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

NCT06056856 | Unknown DMC

• 1 other identifier: 773
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Anterior Urethral Stricture, Male

Keywords

urethral stricture; urethroplasty; BMG; PSG; penile skin

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Lower urinary tract symptoms improvement

  6 months

• Erectile function assessment

  6 months

Study Arms (2)

PSG group

ACTIVE COMPARATOR

The group of patients who will undergo penile skin graft substitituion of long anterior urethral stricture

Procedure: Penile skin graft substituttion urethroplasty

BMG group

ACTIVE COMPARATOR

The group of patients who will undergo buccal mucosal graft substitituion of long anterior urethral stricture

Procedure: Buccal Mucosal Graft substitution urethroplasty

Interventions

Penile skin graft substituttion urethroplasty PROCEDURE

substitution of long anterior urethral strictures using one-sided dorsal perineal approach

PSG group

Buccal Mucosal Graft substitution urethroplasty PROCEDURE

substitution of long anterior urethral strictures using one-sided dorsal perineal approach

BMG group

Eligibility Criteria

• Age: 5 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Al-Azhar University: lead

Study Sites (1)

Al-Azhar urology department, Al-Azhar university hospitals

Cairo, 11511, Egypt

RECRUITING

MeSH Terms

Conditions

Urethral Stricture

Condition Hierarchy (Ancestors)

Urethral Obstruction; Urethral Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• Ahmed Fahim, professor

  Urology department, Al-Azhar university, Cairo, Egypt

  STUDY DIRECTOR

• Mostafa Ezzeldein, professor

  Urology department, Al-Azhar university, Cairo, Egypt

  STUDY CHAIR

Central Study Contacts

Mohamed Anwar, A. lecturer

CONTACT

00201155678282; m0anwar2005@gmail.com

Ahmed Alrefaey, lecturer

CONTACT

00201149394121; urologydepartment@azhar.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant lecturer

Model Details: Two-arm parallel assignment. The first arm will be operated using penile skin grafts, The second arm will be operated using buccal mucosal grafts.

Study Record Dates

• First Submitted: August 11, 2023
• First Posted: September 28, 2023
• Study Start: June 1, 2022
• Primary Completion: June 1, 2024
• Study Completion: August 1, 2024
• Last Updated: September 28, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: The data will be available after 1 year, and for 2 years.
• Access Criteria: My e-mail: m0anwar2005@gmail.com

Locations

EG (1)