innovating to save lives

Penile Measurements in Rural Tanzanian Males: Informing Male Circumcision Device Design
by: Kristin Chrouser1,2; Eva Bazant1; Linda Jin1,3; Tigistu Adamu1,2; Baldwin Kileo1; Kelly Curran1,2; Hally Mahler1; Sifuni Koshuma4; Marya Plotkin1 and Harshad Sanghvi1,2 1 Jhpiego, 2Johns Hopkins Bloomberg School of Public Health, 3Washington University School of Medicine in St. Louis, 4Ministry of Health/Tanzania

Introduction: Why a VMMC Device?

n Male circumcision reduces female-to-male HIV
transmission by ~60%.

results
penile Measurements by reported Age Group
Measurement Variable Age 1013 (n=52) Median (IQR)
l1 Stretched penile length (cm) l2 Glans length (cm) C1 Girth/circumference of shaft proximal to corona (cm) C2 Girth/circumference at coronal ridge/margin (cm) 1A Foreskin stretched diameter at most distal end (cm) 1B Foreskin thickness under tension (mm) 1C Distance from the coronal ridge to the distal edge of the foreskin (cm)
7.5 (6.4, 8.3) 1.8 (1.5, 1.9)

Discussion
n Accurate penile measurements can guide device
Age 1949 (n=93) Median (IQR)
11.5 (10.7, 12.3) 2.9 (2.6, 3.2)

n WHO and UNAIDS recommend rapid scale-up of

voluntary medical male circumcision (VMMC) as part of a comprehensive HIV prevention package.

Age 1418 (n=107) Median (IQR)

10 (8.3,11.2) 2.5 (2.1, 2.8)

Mean (SD)
7.4 (1.5) 1.7 (0.4)

Mean (SD)
9.7 (2.0) 2.4 (0.5)

Mean (SD)
11.5 (1.6) 2.9 (0.4)

n Over 20 million VMMCs are needed to reach 80%

coverage and avert 3.4 million new HIV infections by 2025, according to mathematical modeling.

n Devices can potentially accelerate the pace of VMMC

scale-up by facilitating provision of circumcision by nonphysician clinicians.

development and match device sizes with the target population demanding VMMC services. Most adult VMMC devices were initially developed and tested in non-African men, using data from other populations. Comparing our data to parameters from prior studies is important, as use of inaccurate assumptions for device development and size predictions can lead to wasted time and resources, as well as poor surgical outcomes.

5.5 (5.0, 6.0)

5.6 (0.8)

7.9 (7.0, 8.5)

7.6 (1.3)

8.5 (8.1, 9.0)

8.7 (0.9)

n Adult (age 19+) stretched penile length in this study [11.5

+/- 1.6 cm] is near the lower end of the spectrum of other studies in the world literature, where length varies from 9.6 cm to 16.7 cm. These findings are not similar to prior published reports from sub-Saharan Africa, which were conducted in West Africa.

n Several devices have been designed and are in various

stages of testing, piloting and approval by national and international regulatory bodies and WHO.

5.5 (5.0, 5.8)

5.5 (0.9)

7.9 (6.9, 8.7)

7.6 (1.4)

8.8 (8.2, 9.4)

8.8 (0.9)

n To date, there is not definitive evidence showing that any

device fully satisfies WHOs ideal device definition.

2.6 (2.3, 3.0)

2.7 (0.6)

4.0 (3.3, 4.5)

3.9 (0.9)

4.6 (4.2, 4.9)

4.6 (0.7)

n There are several potential explanations for this finding:

n later puberty compared to higher income countries:

n WHOs ideal device definition:

n Safe n Acceptable to clients, partners, parents/caregivers

1.1 (1.0, 1.2)

1.2 (0.3)

1.3 (1.2, 2.0)

1.5 (0.5)

1.4 (1.2, 1.8)

1.5 (0.5)

and providers n Suitable for use by non-physician clinicians n Inexpensive

2.5 (2.0, 2.8)

2.5 (0.6)

3.0 (2.6, 3.4)

3.0 (0.6)

3.3 (3.0, 3.6)

3.3 (0.6)

IQr = interquartile range (25%ile to 75%ile) ; SD = Standard Deviation

Introduction: Why Do Measurements?

DATA-DrIVeN DeVICe DeVelOpMeNT Match supply and demand for appropriate device sizes: n Detailed penile/foreskin measurements from an African population are not available in the current literature, especially for adolescents and young adults, who compose a large percentage of VMMC clients. n prior studies evaluating correlations between somatometric measurements (height, weight, etc.) and penile dimensions have been inconclusive. If correlations are found in this population, they might simplify device size predictions. n Correct device size forecasting for the population of males seeking VMMC is essential for efficient supply chain management. COrreCT DeVICe fIT/fUNCTION Safe and effective VMMC: n Intraoperative safety and effective VMMC: Devices designed to accommodate a range of anatomic variations of the foreskin and glans and maintain appropriate functionality Devices appropriately sized to fit clients and avoid intraoperative penile injury n postoperative safety and acceptability: Too large and the device could prematurely detach prior to adequate healing Too small and the device could cause discomfort (affecting acceptability), excessive edema or pressure necrosis

Tanner Stage by reported Age Group

100% 90% 80% 70% 60% 50% 40% 30% 20% 10% 0% Age 1013 Age 1418 Age 1949 Stage 5 Stage 4 Stage 3 Stage 2 Stage 1
Almost a third of men 19+ years of age had not yet reached sexual maturity

Somatometric Measurements by Age Group

Measurement Variable Age 1013 (n=47) Median (IQR)
Height (cm) Weight (kg) Body Mass Index (kg/m2)
135 (123.0, 140.0) 30.0 (26.0, 32.0) 16.5 (15.3, 17.9)

Age 1418 (n=90) Median (IQR)

152.0 (146.0, 158.0) 44.0 (39.0, 50.0) 19.1 (17.3, 20.4)

Age 1949 (n=61) Median (IQR)

165 (161.0, 170.0) 59 (51.0, 61.0) 20.8 (19.8, 22.3)

Mean (SD)
133.3 (0.9) 29.5 (5.0) 16.5 (1.8)

Mean (SD)
151.5 (9.7) 44.1 (8.4) 19.1 (2.3)

Mean (SD)
164.6 (7.6) 57.7 (7.1) 21.3 (2.7)

Over 30% of clients in the adult category (age 19+) had not yet attained sexual maturity (according to Tanner staging) and therefore might not have yet achieved adult penile size. This is supported by a Nigerian series from 1985, which showed that only 47% of males had reached full maturity by age 19 and 89% by age 21. In contrast, a study from the Netherlands found that 90% of males reached maturity by age 18, while US data are similar, with 91% of males showing mature pubic hair patterns by age 18. n Stunted growth in this region of Tanzania: The 2010 Demographic and Health Survey in Tanzania noted high rates of under-nutrition, as 52% of children under 5 years of age in Iringa region were found to be stunted. Nutritional status can affect both somatometric parameters and pubertal timing. n Sample weighted toward young adults: The study used a quota sampling method to evaluate a typical VMMC population within several age categories to guide device design and sizing. The study was not designed to establish detailed, age-specific norms for penile parameters as such detail was unnecessary and would have required much larger sample sizes. As a result, 69% of clients in the adult age group were <25 years old. This preponderance of young adults magnifies any contribution (even if small) of stunting or delayed sexual maturity discussed above.

n=198. Not all patients had data on height and weight available.

n Whatever the underlying reasons for these differences,

they are operationally relevant.A large proportion of males seeking VMMC in Iringa are young adults or adolescents who have not yet achieved their full growth potential. The findings from this study contribute important information to inform the rollout of a devicebased VMMC program in this and other countries.

n The median BMI in adults in this study was 20, in boys

age 1013 years was 16.5, and in those age 1418 years was 19.1. In adults, normal BMI is defined as 18.5 to 24.9, underweight as <18.5, overweight as 25 to 29.9 and obese at >30. In boys who are still growing, BMI reference curves (BMI by age) are used instead of the categories above, making classification more challenging. In general, in this population of both boys and adult males, there was minimal obesity. pearson Correlations of penile and Somatometric Measurements
Both height and weight are correlated with most penile dimensions

Conclusions
n penile parameters measured in this study were more
detailed than any previous evaluation to date in a rural/ peri-urban African population.

n This descriptive study provides critical baseline penile

measurements to inform VMMC device development and allows accurate device size forecasting for supply chain management in VMMC delivery.

Measurement Variable
Stretched penile length (base to p of glans) (cm) Glans length (coronal ridge to p) (cm) Girth/circumference of sha just proximal to the corona with foreskin retracted (cm) Girth/circumference at coronal ridge/margin with foreskin retracted (cm) Foreskin stretched diameter at most distal end (cm) Foreskin thickness under tension (mm) Distance from coronal ridge to distal edge of the foreskin (cm)
a b

Height (cm)
0.69 0.68 0.78 0.80 0.68 0.27 0.49

Weight (kg)
0.73 0.71 0.78 0.81 0.71 0.30 0.49

Body Mass Index (kg/m2)

0.55 0.50 0.57 0.59 0.53 0.18* 0.32

n Somatometric correlations with penile dimensions may

be useful in providing a surrogate (non-genital) method to forecast device sizing/fit.

n This study should be repeated in additional settings

(urban locations, other countries, etc.) to establish generalizability of age-related measurements as well as more formal evaluation of age distribution of VMMC clients by region.

All results presented are signicant at p-value <.001 except where noted; * p<.05 Pearson correla ons are considered highly correlated when 0.9 to 1, high if 0.7 to 0.9, moderate if 0.5 to 0.7, low if 0.3 to 0.5, and li le if any correla on when 0 to 0.3.

Clients line up outside a VMMC clinic in Tanzania

Sca erplot of Glans Circumference at Coronal Margin (cm) and Client Height (cm)
12

Acknowledgments
n The authors recognize the support and collaboration of
Tanzanias Ministry of Health and Social Welfare. Thanks to the regional Authorities of Iringa region and the health facility staff at Tosamaganga Hospital, Makambako Hospital and Ilembula Hospital. Thanks also to Jhpiego Tanzania staff who assisted in this study.

Methods
n The study was approved by the National Institute for
Medical research in Tanzania and the IrB of the Johns Hopkins Bloomberg School of public Health.

n Clients aged 1049 undergoing VMMC in Tanzanias Iringa

region during July and September 2011 were invited to participate. participants were recruited from three health facilities: n Makambako Hospital (peri-urban) n Tosamaganga Hospital (rural) n Ilembula Hospital (rural)

n A quota sampling method was used to accrue clients in

each of three age categories.
120 140

Circumference at coronal margin (cm) 6 8 10

n Client consent was obtained for all study participants

age 18+. parental consent and client assent was obtained for all study participants under age 18.

Height (cm)

160

180

n After local anesthesia and before circumcision,

measurements of the glans, shaft and foreskin were collected using calipers, rulers and tape measures. Age, Tanner stage (metric for sexual maturity), height and weight were also recorded.

This graphical depiction of the correlation between glans circumference This graphical and client height suggests how height might be used to help predict depiction of the correlation device size/fit.

n Glans and foreskin measurements are most critical to

device fit. Glans circumference was highly correlated with client height (r=0.80, p<.001) and weight (r=0.81, p<.001). Stretched diameter of the distal foreskin was moderately correlated with patient height (r=0.68, p<.001) and weight (r=0.71, p<.001). review of the literature (focused on adults) demonstrates weak or no correlation between these metrics.

between glans circumference and client height suggests how height might be used to help predict device size/fit.

n penile measurements, Tanner stage, height, weight and

BMI were analyzed within age categories. Correlations between penile parameters and height, weight and BMI were also calculated.