Anatomical and Functional Outcome of PSG Vs BMG for Urethral Substitution in Long Segment Anterior Urethral Strictures

Not Applicable

Recruiting

• Conditions: Anterior Urethral Stricture, Male

• Registration Number: NCT06056856
• Lead Sponsor: Al-Azhar University

Brief Summary

This study aims to compare the penile skin graft and buccal mucosal graft for substitution of long anterior urethral strictures using one-sided dorsal perineal approach.

Detailed Description

Since previous studies were:

* Retrospective and very few were prospective randomized studies

* Some studies were done on lichen sclerosis cases that have an adverse effect on the PSG outcome.

* The follow-up duration was longer for PSG patients.

* Stricture length was usually longer for PSG cases.

This study aims to compare the PSG and BMG for substitution of long anterior urethral strictures using one-sided dorsal perineal approach.

The investigators hypothesize that:

❶ Conducting a well-designed prospective, randomized study can help identify which technique is better than the other.

❷ Using the one-side dorsal approach can improve the outcomes of both techniques and identify their advantages and disadvantages.

Study Timeline

• Study Start: 2022-06-01
• Study First Submitted: 2023-08-11
• Status Verified: 2023-09
• Study First Submitted QC: 2023-09-26
• Last Update Submitted: 2023-09-26
• Study First Posted: 2023-09-28
• Last Update Posted: 2023-09-28
• Primary Completion: 2024-06-01
• Study Completion: 2024-08-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Male
• Target Recruitment: 60

Inclusion Criteria

• The study will include patients with long segment anterior urethral stricture (>2 cm).

Exclusion Criteria

• Urethro-cutaneous fistula, urethral abscess or diverticulum.
• A scarred and unsalvageable urethral plate or scarred perineum.
• Lichen sclerosis (Balanitis xerotica obliterans).
• Unhealthy/unavailable buccal mucosa.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
The degree of urethral lumen patency.	through study completion, an average of 1 year.	Patent urethra as evidenced by uroflowmetry and retrograde urethrography +/- urethroscopy

Secondary Outcome Measures

Name	Time	Method
Lower urinary tract symptoms improvement	6 months	lower urinary tract symptoms as assessed by the international prostate symptom score, ranging from 0 to 35, where scores from 0-7 are mild, from 8-19 are moderate, from 20-35 are severe symptoms.
Erectile function assessment	6 months	sexual function as assessed by the international index of erectile function-5 questionnaire, ranging from 5-25, where 22-25 is normal, 17-21 is mild ED, 12-16 is mild to moderate ED, 8-11 is moderate ED, and 5-7 is severe ED.

Trial Locations

Locations (1)

Al-Azhar urology department, Al-Azhar university hospitals; 🇪🇬 Cairo, Egypt