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

NCT ID: NCT07074717

Last Updated: 2025-07-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-01-01

Study Completion Date

2025-12-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Penile Skin Buccal Mucosal Graft Augmentation Urethroplasty Long Anterior Urethral Stricture

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Buccal Mucosal Graft (BMG)

Participants will undergo dorsal onlay augmentation urethroplasty using a buccal mucosal graft harvested from the inner cheek. The procedure is performed under spinal or general anesthesia. Graft is sutured dorsally over the strictured urethral segment after excision of the fibrotic tissue.

Group Type EXPERIMENTAL

Buccal Mucosal Graft (BMG) Urethroplasty

Intervention Type 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.

Penile Skin Graft (PSG)

Participants will undergo dorsal onlay augmentation urethroplasty using a penile skin graft harvested from the ventral surface of the penis. The hairless skin is prepared and sutured dorsally over the strictured urethral segment. The procedure is done under spinal or general anesthesia.

Group Type EXPERIMENTAL

Penile Skin Graft (PSG) Urethroplasty

Intervention Type 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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type 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.

Intervention Type PROCEDURE

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Dorsal onlay buccal mucosal graft Dorsal onlay penile skin graft

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Months

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Tanta University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Mohamed Ibrahim Ahmed Elmaadawy

Lecturer of Urology, Faculty of Medicine, Tanta University, Tanta, Egypt.

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Tanta University

Tanta, El-Gharbia Governorate, Egypt, Egypt

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Egypt

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Mohamed I Elmaadawy, MD

Role: CONTACT

00201060245430

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Mohamed I Elmaadawy, MD

Role: primary

00201060245430

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

36264PR1074/1/25

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.