Oral Mucosal Graft Versus Labial Graft in Female Urethroplasty

NCT ID: NCT07153861

Last Updated: 2025-09-04

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

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-02-26

Study Completion Date

2026-01-01

Brief Summary

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This study aims to compare the oral versus labial graft in female urethroplasty in female urethral stricture.

Detailed Description

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Female urethral stricture is an uncommon condition with an estimated prevalence of 4%-13% in women with bladder outlet obstruction.

Urethral reconstruction may become the treatment of choice in stricture recurrence following the failure of minimally invasive procedures. and the use of flaps and grafts has all been proposed. Different materials (e.g., vaginal and genital mucosal graft or flap, bladder mucosal flap, and oral mucosal graft) have been reported for augmentation urethroplasty.

Conditions

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Oral Mucosal Graft Labial Graft Female Urethroplasty

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Group 1

Patients will be admitted for the surgical management by the oral mucosal graft urethroplasty with the anterior onlay technique.

Group Type EXPERIMENTAL

Oral mucosal graft

Intervention Type PROCEDURE

Patients will be admitted for the surgical management by the oral mucosal graft urethroplasty with the anterior onlay technique.

Group 2

Patients will be admitted for the surgical management by the labial graft urethroplasty with the anterior onlay technique.

Group Type EXPERIMENTAL

Labial graft

Intervention Type PROCEDURE

Patients will be admitted for the surgical management by the labial graft urethroplasty with the anterior onlay technique.

Interventions

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Oral mucosal graft

Patients will be admitted for the surgical management by the oral mucosal graft urethroplasty with the anterior onlay technique.

Intervention Type PROCEDURE

Labial graft

Patients will be admitted for the surgical management by the labial graft urethroplasty with the anterior onlay technique.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Female patients with urethral stricture.
* Female patients with non-traumatic urethral stricture.

Exclusion Criteria

* Female patients with traumatic urethral stricture.
* Female patients with systemic contraindications of surgery like bleeding disorders.
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Tanta University

OTHER

Sponsor Role lead

Responsible Party

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Mohamed Ibrahim Ahmed Elmaadawy

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

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Tanta University

Tanta, El-Gharbia, Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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Elmaadawy I Elmaadawy, MD

Role: CONTACT

00201060245430

Facility Contacts

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Mohamed I Elmaadawy, MD

Role: primary

00201060245430

Other Identifiers

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36264PR1113/2/25

Identifier Type: -

Identifier Source: org_study_id

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