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

Al-Azhar University

Status: Enrolling

Conditions: Anterior Urethral Stricture, Male

Treatments: Procedure: Buccal Mucosal Graft substitution urethroplasty; Procedure: Penile skin graft substituttion urethroplasty

Study type: Interventional

Funder types: Other

Identifiers

NCT06056856

773

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 estimated patients

Sex: Male

Ages: 5+ years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

PSG group

Active Comparator group

Description:

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

Treatment:

Procedure: Penile skin graft substituttion urethroplasty

BMG group

Active Comparator group

Description:

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

Treatment:

Procedure: Buccal Mucosal Graft substitution urethroplasty