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

Anterior Urethral Stricture, Male Clinical Trial

Official title:

Anatomical and Functional Outcome of Penile Skin Graft Versus Buccal Mucosal Graft for Urethral Substitution in Long Segment Anterior Urethral Strictures

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06056856
• Other study ID #: 773
• Status: Recruiting
• Phase: N/A
• Start date: June 1, 2022
• Est. completion date: August 1, 2024

Study information

• Verified date: September 2023
• Source: Al-Azhar University
• Contact: Mohamed Anwar, A. lecturer
• Phone: 00201155678282
• Email: m0anwar2005[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: August 1, 2024
• Est. primary completion date: June 1, 2024
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 5 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Anterior Urethral Stricture, Male
• Constriction, Pathologic
• Urethral Stricture

Intervention

Procedure:
• Penile skin graft substituttion urethroplasty
substitution of long anterior urethral strictures using one-sided dorsal perineal approach
• Buccal Mucosal Graft substitution urethroplasty
substitution of long anterior urethral strictures using one-sided dorsal perineal approach

Locations

Country	Name	City	State
Egypt	Al-Azhar urology department, Al-Azhar university hospitals	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Al-Azhar University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The degree of urethral lumen patency.	Patent urethra as evidenced by uroflowmetry and retrograde urethrography +/- urethroscopy	through study completion, an average of 1 year.
Secondary	Lower urinary tract symptoms improvement	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.	6 months
Secondary	Erectile function assessment	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.	6 months