(6 WEEKS) DIFFICULTY

STATUS OF MOBILITY (HRQoL DOMAIN)

Mobility Pre Duration After 6 Week

P Value
Difficulty Status Frequency Percent Frequency Percent
NO
45 90.0 47 94.0
DIFFICULTY 0.088 Nsig
SLIGHT
5 10.0 3 6.0
DIFFICULTY 0.088 Nsig
Total 50 100.0 50 100.0

Mobility Status

100

90
94
80
90 NO DIFFICULTY
70

60

50
SLIGHT
40 DIFFICULTY

30

20 10 6

10

0
Pre After 6 Week

128
 Table 7

COMPARISON OF PREOP & POSTOP(6 MONTHS)

DIFFICULTY STATUS OF MOBILITY (HRQoL DOMAIN)

Mobility Pre Duration After 6 Month

P Value
Difficulty Status Frequency Percent Frequency Percent

NO DIFFICULTY 45 90.0 49 98.0 0.08nsig

SLIGHT
5 10.0 1 2.0
DIFFICULTY
Total 50 100.0 50 100.0

Difficulty Status For Mobility

98
100 90
90
80
NO DIFFICULTY
70
60
50
40 SLIGHT
30 DIFFICULTY
20 10
10 2

0
% %
Pre Duration After 6 Month

129
 Table 8

COMPARISON OF PREOP & POSTOP(6 WEEKS) DIFFICULTY

STATUS OF SELF CARE (HRQoL DOMAIN)

Self Care Pre Duration After 6 Week

P Value
Difficulty Status Frequency Percent Frequency Percent
NO
45 90.0 47 94.0
DIFFICULTY 0.460 Non Sig
SLIGHT
5 10.0 3 6.0
DIFFICULTY 0.460 Non Sig
Total 50 100.0 50 100.0

Self Care Outcome %

90 94
100
90
80
NO DIFFICULTY
70
60
SLIGHT
50
DIFFICULTY
40
30
20 10 6

10
0
Pre Duration After 6 Week

130
 Table 9

COMPARISON OF PREOP & POSTOP(6 MONTHS)

DIFFICULTY STATUS OF SELF CARE (HRQoL DOMAIN)

Self Care Pre Duration After 6 Month

P Value
Difficulty Status Frequency Percent Frequency Percent

NO DIFFICULTY 45 90.0 48 96.0 0.236nsig

SLIGHT
5 10.0 2 4.0
DIFFICULTY 0.236nsig
Total 50 100.0 50 100.0

Difficulty Status for Self Care

96
100 90
90
80
70 NO DIFFICULTY
60
50
40
30 SLIGHT DIFFICULTY
20 10
4
10
0
% %
Pre Duration After 6 Month

131
 Table 10

COMPARISON OF PREOP & POSTOP(6 WEEKS) DIFFICULTY

STATUS OF USUAL ACTIVITIES (HRQoL DOMAIN)

UA Pre Duration After 6 Week

P Value
Difficulty Status Frequency Percent Frequency Percent
MODERATE
46 92.0 47 94.0
DIFFICULTY 0.695
SEVERE
4 8.0 3 6.0
DIFFICULTY 0.695
50 100.0 50 100.0
Total

UA Outcomes

100
90
80 92 94
70 MODERATE
DIFFICULTY
60
50
40
SEVERE DIFFICULTY
30
8 6
20
10
0
% %
Pre Duration After 6 Week

132
 Table 11

COMPARISON OF PREOP & POSTOP(6 MONTHS)

DIFFICULTY STATUS OF USUAL ACTIVITIES (HRQoL
DOMAIN)

UA Pre Duration After 6 Month

P Value
Difficulty Status Frequency Percent Frequency Percent

MODERATE
46 92.0 48 96.0
DIFFICULTY 0.236
SEVERE
4 8.0 2 4.0
DIFFICULTY 0.236
Total 50 100.0 50 100.0

Difficulty Status of U A

96
92
100
90
80
70 MODERATE
DIFFICULTY
60
50
40
SEVERE DIFFICULTY
30
20 8
4
10
0
% %
Pre Duration After 6 Month

133
 Table 12

COMPARISON OF PREOP & POSTOP(6 WEEKS) STATUS OF

PAIN (HRQoL DOMAIN)

PAIN Pre Duration After 6 Week

P Value
Difficulty
Frequency Percent Frequency Percent
Status
SEVERE
4 8.0 0 0.0
DIFFICULTY 0.037 sig
MODERATE
46 92.0 5 10.0
DIFFICULTY 0.000sig
SLIGHT
0 0.0 33 66.0
DIFFICULTY 0.000sig
NO
0 0.0 12 24.0
DIFFICULTY 0.000sig
Total 50 100.0 50 100.0

PAIN Outcome

92
100 SEVERE DIFFICULTY

80 66
MODERATE
60 DIFFICULTY

40 24 SLIGHT DIFFICULTY

20 8 10
0 0 0 NO DIFFICULTY
0
% %
Pre Duration After 6 Week

134
 Table 13

COMPARISON OF PREOP & POSTOP(6 MONTHS) STATUS OF

PAIN (HRQoL DOMAIN)

PAIN Pre Duration After 6 Month

P Value
Difficulty Status Frequency Percent Frequency Percent

SEVERE
4 8.0 0 0.0
DIFFICULTY 0.037sig
MODERATE
46 92.0 2 4.0
DIFFICULTY 0.000sig
SLIGHT
0 0.0 44 88.0
DIFFICULTY 0.000sig
NO DIFFICULTY 0 0.0 4 8.0
0.000sig
Total 50 100.0 50 100.0

Difficulty Status of Pain

100 100
92 88
100
80
Pre Duration
60 Percent
40
20 8 4 8
0 0 0
0 After 6 Month
SEVERE MODERATE SLIGHT NO Total Percent
DIFFICULTY DIFFICULTY DIFFICULTY DIFFICULTY

135
 Table 14

COMPARISON OF PREOP & POSTOP(6 WEEKS) STATUS OF

DEPRESSION (HRQoL DOMAIN)

Depression Pre Duration After 6 Week

P Value
Difficulty Status Frequency Percent Frequency Percent

SEVERE
3 6.0 2 4.0
DIFFICULTY 0.646 Non Sig
MODERATE
47 94.0 3 6.0
DIFFICULTY 0.00 Sig
SLIGHT
0 0.0 33 66.0
DIFFICULTY 0.00 Sig
NO
0 0.0 12 24.0
DIFFICULTY 0.00 Sig
Total 50 100.0 50 100.0

Difficulty Status For Depression

94
100

80 66
SEVERE DIFFICULTY
60
MODERATE DIFFICULTY
40
24

20 SLIGHT DIFFICULTY
6 4 6
0 0
0
NO DIFFICULTY
% %
Pre Duration After 6 Week

136
 Table 15

COMPARISON OF PREOP & POSTOP(6 MONTHS) STATUS OF

DEPRESSION (HRQoL DOMAIN)

Depression Pre Duration After 6 Month

P Value
Difficulty
Frequency Percent Frequency Percent
Status
SEVERE
3 6.0 0 0.0
DIFFICULTY 0.074nsig
MODERATE
47 94.0 0 0.0
DIFFICULTY 0.00sig
SLIGHT
0 0.0 37 74.0
DIFFICULTY 0.00sig
NO
0 0.0 13 26.0
DIFFICULTY 0.00sig
Total 50 100.0 50 100.0

