Evaluation of the Method and Duration of Urinary Diversion in the Management of Distal Penile Hypospadias Following Surgical Repair.

February 12, 2026 updated by: Ain Shams University
This study aims to conduct a head-to-head comparison to determine the optimal method and duration of urinary diversion following distal penile hypospadias repair. Specifically, it will evaluate whether urethral diversion alone or a combination of urethral and suprapubic diversions provides better outcomes, and whether a postoperative duration of one week or two weeks is more effective.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

86

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 Locations

  • Egypt
      • Cairo, Egypt, 11517
        • Ain Shams University

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
  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Patients with Distal Hypospadias (Glanular, Coronal, Subcoronal)
  • Patients have Adequate ventral penile skin mobility

Exclusion Criteria:

  • Patients with Crippled hypospadias.
  • Patients with Proximal hypospadias.
  • Patients with Hypoplastic urethra.
  • Patients with Neurogenic bladder

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Patients who will be left with urethral catheter alone for 1 week.
Procedure: Application of urethral catheter alone for 1 week.
Application of urethral catheter alone for 1 week.
Active Comparator: Patient who will be left with urethral catheter for 2 weeks.
Procedure: Application of urethral catheter alone for 2 weeks.
Application of urethral catheter alone for 2 weeks.
Active Comparator: Patients who will be left with urethral stent and suprapubic catheter for 1 week
Procedure: Application of urethral stent and suprapubic catheter for 1 week
Application of urethral stent and suprapubic catheter for 1 week
Active Comparator: Patients who will be left with urethral stent and suprapubic catheter for 2 weeks
Procedure: Application of urethral stent and suprapubic catheter for 2 weeks
Application of urethral stent and suprapubic catheter for 2 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Decreased rate of fistula occurrence
Time Frame: 1 month
1 month

Collaborators and Investigators

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

Sponsor

Ain Shams University

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

  • 1. McDougal, W. S., Wein, A. J., Kavoussi, L. R., Partin, A. W., & Peters, C. A. (2015). Campbell-Walsh urology 11th Edition review e-book. Elsevier Health Sciences..

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)

April 10, 2025

Primary Completion (Actual)

October 15, 2025

Study Completion (Actual)

December 12, 2025

Study Registration Dates

First Submitted

February 12, 2026

First Submitted That Met QC Criteria

February 12, 2026

First Posted (Actual)

February 19, 2026

Study Record Updates

Last Update Posted (Actual)

February 19, 2026

Last Update Submitted That Met QC Criteria

February 12, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Hypospadias diversion

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

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.

Clinical Trials on Hypospadias

Clinical Trials on Application of urethral catheter alone for 1 week.

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Burundi

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe