Indian J Gastroenterol (March–April 2017) 36(2):99–104
DOI 10.1007/s12664-017-0731-y
ORIGINAL ARTICLE
Effect of biofeedback therapy on anorectal physiological
parameters among patients with fecal evacuation disorder
Abhai Verma 1 & Asha Misra 1 & Uday C Ghoshal 1
Received: 25 September 2016 / Accepted: 20 January 2017 / Published online: 18 February 2017
# Indian Society of Gastroenterology 2017
Abstract
Background Though biofeedback therapy is often effective in
patients with fecal evacuation disorder (FED), a common
cause of chronic constipation (CC) in tertiary practice, data
on anorectal physiological parameters following it are scanty.
Methods Consecutive patients with FED with CC diagnosed
by abnormalities in at least two of the three tests (anorectal
manometry, defecography, and balloon expulsion test [BET])
undergoing biofeedback (two sessions per day, 30 min each,
for 2 weeks) during a 3-year period were analyzed. Clinical
evaluation, anorectal manometry (ARM), and BET were per-
formed at the beginning and after biofeedback.
Results Incomplete evacuation 42/43 (98%), straining 40/43
(93%), and feeling of outlet obstruction 35/43 (81%) were the
most common symptoms among these 43 patients (median
age 44 years, range 18–76, 30 [71%] male). All the three tests
(defecography, BET, and ARM) were abnormal in 17 (40%)
patients and the others had two abnormal tests. Improvement
in physiological parameters was noted following biofeedback
(median residual anal pressure during defecation 99 mmHg
(range 52–148) vs. 78 mmHg (37–182), p = 0.03; maximum
intra-rectal pressure 60 mmHg (90–110) vs. 76 mmHg (31–
178); p = 0.01; defecation index 1.1 (0.1–23.0) vs. 3.2 (0.5–
29.0); p = 0.001). Dyssynergia on ARM and BET got
corrected in 22/34 (65%) and 18/30 (60%) patients. At a 1-
month follow up, 23/37 (62%) patients reported satisfactory
symptomatic improvement.
Conclusions Biofeedback not only improves symptoms but
also anorectal physiological parameters in patients with FED.
* Uday C Ghoshal
udayghoshal@gmail.com
1
Department of Gastroenterology, Sanjay Gandhi Post Graduate
Institute of Medical Sciences, Lucknow 226 014, India
Keywords Anorectal physiology . Chronic constipation .
Defecography . Manometry . Treatment
Introduction
Chronic constipation may be broadly classified into
constipation-predominant irritable bowel syndrome (IBS-C)
and functional constipation, either of which may be associated
with slow colon transit and fecal evacuation disorder (FED)
[1, 2]. These disorders often overlap with each other in a
variable degree [2, 3]. Unlike slow transit constipation
(STC) and IBS-C, in which pharmacotherapy is the corner-
stone of management, FED is primarily managed by biofeed-
back [4]. FED is characterized by either deficient pelvic floor
support or abnormal contraction of pelvic muscles [3].
Surgery for structural defects such as rectocele and/or trained
coordinated exercise of pelvic muscles are the cornerstone of
treatment for FED depending upon the predominant patho-
physiology [5]. Biofeedback [6] involves real-time training
of coordinated contraction of pelvic muscles and relaxation
of anal sphincters to evacuate the rectum. In the process, pa-
tient is given live feedback about the status of the rectal emp-
tying and also about coordinated contraction of pelvic muscles
and relaxation of anal sphincters. Various studies have shown
varied results of biofeedback in patients suffering from FED
[7–21]. These studies have wide variations in inclusion and
diagnostic criteria of FED, severity of disease, and most im-
portantly the end point of intervention. The objective end
point of treatment is difficult to define in FED. Some studies
have evaluated complete spontaneous bowel movement
(CSBM) per week as the objective end point for biofeedback
for FED [2, 19, 20] whereas others have looked at the changes
in manometric parameters. In the present study, we have
100 Indian J Gastroenterol (March–April 2017) 36(2):99–104

evaluated the effect of biofeedback therapy on physiological reduction in anal pressure (≤20% baseline pressure), and type
parameters as assessed by manometry in patients with FED. IV is an inadequate increase in rectal pressure of (<40 mmHg)
accompanied by a failed reduction in anal pressure (≤20%
baseline pressure).
Methods
Biofeedback protocol Patients who fulfilled criteria for FED
Study protocol Prospectively maintained data of consecutive
and did not respond to standard treatment were treated with
patients undergoing biofeedback in the Gastrointestinal
biofeedback. Pressure-based visual biofeedback was per-
Pathophysiology and Motility Laboratory in a multi-level
formed by one of the authors (AM) using water perfused
teaching hospital in northern India during a 5-year period
high-resolution manometry system (G S Hebbard,
(June 2010 to June 2015) were retrospectively analyzed.
Australia). Each patient underwent two sessions of biofeed-
back per day (forenoon and afternoon) lasting for 30 min each,
Patients Those presenting with chronic constipation and di-
for 14 consecutive days. Normal physiology of defecation and
agnosed as FED based on standard criteria (Rome III) [22]
the abnormality in the index patient was explained in details
were included in the study. Patients undergoing major pelvic
before treatment. Biofeedback therapy was performed in the
surgery in the past, reporting active bleeding per rectum, anal
left lateral position. Subject was first asked to take a deep
fissure, or any major spinal deformity, were excluded. All the
diaphragmatic breath and then pushdown, as one would do
patients underwent a flexible sigmoidoscopy to rule out any
during defecation. Immediate feedback, verbal as well as vi-
organic pathology. Other contributing causes of constipation
sual as seen on the screen, was given to the subject.
like hypothyroidism, uncontrolled diabetes, and hypercalce-
Biofeedback therapy was performed with the manometry
mia were also investigated, and patients were excluded if these
catheter alone without a balloon, twice daily for about
disorders were not controlled. Information about bowel habit
30 min for 2 weeks. Patients were asked to expel the catheter.
including stool frequency per week, predominant consistency
During one 30-min session, the push down maneuver with
(Bristol scale), straining including its duration, feeling of in-
catheter in rectum was done for approximately 10–15 times.
complete evacuation, manual assistance during defecation,
No sensory training was given. Patients were given a stool
and use of enemas and suppositories was collected using a
diary and were asked to fill it before and after biofeedback.
standard questionnaire. Before and after completing all the
This diary comprised of important points about bowel habits
sessions of biofeedback, patients were asked about overall
like frequency, consistency (Bristol scale), straining, feeling of
satisfaction of their bowel habits.
incomplete evacuation, use of manual maneuvers, use of lax-
atives and enemas, and overall satisfaction. During biofeed-
Diagnosis of FED FED was diagnosed based on high-
back treatment, patients were allowed to take laxatives on
resolution anorectal manometry, BET, and barium
demand. Non-pharmacological measures like physical exer-
defecogram, which were performed using standard techniques
cise, increased water intake, and high fiber diet were also
described earlier [3]. Anorectal manometry (ARM) was per-
emphasized upon. Patients were also informed about the value
formed either by water perfusion (G S Hebbard, Australia) or
of the use of Indian type toilet and posture. ARM and BET
solid-state catheters (Sandhill Scientific, Milwaukee, WI,
were repeated at the end of the 15-day biofeedback protocol to
USA). An abnormal result in any of the three tests, such as
look for changes in various physiological parameters. Patients
anorectal manometry (anal basal sphincter pressure
undergoing ARM using water perfusion and solid-state cath-
>100 mmHg and/or squeeze pressure >167 mmHg, defecation
eter were subjected to ARM using the same system after bio-
index DI ≤1.4), defecography (lack of opening of the anorectal
feedback. Patients were also asked to report about overall
angle by >15° and/or perineal descend ≥4 or ≥2 cm rectocele),
satisfaction in their bowel symptoms at the completion of
and BET (≥200 g added weight needed to expel a balloon
treatment and at 1 month of follow up.
filled with 50 mL of water), was noted. However, FED was
diagnosed according to the Rome III criteria in the presence of
chronic constipation and abnormal result in at least two of the Statistical analysis Data were checked for normal distribu-
above-mentioned three tests [22]. Patients who showed tion using the Shapiro-Wilk test. Categorical and contin-
dyssynergic pattern of defecation were classified into four uous data were presented as proportion and mean, stan-
types. Type I is an adequate increase in rectal pressure dard deviation, median, and range depending upon their
(>40 mmHg) with paradoxical simultaneous rise in anal pres- distribution. Paired continuous data were analyzed using
sure, type II is an inadequate increase in rectal pressure paired t test or Wilcoxon signed-rank test depending on
(<40 mmHg) accompanied by a paradoxical simultaneous in- distribution. Categorical variables were analyzed using a
crease in anal pressure, type III is an adequate increase in chi-square test, with Yates’ correction as applicable.
rectal pressure (≥40 mmHg) accompanied by a failed P-values of <0.05 were considered significant.
Indian J Gastroenterol (March–April 2017) 36(2):99–104
Results
Patient profile The total number of patients identified during
the study period was 43 (median age 44 years, range 18 to
76 years) of which 30 (70%) were males. Median BMI for
males and females was 21.7 (17.3–36.0) and 19.9 (16.4–27.3),
respectively. Most of them complained about constipation for
long duration (median 56 months, range 8–120 months). All
patients were euthyroid at the time of biofeedback therapy and
their blood sugars were also within normal limits. No patient
reported complete relief of symptoms with laxatives. Median
stool frequency per week was 14 (range 2–70). The important
and characteristic symptoms of FED and their frequency are
shown in Table 1. Feeling of incomplete evacuation and
straining were the most common symptoms. All the patients
fulfilled Rome III criteria for IBS. Eleven (25%) patients re-
ported bleeding per rectum at least once in the last 6 months.
On investigation, these patients were found to have either
hemorrhoids or solitary rectal ulcer syndrome (SRUS).
Although all the patients complained about constipation but
when enquired about consistency of stool using Bristol stool
chart, only nine (21%) had type 1–3 stools. Diagnosis of FED
was made based on the abnormal test results on BET plus
ARM in 8 (18%), defecography plus BET in 12 (28%),
defecography and ARM in 6 (14%), and on all the three tests
in 17 (40%). All the patients completed the above-mentioned
biofeedback protocol. ARM and BET was repeated at the end
of therapy for all the patients.
Anorectal manometry and BET The pre- and post-
biofeedback manometric parameters are depicted in Table 2.
There was significant reduction in basal sphincter pressure
and anal pressure during defecation. Also, the maximal
intra-rectal pressure during defecation increased significantly
after biofeedback (Fig. 1). There was no difference in the
sensory parameters following biofeedback. Defecation index
(DI), defined as ratio of maximum intra-rectal pressure during
defecation to residual anal pressure, was calculated and values
≤1.4 were considered as abnormal [23, 24]. It is an important
parameter as values of >1.4 are needed for normal defecation.
Therefore, improvement in DI translates into better relief of
Table 1 Clinical
spectrum of patients with Symptom Number (%)
fecal evacuation disorder
Stool consistency
Bristol 1–3 9 (21%)
Bristol 4 8 (19%)
Bristol 5–7 26 (60%)
Straining 40 (93%)
Incomplete evacuation 42 (98%)
Outlet obstruction 35 (81%)
Manual assistance 16 (37%)
101
symptoms. Median pre-biofeedback DI was 1.1 (range 0.1 to
23.0), which improved to 3.3 (range 0.5 to 29; p-value = 0.001)
after biofeedback (Fig. 2). BET normalized from 7/43 (16.2%)
to 18/37 (48.6%) of patients after biofeedback (p = 0.004). We
classified all the patients into various types of dyssynergia and
found that type I dyssynergia was commonest (Fig. 3). Due to
small numbers of patients classified into other types of
dyssynergia, they were grouped into a single group (non-type
I). Overall dyssynergia was reversed in 32/43 (74%) patients
(20/26 in type I and 14/17 in non-type I; p = 0.6).
Follow up On follow up (available in 37, 83% patients),
straining (40/43 vs. 10/37, p=0.001), incomplete evacuation
(42/43 vs. 18/37, p=0.002), outlet obstruction (35/43 vs. 4/37,
p=0.001), and manual assistance for defecation (16/43 vs.
3/37, p=0.002) improved at 1-month. Overall satisfaction
regarding bowel symptoms at 1 month was found to be
23/37 (62%).
Discussion
The present study shows the beneficial effects of biofeedback
on objective physiological parameters in patients with FED.
Most of the important parameters, which were abnormal in
FED, like dyssynergic pattern, basal and residual sphincter
pressures, and intra-rectal pressure during defecation and ab-
normal balloon expulsion test improved with biofeedback.
There is paucity of data about FED and biofeedback therapy
for this group of disorder from India. Our study is the first one
from the country showing efficacy of biofeedback therapy on
physiological parameters in patients with FED.
In a recent study from India, Shah et al. [2] reported that
40% of all the subjects with primary constipation were having
dyssynergic defecation (DD) on ARM. The clinical efficacy
of biofeedback in this study was 70% as judged by complete
spontaneous bowel movement (CSBM). However, only 20
patients completed more than four sessions of biofeedback.
Moreover, ARM was not repeated at the end of biofeedback;
so changes in objective physiological parameters could not be
ascertained. In the present study, we have used a more strin-
gent biofeedback protocol and also demonstrated improve-
ment in physiological parameters at the end of this protocol.
Rao et al. [20] compared the biofeedback therapy with the
sham feedback in patients with DD. This is the only random-
ized controlled trial available in the literature comparing bio-
feedback with sham feedback therapy and standard therapy.
Although in this study the number of CSBMs per week did
improve significantly with biofeedback, global bowel satisfac-
tion score showed no significant improvement when com-
pared to standard therapy. They also showed improvement
in all the motor and sensory physiological parameters as
assessed by anorectal manometry. In the present study, we
102 Indian J Gastroenterol (March–April 2017) 36(2):99–104

Table 2 Effect of biofeedback on

anorectal parameters Parameter Pre-biofeedback Post-biofeedback p-value

Basal sphincter pressure (mmHg) 77 (52–128) 71 (42–105) 0.01

Squeeze pressure (mmHg) 167 (75–248) 141 (81–246) 0.22
Anal pressure during defecation (mmHg) 99 (52–148) 78 (37–182) 0.03
Intra-rectal pressure during defecation (mmHg) 60 (9–110) 76 (31–178) 0.01
Balloon distension—first sensation (cc) 40 (20–80) 40 (20–250) 0.66
Balloon distension—urge to defecate (cc) 100 (40–200) 100 (60–250) 0.73
Balloon distension—pain (cc) 250 (80–400) 250 (80–400) 0.39

have not included any sham therapy but improvement in pres-
sure parameters is almost similar.
In a study by Chiaroni et al. [9], biofeedback was compared
to laxatives in patients with FED. The primary outcome var-
iable in this study was patient’s perception of symptom im-
provement graded from zero to four. They used five sessions
of biofeedback in a week with each session lasting for 30 min,
using EMG instrument. At 6 and 12 months, 80% patients
reported major improvement in symptoms with biofeedback
as compared to 22% with laxatives. Almost similar results
have been shown in the present study (62% reporting overall
improvement at 1 month). However, the long-term follow up
is not available in the present study.
The phenotype of constipation appears to be one of the
major determinants of success of biofeedback. In a study,
comparing efficacy of biofeedback in patients with DD
and STC [8], 71% and 8% patients reported improvement
in their bowel habits, respectively. Also, 50% patients,
who had features of both types of constipation, reported
symptomatic improvement with biofeedback. Moreover,
patients in the DD experienced greater improvements in
stool frequency, laxative use, straining, and bloating than
patients in the STC group. Although there are few studies
which show that biofeedback is also effective in STC,
they have been criticized for their lack of strict differen-
tiation between DD and STC [10, 12, 25]. Because in
real-life situations, most patients show some overlap of
both the phenotypes; whatever improvement might have
occurred in the STC group may be actually due to under-
lying dyssynergia. Presence of IBS along with DD does
not affect the overall response [19]. However, if the CTT
is delayed in presence of IBS and DD, then response to
biofeedback is poor [19]. In the present study, CTT was
not evaluated.
There is wide variation in studies on biofeedback for
constipation in the type of intervention, duration of ther-
apy, and outcome measures. Among them, the most im-
portant factor, which needs discussion, is the outcome
measure to determine success. Most have used one of
the three factors as primary outcome: (i) anorectal

Fig. 1 High-resolution anorectal manometry plots of patients with fecal
evacuation disorder before and after biofeedback treatment with three-
dimensional reconstruction (indicated by B3-D^) of ano-rectum. The
dotted black lines on the plots indicate the time points where 3-D
reconstruction was made. Following biofeedback, during attempted
defecation, though intra-rectal pressure increased but anal sphincter
pressure reduced (reversal of dyssynergic pattern). a, b Before
biofeedback. c, d After biofeedback. RP resting pressure, SqP squeeze
pressure, AD attempted defecation
Indian J Gastroenterol (March–April 2017) 36(2):99–104
Fig. 2 Defecation index before and after biofeedback treatment among
patients with fecal evacuation disorders
physiological parameters, (ii) CSBM as assessed by stool
diaries, and (iii) global satisfaction in bowel symptoms.
Many studies have used multiple outcome measures with-
out stating clearly which was the primary outcome mea-
sure. A meta-analysis [26] failed due to the differences
between study populations, the heterogeneity of the dif-
ferent samples, and the large range of different outcome
measures. In the present study, we compared anorectal
parameters to ascertain success of biofeedback because it
is more objective and quantifiable. This objective param-
eter is supplemented by the subjective global satisfaction
about the bowel symptoms.
The present study is the first one from India reporting effect
of biofeedback on anorectal physiological parameters.
However, it has got a few limitations. First, there is lack of
data on long-term follow up. Second, there is no objective
clinical end point in our study.
Fig. 3 Pie chart showing number of patients in various categories of
dyssynergia
103
In conclusion, the present study demonstrates that biofeed-
back is effective in patients with DD. It not only improves the
overall satisfaction about bowel symptoms but also reverses
the dyssynergic pattern of defecation. More prospective stud-
ies with long-term follow up are needed on this issue.
Acknowledgement The authors thank Mr. Raghunath of the
Gastrointestinal Pathophysiology and Motility Laboratory at SGPGI,
Lucknow, for his technical support.
Compliance with ethical standards
Conflict of interest AV, AM, and UCG declare that they have no con-
flict of interest.
Ethics statement The authors declare that the study was performed in a
manner to conform with the Helsinki Declaration of 1975, as revised in
2000 and 2008, concerning Human and Animal Rights.
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