Difficulty Status of Depression

94
100

74
80 Pre Duration
Percent
60

40 After 6 Week
26 Percent
20 6
0 0 0 0
0
SEVERE MODERATE SLIGHT NO
DIFFICULTY DIFFICULTY DIFFICULTY DIFFICULTY

137
 Table 16

COMPARISON OF PREOP & POSTOP STATUS OF OVERALL

SATISFACTION

After 6 Week After 6 Month

Satisfaction
P Value
Level
Frequency Percent Frequency Percent

Very
0 0.0 5 10.0
Satisfied 0.018
Satisfied 45 90.0 40 80.0
0.157
Unsatisfied 0 0.0 3 6.0
0.074
Very
5 10.0 2 4.0
Unsatisfied 0.236
Total 50 100.0 50 100.0

Patient Satisfaction Status

90
90 80
80
70
60 After 6
Week %
50
After 6
40 Month %
30
20 10 10
6 4
10 0 0
0
Very Satisfied Satisfied Unsatisfied Very Unstaisfied

138
DISCUSSION

139
DISSCUSSION

The variable characteristics of urethral stricture disease and the

wide range of procedures performed to treat it have left the true outcomes

of urethral reconstruction largely unknown. The motivating factor for

many urethroplasties is Quality Of Life(QOL). Assessing patient

satisfaction after reconstruction is critical for patient counseling 137,152.

Earlier, most of the reported success has been based on avoidance of

secondary procedures. Measurements of success from the patient’s

perspective have unfortunately been neglected in urethral reconstruction,

and only recently, collaborative attempts have been initiated at designing

and standardization of patient-reported outcome measures (PROMs) for

urethral reconstruction to determine the success of urethroplasty.The

purpose of the present study was to prospectively analyze the pre and

post-operative patient-reported outcomes measures describing patient’s

satisfaction and QoL after urethral reconstruction with patient serving as

his own control. Interventions targeting urethral strictures aim to improve

symptoms and reduce risk of recurrence. Their success should be

measured in transparent and transferable terms that testify to the benefit

conferred to an individual patient. They should allow comparisons of

clinical and cost effectiveness between surgeons, competing surgical

procedures, and health care providers158.

140
 Patient-reported outcome measures (PROMs) are health

questionnaires that patients complete before and after an intervention to

determine whether their symptoms or health-related quality of life

(HRQoL) have changed.108,109

An urethral surgery PROM comprising a LUTS construct consisting of

six summative questions is used in European centres.99 It is derived from

the International Consultation on Incontinence Questionnaire Male Lower

Urinary Tract Symptoms (ICIQMLUTS) module121,122 a LUTS-specific

quality-of-life (QoL) question; and Peeling’s voiding picture.123 The EQ-

5D124 was included to assess overall HRQoL, supplemented with two

further questions addressing overall patient satisfaction. The tool is

statistically valid and reliable according to established psychometric

criteria as responsiveness to change, acceptability to patients, content and

criterion validity, test-retest reliability, and internal consistency.

PATIENT-REPORTED OUTCOMES

IPSS

It included 8 questions (7 urinary symptom questions + 1 quality of life

question)

While compairing preoperative urinary symptoms with postoperative

urinary symptoms, the difference in Urinary Score between the two

141
intervals of both the pairs at 6 weeks and 6 months was found to be

statistically significant (P˂0.05).

The mean Urinary Score preoperatively was 24.7 which is significantly

higher than that at 6 weeks which was 15.36 and at 6 months which was

10.2 .It implies that the mean Urinary Score as Per IPSS Method differs

significantly on compairing preoperative symptoms with post operative

symptoms of the same patient.

On the other hand While compairing preoperative quality of life with

postoperative quality of life score , the difference in Quality of Life Score

between the two intervals of both the pairs (preop; 6 weeks and preop;6

months ) was found to be statistically significant (P˂0.05).

The mean Quality of Life Score preoperatively was significantly higher at

4.2 compared to 2.56 at 6 weeks and 1.98 at 6 months..

It implies that the mean Quality of Life Score as Per IPSS Method differs

significantly while compairing preoperatve and post operative status of

same patient.

A prospective study done by Lumen N et al.150 in 2011 comprised of 21

patients who underwent urethroplasty. An assessment of the urinary flow,

urinary symptoms was done using International Prostate Symptom Score

IPSS. Mean patient’s age was 48 years (range: 26-80 years). Mean

142
stricture length was 4.2 cm (range: 1-12 cm). Mean IPSS preoperative, 6

weeks and 6 months postoperative was respectively 15.86, 4.60 and

6.41(p <0.001).While Patient’s satisfaction 6 weeks and 6 months

postoperative was respectively 17.14/20 and 17.12/20. They concluded

that that urethroplasty leads to a significant improvement in IPSS and

urinary continence is tending to improve. While in the study of Lucas ET

et al.154 (2017) they prospectively collected data from 35 consecutive

patients who underwent urethroplasty. Patient demographics,

International Prostate Symptom Score (IPSS), quality of life score, were

calculated before, two and eight months after surgery. They observed

IPSS improved from a mean 19 at baseline to 5.32 at 8 months (p

<0.001).

IIEF

While compairing preoperative IIEF score with post opertive IIEF score

at 6 weeks and 6 months time interval , the difference in IIEF between the

two intervals of both the pairs(preop with 6 weeks and pre op with 6

months) was found to be statistically significant (P˂0.05).The mean IIEF

score Preopratively was 9.42 which was significantly low compared to

17.14 and 19.64 at 6 weeks and 6 months respectively.It implies that the

mean value of Index as per IIEF-5 method differs significantly on

143
compairing preoperative score with 6 weeks and 6 months postoperative

IIEF score.

In a prospective study done by Jennifer et al133 on a cohort of 25 patients

and found that surgical complexity with long stricture excision and the

use of a buccal graft did not influence postoperative outcome with respect

to EF. Sexual dysfunction is associated with urethral stricture and

validated questionnaires such as the International Index of Erectile

Function can assess erectile and ejaculatory function in men before and

after urethroplasty.127,133-137 A significant decline in the IIEF, is defined in

reported studies as a change of 5 points.137,138 . No correlation was found

with procedure type: onlay, flap, second-stage procedure in a study,

where no patients who underwent anastomotic urethroplasty experienced

a decline in erectile function.120 Similarly Nuss et al report overall sexual

dysfunction rate of 11%.117 Men with urethral stricture due to failed

hypospadias repair or lichen sclerosis were more likely to have sexual

dysfunction in this cohort. Of note in a study,120 16 patients experienced

significant improvement in erectile function after urethral reconstruction

(>5 points), 7 of whom were >45 years old. Authors believed this might

have resulted from the overall improvement in QOL after successful

urethroplasty correlating with increased psychological well-being.

Recently, 2 prospective studies have been published using the IIEF to

144
assess erectile function after urethroplasty. These studies of Erickson137

(52 patients) and Xie135 (125 patients) came to similar conclusions: about

40% reported diminished erectile function post-operatively with recovery

in most patients after 6 months.The overall ejaculatory function (EjF)

score has been shown to be significantly increased after surgery for all

ages (P < 0.001), except 50-59 and 60-69 years age group.129 Multivariate

analysis showed that neither the type of stricture repair nor the length of

stricture significantly altered overall EF, SD or EjF. As proposed by

Erickson et al the improvement in mean EjF score may be due to the

relief of the urethral obstruction, and resection of the acontractile, scarred

segment of the urethra/spongiosum which improves the rhythmic

expulsion mechanism by re-establishing the continuity of the

musculature. In a korean series, 2 patients complained of decreases in

ejaculatory force and volume.139 Barbagli et al140 reported that 23.3% of

patients had postoperative ejaculation disorder. The most frequent

postoperative ejaculation disorder was decreased force of ejaculation

(20%) or semen sequestration in the urethral bulb (3.3%).87 Yucel and

Baskin141 suggested that most likely surgical damage to the branches of

the perineal nerves or bulbospongiosus muscles may have a role in

determining the loss of efficient bulbar urethral contraction, thus causing

difficulties in expelling semen and urine.

145
ICI Q SF

While compairing preoperative ICI-Q-SF scores with postoperative

score,the difference in Score between the two intervals of both the

pairs(preop with 6 weeks and pre op with 6 months) was found to be

statistically significant (P˂0.05).The mean Score preoperatively was

16.46 which was significantly higher compared to 7.54 and 6.7 at 6

weeks and 6 months respctively. It implies that the mean score as per ICI-

Q-SF method differs significantly on compairing preoperative score with

6 weeks and 6 months postoperative score.

A prospective study done by Lumen N et al.150 (2011) in 21 patients who

underwent urethroplasty. The mean ICI-Q-SF score preoperative, 6 weeks

and 6 months postoperative was respectively 10.47, 8.33 (p = 0.04) and

9.47 (p = 0.31). Similar observations were made by Abrams P et al(2002)

and JTN Tamanini et al(2004).

USSPROM

The USS PROM incorporates LUTS and HRQoL domains, and a

treatment satisfaction question.

LUTS SCORE

While compairing preoperative status with post operative status at both

6 weeks and 6 months in all parameters namely LUTS, PEELING

146
VOIDING PICTURE & LUTS QOL the difference in Score between the

two intervals of both the pairs(preop with 6 weeks and pre op with 6

months) was found to be statistically significant (P˂0.05).

The mean preoperative score for LUTS, PELING PICTURE , LUTS QoL

were 16.6,3.1,2,7 respectively which was significantly higher than that in

post operative period the score were 15.3,2.78,1.86 at 6 weeks and

7.9,2.46,2.46 at 6 months .

While in case of EQVAS, the mean Score preoperatively was 39.74

which was significantly lower than 53.06 and 60.66 at 6 weeks and 6

months interval.

HRQoL DOMAINS

1. MOBILITY

Z- test was applied to determine the significant difference if any,

between the Difficulty Status of Mobility felt by patients before and after

6 weeks and 6 months of surgery.

It was evident that before surgery 10% of the patients had slight

difficulty in Mobility but after 6 weeks it decreased to 6% and after 6

147
months it decreased to 2%. However, in both the cases, the difference

was statistically non- significant (p> 0.05).

2. SELF CARE

Z- test was applied to determine the significant difference if any,

between the Difficulty Status of self care felt by patients before and after

6 weeks and 6 months of surgery.

It was evident that before surgery 10% of the patients had slight

difficulty in self care but after 6 weeks it decreased to 6% and after 6

months it decreased to 4%. However, in both the cases, the difference

was statistically non- significant (p> 0.05).

3. USUAL ACTIVITIES

Z- test was applied to determine the significant difference if any,

between the Difficulty status of usual activities felt by patients before and

after 6 weeks and 6 months of surgery.

It was evident that before surgery 8% of the patients had slight difficulty

in usual activities but after 6 weeks it decreased to 6% and after 6 months

it decreased to 4%. However, in both the cases, the difference was

statistically non- significant (p> 0.05).

148
4. PAIN/DISCOMFORT

Z- test was applied to determine the significant difference if any,

between the pain/discomfort felt by patients before and after 6 weeks and

6 months of surgery.

It was evident that before surgery 8% of the patients had severe pain but

after 6 weeks it decreased to 0% and after 6 months it remained 0%.

Similarly before surgery 92% patients had moderate pain but after 6

weeks it decreased to 10% and after 6 months it decreased to 4%. In all

the cases, the difference was statistically significant (p˂ 0.05).

5. DEPRESSION

Z- test was applied to determine the significant difference if any,

between the depression felt by patients before and after 6 weeks and 6

months of surgery.

It was evident that before surgery 94% of the patients had moderate

Depression but after 6 weeks it decreased to 6% and after 6 months it

further decreased to 0% . On the other hand, before surgery no patient

had slight depression but after 6 weeks 66% of patients developed slight

depression and 74% developed slight depression after 6 months.

Moreover, 24% new patients developed depression after 6 weeks of

149
surgery the percentage increased to 26% in 6 months . However none of

the patient had severe or moderate depression by 6 months of surgery.

3.OVERALL SATISFACTION

Z- test was applied to determine the significant difference if any,

between the overall level of satisfaction felt by patients before and after

6 weeks and 6 months of surgery.

It was evident that before surgery no patient was very satisfied but after 6

months the percentage increased to 10%. Moreover, 80% patients were

satisfed while 6% and 4% patients were unsatisfied and very unsatisfied

respectively after 6 months of surgery.

Study carried out by Jackson MJ et al.152 (2013) to evaluate urethral

reconstruction from the patients’ perspective using a validated patient-

reported outcome measure (PROM). 46 men with anterior urethral

stricture at four UK urology centres completed the PROM before

(baseline) and 2 yr after urethroplasty. Thirty-eight men underwent

urethroplasty for bulbar stricture and eight for penile stricture. The

median (range) follow-up was 25 (20–30) mo. Total LUTS scores (0 =

least symptomatic, 24 = most symptomatic) improved from a median of

12 at baseline to 4 at 2 yr (mean [95% confidence interval (CI)] of

differences 6.6 [4.2–9.1], p < 0.0001). A total of 33 men (72%) felt their

150
urinary symptoms interfered less with their overall quality of life, 8

(17%) reported no change, and 5 (11%) were worse 2 yr after

urethroplasty. Overall, 40 men (87%) remained ‘‘satisfied’’ or ‘‘very

satisfied’’ with the outcome of their operation. Health status visual

analogue scale scores (100 = best imaginable health, 0 = worst) 2 yr after

urethroplasty improved from a mean of 69 at baseline to 79 (mean [95%

CI] of differences 10 [2–18], p = 0.018). Health state index scores (1 =

full health, 0 = dead) improved from 0.79 at baseline to 0.89 at 2 yr

(mean [95% CI] of differences 0.10 [0.02–0.18), p = 0.012]). This is the

first study to prospectively evaluate urethral reconstruction using a

validated PROM. Men reported continued relief from symptoms with

related improvements in overall health status 2 yr after urethroplasty.

Bertrand LA et al.153 (2016) Men 18 years old or older with urethral

strictures undergoing urethroplasty were prospectively enrolled in a

longitudinal, multi-institutional urethroplasty outcomes database.

Preoperative and postoperative assessment included questionnaires to

assess lower urinary tract symptoms, pain, satisfaction and sexual

health.At a mean followup of 14 months we found a high 89.4% rate of

overall postoperative satisfaction in 433 patients and a high 82.8% rate in

those who would have chosen the operation again. Men with cystoscopic

recurrence were more likely to report dissatisfaction (OR 4.96, 95% CI

2.07–11.90) and men reporting dissatisfaction had significantly worse

151
uroflowmetry measures (each p <0.02). When controlling for recurrence,

multivariate analysis revealed that urethra and bladder pain (OR 1.71,

95% CI 1.05–2.77 and OR 2.74, 95% CI 1.12–6.69, respectively), a

postoperative decrease in sexual activity (OR 4.36, 95% CI 2.07–11.90)

and persistent lower urinary tract symptoms (eg straining to urinate OR

3.23, 1.74-6.01) were independent predictors of dissatisfaction. Lucas

ET et al.154 in (2017) observed

from 35 consecutive patients who underwent urethroplasty. The mean

USS-PROM score also improved from 13.21 preoperatively to 3.36 after

surgery (p <0.001) and 84.3% of patients were satisfied or very satisfied

with surgical results. Similarly Horiguchi A et al.155 in (2018) chose 93

Japanese-speaking male patients with anterior urethral stricture who

underwent urethroplasty completed it before (baseline) and 6 months

after urethroplasty. Qmax was negatively correlated with the LUTS-total

scores (r=−0.61). Cronbach’s alpha was 0.80 and the test–retest intraclass

correlation coefficient for the LUTS-total score was 0.82. 83 patients

(89.2%) achieved stricture-free, which was defined as no re-stricture on

cystoscopy and no need for additional treatment. The mean total LUTS-

score improved from 12.4 at baseline to 3.7 postoperatively (p < 0.0001).

