CClinicalTrials.gg
RecruitingNCT07153861Updated Sep 4, 2025

Oral Mucosal Graft Versus Labial Graft in Female Urethroplasty

An interventional study of Oral mucosal graft and Labial graft in Oral Mucosal Graft, Labial Graft and Female, sponsored by Tanta University. Recruiting at 1 site in Egypt. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-09-04.

Sponsored by Tanta University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Jan 2026, 9 months ago, but the record still lists the study as recruiting.
  • Registered 5 months after the study started (first participant enrolled Feb 2025, registered Aug 2025).
  • Started Feb 2025; still recruiting 1 year 7 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
40
Allocation
Randomized
Ages
18 Years and older
Sex
Female
01

Study summary

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

Read the 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.

02

Conditions studied

  • Oral Mucosal Graft
  • Labial Graft
  • Female
  • Urethroplasty
03

In context

Lead sponsor

Tanta University is the lead sponsor of 963 studies on the registry; 304 are open to participants now.

Of its 16 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Female patients with traumatic urethral stricture.
  • Female patients with systemic contraindications of surgery like bleeding disorders.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
40 participants (estimated)

Study arms

  • Experimental
    Group 1

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

    Procedure: Oral mucosal graft

  • Experimental
    Group 2

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

    Procedure: Labial graft

Interventions

  • ProcedureOral mucosal graft

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

  • ProcedureLabial graft

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

06

What researchers measure

Primary outcomes

  1. Urine flow rate

    Urine flow rate will be recorded.

    Time frame: 6 months post-procedure

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: Yes — The data will be available upon a reasonable request from the corresponding author after the end of study for one year.

Supporting information: Study protocol

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 4, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07153861
Lead sponsor
Tanta University
Responsible party
Mohamed Ibrahim Ahmed Elmaadawy (Lecturer of Urology, Faculty of Medicine, Tanta University, Tanta, Egypt., Tanta University) — Principal investigator
First posted
Sep 4, 2025
Start date
Feb 26, 2025
Primary completion
Jan 1, 2026 (estimated)
Completion
Jan 1, 2026 (estimated)
Last update
Sep 4, 2025

Study contacts

Elmaadawy I Elmaadawy, MD
Contact
Mohamed.elmaadawy@med.tanta.edu.eg
00201060245430

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Interested in this study?

Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.

Contact study team

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion