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
• Interventions: Procedure: Buccal Mucosal Graft substitution urethroplasty; Procedure: Penile skin graft substituttion urethroplasty

• 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

Arm && Interventions

Group	Intervention	Description
BMG group	Buccal Mucosal Graft substitution urethroplasty	The group of patients who will undergo buccal mucosal graft substitituion of long anterior urethral stricture
PSG group	Penile skin graft substituttion urethroplasty	The group of patients who will undergo penile skin graft substitituion of long anterior urethral stricture

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