Anatomical and Functional Outcome of Penile Skin Graft Versus Buccal Mucosal Graft for Urethral Substitution in Long Segment Anterior Urethral Strictures
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Al-Azhar University
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- The degree of urethral lumen patency.
Study Overview
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.
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 5 Years to — (Child, Adult, Older Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
BMG group
The group of patients who will undergo buccal mucosal graft substitituion of long anterior urethral stricture
Intervention: Buccal Mucosal Graft substitution urethroplasty (Procedure)
PSG group
The group of patients who will undergo penile skin graft substitituion of long anterior urethral stricture
Intervention: Penile skin graft substituttion urethroplasty (Procedure)
Outcomes
Primary Outcomes
The degree of urethral lumen patency.
Time Frame: through study completion, an average of 1 year.
Patent urethra as evidenced by uroflowmetry and retrograde urethrography +/- urethroscopy
Secondary Outcomes
- Lower urinary tract symptoms improvement(6 months)
- Erectile function assessment(6 months)
Investigators
Mohamed Ahmed Anwar
Assistant lecturer
Al-Azhar University