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Recruiting NCT07074717

Penile Skin Versus Buccal Mucosal Graft in Augmentation Urethroplasty for Long Anterior Urethral Stricture

No phase Interventional Penile Skin Buccal Mucosal Graft Augmentation Urethroplasty

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Buccal Mucosal Graft (BMG) Urethroplasty, Penile Skin Graft (PSG) Urethroplasty.
Who it may be relevant to
Registry conditions: Penile Skin, Buccal Mucosal Graft, Augmentation, Urethroplasty. Basic parameters: from 18 months · Male.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Egypt
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Penile Skin Versus Buccal Mucosal Graft in Augmentation Urethroplasty for Long Anterior Urethral Stricture: A Prospective Randomized Study

Overview

The aim of this study is to analyze the outcomes of dorsal onlay buccal mucosal graft (BMG) and penile skin graft (PSG) urethroplasty in the management of long segment bulbar urethral stricture.

Detailed description

Penile urethral reconstruction proves to be a continuous challenge as no perfect technique is considered for all patients with this problem. Among all the methods used for treatment of urethral stricture, the substitution urethroplasty with tissue transfer using either flap or graft is the gold standard treatment option for long segment urethral strictures.

In 1993, McAninch described a circular fasciocutaneous flap for the management of penile urethral stricture up to 15 cm that showed excellent cosmetic and functional outcomes due to this being a hairless, flexible flap with a rich vascular supply.

Buccal mucosal graft (BMG) was rediscovered and popularized in 1992 by Burger et al., then El-Kassaby et al. in 1993 published a series using buccal mucosal graft to repair anterior urethral stricture. Buccal mucosal graft became an ideal urethral substitute due to easy harvesting, hairlessness and compatibility in a wet environment.

Interventions

  • Procedure Buccal Mucosal Graft (BMG) Urethroplasty
    Urethroplasty using a buccal mucosal graft harvested from the inner cheek. The graft is dorsally onlaid to reconstruct the strictured urethral segment. The procedure is conducted under spinal or general anesthesia.
  • Procedure Penile Skin Graft (PSG) Urethroplasty
    Urethroplasty using a penile skin graft harvested from the ventral surface of the penis. The graft is applied dorsally after excision of the fibrotic urethral segment. The surgery is performed under spinal or general anesthesia.

Primary outcome measures

  • Surgical Success Rate [Time frame: 9 months postoperatively]
Secondary outcome measures (3)
  • International Prostate Symptom Score (IPSS) [Time frame: 9 months postoperatively]
  • Length of Urethral Stricture [Time frame: Intraoperatively]
  • Postoperative Complications [Time frame: 9 months postoperatively]

Eligibility criteria

Inclusion criteria

  • Patients with long segment anterior urethral stricture that was defined as a stricture with a length of more than 1 cm with spongiofibrosis.
  • Patients with previous failed urethral dilatation or direct vision internal urethrotomy (DVIU)

Exclusion criteria

  • Patients with lichen sclerosus
  • Patients with history of hypospadias repair
  • Patients with recurrent urethral stricture after failed previous urethroplasty

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

Egypt · 1 center
  • Tanta University — Tanta

Identifiers

NCT: NCT07074717 · 36264PR1074/1/25

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