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

NCT07421271 | Completed DMC

• 1 other identifier: Hypospadias diversion
• Study Type: interventional
• Target: 86
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Hypospadias; Urinary Diversion

Outcome Measures

Primary Outcomes (1)

• Decreased rate of fistula occurrence

  1 month

Study Arms (4)

Patients who will be left with urethral catheter alone for 1 week.

ACTIVE COMPARATOR

Procedure: Application of urethral catheter alone for 1 week.

Patient who will be left with urethral catheter for 2 weeks.

ACTIVE COMPARATOR

Procedure: Application of urethral catheter alone for 2 weeks.

Patients who will be left with urethral stent and suprapubic catheter for 1 week

ACTIVE COMPARATOR

Procedure: Application of urethral stent and suprapubic catheter for 1 week

Patients who will be left with urethral stent and suprapubic catheter for 2 weeks

ACTIVE COMPARATOR

Procedure: Application of urethral stent and suprapubic catheter for 2 weeks

Interventions

Application of urethral catheter alone for 1 week. PROCEDURE

Application of urethral catheter alone for 1 week.

Patients who will be left with urethral catheter alone for 1 week.

Application of urethral catheter alone for 2 weeks. PROCEDURE

Application of urethral catheter alone for 2 weeks.

Patient who will be left with urethral catheter for 2 weeks.

Application of urethral stent and suprapubic catheter for 1 week PROCEDURE

Application of urethral stent and suprapubic catheter for 1 week

Patients who will be left with urethral stent and suprapubic catheter for 1 week

Application of urethral stent and suprapubic catheter for 2 weeks PROCEDURE

Application of urethral stent and suprapubic catheter for 2 weeks

Patients who will be left with urethral stent and suprapubic catheter for 2 weeks

Eligibility Criteria

• Age: 6 Months - 18 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Ain shams university

Cairo, 11517, Egypt

Location

Related Publications (1)

• 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..

  RESULT

MeSH Terms

Conditions

Hypospadias

Condition Hierarchy (Ancestors)

Urogenital Abnormalities; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Penile Diseases; Genital Diseases, Male; Genital Diseases; Male Urogenital Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 12, 2026
• First Posted: February 19, 2026
• Study Start: April 10, 2025
• Primary Completion: October 15, 2025
• Study Completion: December 12, 2025
• Last Updated: February 19, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share

Locations

EG (1)