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NCT Number: NCT07074717

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

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.

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Key information

Age range

18 month and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Tanta University

Tanta, El-Gharbia Governorate, Egypt, 31527, Egypt

Location status: Recruiting

Location contact

Mohamed I Elmaadawy, MD

CONTACT

[email protected]

00201060245430

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Buccal Mucosal Graft (BMG) Urethroplasty

Procedure

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.

Other names: Dorsal onlay buccal mucosal graft

Penile Skin Graft (PSG) Urethroplasty

Procedure

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.

Other names: Dorsal onlay penile skin graft

Primary outcomes

  1. Surgical Success Rate

    Time frame: 9 months postoperatively

    Success is defined as satisfactory urinary stream with no need for further intervention (such as dilatation or DVIU) and no evidence of stricture on retrograde urethrogram during follow-up.

Secondary outcomes

  1. International Prostate Symptom Score (IPSS)

    Time frame: 9 months postoperatively

    Evaluation of changes in urinary symptoms using International Prostate Symptom Score (IPSS) to assess functional outcome and patient comfort after urethroplasty will be assessed.

  2. Length of Urethral Stricture

    Time frame: Intraoperatively

    Length of Urethral Stricture will be measured to compare the characteristics of strictures managed by each graft technique.

  3. Postoperative Complications

    Time frame: 9 months postoperatively

    Complications such as infection, bleeding, graft failure, and fistula formation following surgery will be recorded.

Study contacts

Contact information is provided by the study sponsor or research team.

Mohamed I Elmaadawy, MD

CONTACT

[email protected]

00201060245430

Sponsors and collaborators

Lead sponsor

Tanta University

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Jul 20, 2025
Registry last updated
Jul 20, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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