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

Sponsor

Al-Azhar University (Other)

Overall Status

Recruiting

CT.gov ID

NCT06056856

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

2.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Anterior Urethral Stricture, Male	Procedure: Penile skin graft substituttion urethroplasty Procedure: Buccal Mucosal Graft substitution urethroplasty	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

60 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

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

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Jun 1, 2022

Anticipated Primary Completion Date :

Jun 1, 2024

Anticipated Study Completion Date :

Aug 1, 2024

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

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

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

5 Years and Older

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Al-Azhar urology department, Al-Azhar university hospitals	Cairo		Egypt	11511

Sponsors and Collaborators

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