NCT07153861

Brief Summary

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

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 26, 2025

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

August 24, 2025

Completed
11 days until next milestone

First Posted

Study publicly available on registry

September 4, 2025

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2026

Completed
Last Updated

September 4, 2025

Status Verified

August 1, 2025

Enrollment Period

10 months

First QC Date

August 24, 2025

Last Update Submit

August 30, 2025

Conditions

Oral Mucosal GraftLabial GraftFemaleUrethroplasty

Outcome Measures

Primary Outcomes (1)

  • Urine flow rate

    Urine flow rate will be recorded.

    6 months post-procedure

Study Arms (2)

Group 1

EXPERIMENTAL

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

Procedure: Oral mucosal graft

Group 2

EXPERIMENTAL

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

Procedure: Labial graft

Interventions

Oral mucosal graftPROCEDURE

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

Group 1
Labial graftPROCEDURE

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

Group 2

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsFemale undergoing urethroplasty
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Female patients with traumatic urethral stricture.
  • Female patients with systemic contraindications of surgery like bleeding disorders.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tanta University

Tanta, El-Gharbia, 31527, Egypt

RECRUITING

Central Study Contacts

Elmaadawy I Elmaadawy, MD

CONTACT

00201060245430Mohamed.elmaadawy@med.tanta.edu.eg

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer of Urology, Faculty of Medicine, Tanta University, Tanta, Egypt.

Study Record Dates

First Submitted

August 24, 2025

First Posted

September 4, 2025

Study Start

February 26, 2025

Primary Completion

January 1, 2026

Study Completion

January 1, 2026

Last Updated

September 4, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will share

The data will be available upon a reasonable request from the corresponding author after the end of study for one year.

Shared Documents
STUDY PROTOCOL
Time Frame
After the end of study for one year.
Access Criteria
The data will be available upon a reasonable request from the corresponding author.

Locations

EG(1)