The mean EQ-5D visual analogue scores and EQ-5D index improved

from 61.2 and 0.76, respectively, at baseline to 77.9 and 0.89

152
postoperatively (p < 0.0001, p < 0.0001). 55 patients (59.1%) were “very

satisfied” with the outcome of their urethroplasty and 33 (35.5%) were

“satisfied”.

153
CONCLUSION AND SUMMARY

154
CONCLUSION AND SUMMARY

Patients suffering from urethral stricture disease and undergoing

urethroplasty have long been evaluated from surgeons veiw point and

patient reported outcomes after surgery were lacking. Interventions

targeting urethral stricture disease aim to improve symptoms and reduce

recurrence. Recurrence rates , qmax and urethrography are the well

established clinician oriented measures. a validated tool designed to

measure patient reported outcome after urethroplasty surgery is a recent

concept. questionnares used to describe patients perception of satisfaction

are ipss, iief, iciqsf and uss prom.The study was conducted in department

of general surgery MYH Hospital indore. This study was conducted

prospectively form January 2018 to march 2019 during which 50 patients

underwent urethroplasty surgery.

The conclusions of our study are:-

 Using patients as their own control, we have observed in patient-

reported outcomes, significant improvement in urinary symptoms

and QOL scores with preservation or improvement of erectile

function after urethroplasty.

 After urethroplasty surgery the patient concerns with pain, sexual

function and voiding complaints are the primary determinants of

155
 patient satisfaction. Patients with objective evidence of recurrent

stricture were more likely to be satisfied if they reported minimal

pain, erectile and voiding dysfunction.

 At 6 weeks after urethroplasty, 0% of the patient had recurrence of

stricture; 1% of patients had incontinence, 0.5% of patients

developed urocutaneous fistula ,1.5% of patients developed wound

infection.

 At 6 months after urethroplasty, 1% of the patient had recurrence of

stricture; 1% of patients had incontinence, 0.5% of patients

developed urocutaneous fistula ,0.5% of patients developed wound

infection.

 Good results were seen in 10% of patients and Fair results were

seen in 86%of patients. While poor results were seen in 4% of

patients.

Fulfilling patient expectations from urethroplasty goes beyond technical

outcomes and should ultimately serve the patient with improved overall

quality of life. The last decade has witnessed a rapid evolution in

operative approaches to urethral reconstruction most of these incremental

improvements were never tested in context of control clinical trails, hence

A well designed PROM is necessary to stablish balance between what

patients consider as satisfaction and what experts considers as success.

156
only a widespread implementation of such PROMS can objectively

compare surgical outcomes and ultimately refine techniques towards

improved outcome of patients. It is important to stress on the point, that

subjective data and feedback about the LUTS (Lower Urinary Tract

Symptoms), erectile function and overall satisfaction are equally

important as objective data. They should be included in the regular follow

up of cases of urethroplasty

157
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 PROFORMA

IPD/OPD No. Date :

Name

Age at time of surgery

Address

Mobile No.

Religion

Socio-economic Status

Investigations

Type of surgery / Type of Suture use

Stricture site

Type of catheter use

No. of days Catheter insitu

Post OP Complications

Difficulty in micturition

Dribbling

Sleeplessness night

Pain

183
Perianal itching

Blockage

Incontinence

Haematuria

Wound Infection

Urocutaneous Fistula formation

QUESTIONNARES

IPSS SCORE

IIEF SCORE

ICI-Q-SF SCORE

USS-PROM

184