Gain in Stretched Penile Length After Phalloplasty With & Without Penile Traction in Children.

February 14, 2024 updated by: ADEEL AHMED, Shaikh Zayed Hospital, Lahore

The goal of this Randomized Controlled Trial is to assess the gain in stretched penile length after phalloplasty with & without penile traction in children of age group 4 to 13 years presenting in hospital with the complaint of concealed penis.

The main question[s] it aims to answer is:

• Gain in stretched penile length after phalloplasty with and without penile traction in children.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Concealed penis is a rare clinical entity that affects young males. It leads to various concerns about cosmesis even though it does not necessarily affect functional aspects such as micturition and intercourse. However, data suggests that up to 4% of individuals may be affected by a concealed penis and this can lead to great distress to the patient especially as the child ages. There are different methods of phalloplasty that are performed, however none have explored the possible benefit of traction to the penis after phalloplasty to increase stretched penile length. We conducted a pilot study where we found a modest increase in stretched penile length following traction with phalloplasty and believe that addition of this step will help individuals with a concealed penis following phalloplasty gain a modest increase in length. The hypothesis of this study is that there will be a significant mean gain in stretched penile length with traction for 24 hours following phalloplasty for concealed penis. The research conducted will be a Randomized Control Trial with two groups where one group receives traction while one group does not.

The net gain in stretched penile length, stretched penile length pre-operatively and 2 weeks post-operatively will be analyzed using the independent study T-test with a P-value of 0.05 or less as significant between the two groups. The difference between the baseline SPL and post-operative SPL for each group will be assessed using the paired student t-test with a p-value less than 0.05 as significant. Sample Size for our study will be 70 patients (35 in each group).

Phalloplasty is a well-known procedure in children presenting with concealed penis as ordinary circumcision may lead to phimosis and adhesions formation between glans and skin in concealed penis. This procedure is not associated with any untoward results (except Suture Cut-through the glans skin which can be easily repaired) as only traction will be applied & SPL will be measured immediately per-op & two weeks post operatively.

Since there is currently no local study assessing the increase in stretched penile length following phalloplasty with traction, we have done a pilot study (Annexure B) whose results were satisfactory with penile traction as compared to without penile traction therefore, we anticipate a notable augmentation in stretched penile length both prior to and post the procedure in each patient. This observation implies that employing 24-hour penile traction may be a recommended course of action, potentially opening the door for more comprehensive investigations to furnish additional evidence regarding the procedure's advantages. It is important to acknowledge that this study will face limitations due to the restricted sample size, primarily attributable to the rare nature of the condition. Given the limited existing literature on the subject, the substantial prevalence of the condition, and the absence of a consensus regarding the optimal approach for concealed penis, this study could contribute to the existing body of knowledge by examining the efficacy of combining penile traction with phalloplasty.

Study Type

Interventional

Enrollment (Estimated)

70

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: MUHAMMAD ALI SHEIKH, MBBS FCPS
  • Phone Number: 00923214790094
  • Email: drali444@yahoo.com

Study Locations

  • Pakistan
    • Punjab
      • Lahore, Punjab, Pakistan
        • Recruiting
        • Sheikh Zayed Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Infants and children aged 4 years to 13 years of age.
  • Presenting with concealed penis for circumcision.

Exclusion Criteria:

  • Congenital Buried Penis
  • Webbed penis
  • Structural abnormalities of the penis such as hypospadias, Epispadias etc.
  • Existing co-morbid syndromes or conditions
  • Unfit for general anesthesia
  • Known bleeding diathesis
  • Incomplete foreskin
  • Any previous penile surgery

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: With Traction Dressing
Traction dressing will be applied to patients after phalloplasty for 24 hours.
Procedure: Traction Dressing
Traction dressing will be applied to one group for 24 hours and simple dressing to the other group.
Other: Without Traction Dressing
No traction dressing will be applied to patients after phalloplasty for 24 hours.
Other: Without Traction Dressing
Without Traction Dressing

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The gain in stretched penile length (SPL)
Time Frame: up to 2 Years
To measure the gain in stretched penile length (SPL) following phalloplasty with and without penile traction applied for 24 hours for patients undergoing surgery for concealed penis at two weeks post-operatively.
up to 2 Years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shaikh Zayed Hospital, Lahore

Investigators

  • Study Chair: MUHAMMAD ALI SHEIKH, MBBS FCPS, Sheikh Zayed Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2023

Primary Completion (Estimated)

January 1, 2025

Study Completion (Estimated)

January 1, 2025

Study Registration Dates

First Submitted

December 11, 2023

First Submitted That Met QC Criteria

February 14, 2024

First Posted (Actual)

February 15, 2024

Study Record Updates

Last Update Posted (Actual)

February 15, 2024

Last Update Submitted That Met QC Criteria

February 14, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

  • ShaikhZayedH

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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