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Clinical Trials/NCT07153861
NCT07153861RecruitingNot Applicable

Oral Mucosal Graft Versus Labial Graft in Female Urethroplasty: A Prospective Comparative Study

Tanta University1 site in 1 country40 target enrollmentStarted: February 26, 2025Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Recruiting
Enrollment
40
Locations
1
Primary Endpoint
Urine flow rate

Study Overview

Brief Summary

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

Detailed Description

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
Female
Accepts Healthy Volunteers
No

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.

Arms & Interventions

Group 1

Experimental

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

Intervention: Oral mucosal graft (Procedure)

Group 2

Experimental

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

Intervention: Labial graft (Procedure)

Outcomes

Primary Outcomes

Urine flow rate

Time Frame: 6 months post-procedure

Urine flow rate will be recorded.

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Mohamed Ibrahim Ahmed Elmaadawy

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

Tanta University

Study Sites (1)

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