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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Anterior Urethral Stricture, Male

Intervention / Treatment
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* Procedure: Penile skin graft substituttion urethroplasty
* Procedure: Buccal Mucosal Graft substitution urethroplasty


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 5 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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urethral stricture, urethroplasty, BMG, PSG, penile skin