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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Anterior Urethral Stricture, Male
• Intervention / Treatment: Procedure: Penile skin graft substituttion urethroplasty; Procedure: Buccal Mucosal Graft substitution urethroplasty

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 Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Mohamed Anwar, A. lecturer; Phone Number: 00201155678282; Email: m0anwar2005@gmail.com
• Study Contact Backup: Name: Ahmed Alrefaey, lecturer; Phone Number: 00201149394121; Email: urologydepartment@azhar.edu.eg

Study Locations

• Egypt
  • Cairo, Egypt, 11511
    • Recruiting
    • Al-Azhar urology department, Al-Azhar university hospitals
    • Contact: Malakah Mohamed, secretary; Phone Number: +20225107222; Email: urologydepartment@azhar.edu.eg
    • Contact: Samah Adel, secretary; Phone Number: 00201007561116

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: PSG group; The group of patients who will undergo penile skin graft substitituion of long anterior urethral stricture	Procedure: Penile skin graft substituttion urethroplasty; substitution of long anterior urethral strictures using one-sided dorsal perineal approach
Active Comparator: BMG group; The group of patients who will undergo buccal mucosal graft substitituion of long anterior urethral stricture	Procedure: Buccal Mucosal Graft substitution urethroplasty; substitution of long anterior urethral strictures using one-sided dorsal perineal approach

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: Al-Azhar University
• Investigators: Study Director: Ahmed Fahim, professor, Urology department, Al-Azhar university, Cairo, Egypt; Study Chair: Mostafa Ezzeldein, professor, Urology department, Al-Azhar university, Cairo, Egypt

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2022
• Primary Completion (Estimated): June 1, 2024
• Study Completion (Estimated): August 1, 2024

Study Registration Dates

• First Submitted: August 11, 2023
• First Submitted That Met QC Criteria: September 26, 2023
• First Posted (Actual): September 28, 2023

Study Record Updates

• Last Update Posted (Actual): September 28, 2023
• Last Update Submitted That Met QC Criteria: September 26, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Keywords: PSG; urethral stricture; urethroplasty; BMG; penile skin
• Additional Relevant MeSH Terms: Urologic Diseases; Pathological Conditions, Anatomical; Urethral Diseases; Urethral Obstruction; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Constriction, Pathologic; Urethral Stricture
• Other Study ID Numbers: 773

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Patients' data sheet, patient consent forms through my E-mail: m0anwar2005@gmail.com
• IPD Sharing Time Frame: The data will be available after 1 year, and for 2 years.
• IPD Sharing Access Criteria: My e-mail: m0anwar2005@gmail.com
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No