Oral Mucosal GraftNCT07153861
Oral Mucosal Graft Versus Labial Graft in Female Urethroplasty
A study testing Oral mucosal graft and Labial graft in people with Oral Mucosal Graft and Labial Graft, run by Tanta University at 1 site in Egypt.
Trial summary
This study aims to compare the oral versus labial graft in female urethroplasty in female urethral stricture. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Oral Mucosal Graft, Labial Graft, Female
- What is being tested?
- Oral mucosal graft and Labial graft
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 26 Feb 2025to 1 Jan 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female patients with urethral stricture.
- Female patients with non-traumatic urethral stricture.
Who cannot join
- Female patients with traumatic urethral stricture.
- Female patients with systemic contraindications of surgery like bleeding disorders.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Tanta University
Tanta, El-Gharbia, 31527
Mohamed I Elmaadawy, MD, 00201060245430, Mohamed.elmaadawy@med.tanta.edu.eg
About this study
Official title: Oral Mucosal Graft Versus Labial Graft in Female Urethroplasty: A Prospective Comparative Study
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.
- Conditions
- Oral Mucosal Graft, Labial Graft, Female, Urethroplasty
- Being tested
- Oral mucosal graft, Labial graft
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oral mucosal graftProcedure or surgery
Patients will be admitted for the surgical management by the oral mucosal graft urethroplasty with the anterior onlay technique.
Labial graftProcedure or surgery
Patients will be admitted for the surgical management by the labial graft urethroplasty with the anterior onlay technique.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Experimental | Patients will be admitted for the surgical management by the oral mucosal graft urethroplasty with the anterior onlay technique. Receives: 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. Receives: Procedure: Labial graft |
What is being measured
The primary outcome is the main question the study is designed to answer.
Urine flow rate
Urine flow rate will be recorded.
Measured: 6 months post-procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2025
- Study start26 Feb 2025
- Primary completion1 Jan 2026 (estimated)
- Study completion1 Jan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oral Mucosal GraftStudies of the same condition, open and under way.
- More trials run by Tanta UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Ibrahim Ahmed Elmaadawy, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07153861
- Sponsor's protocol ID
- 36264PR1113/2/25
- Status last verified
- Aug 2025
- First submitted
- 24 Aug 2025
- Last updated
- 4 Sep 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oral Mucosal Graft Versus Labial Graft in Female Urethroplasty: A Prospective Comparative Study
- ClinicalTrials.gov ID
- NCT07153861
- Acronym / sponsor ID
- 36264PR1113/2/25
- Conditions
- Oral Mucosal Graft, Labial Graft, Female, Urethroplasty
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 26 Feb 2025 (actual)
- Primary completion
- 1 Jan 2026 (estimated)
- Study completion
- 1 Jan 2026 (estimated)
- First posted
- 4 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Experimental | Procedure: Oral mucosal graftPatients will be admitted for the surgical management by the oral mucosal graft urethroplasty with the anterior onlay technique. |
| Group 2 | Experimental | Procedure: Labial graftPatients will be admitted for the surgical management by the labial graft urethroplasty with the anterior onlay technique. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Female patients with urethral stricture.
- Female patients with non-traumatic urethral stricture.
Key exclusion criteria (2 listed)
- Female patients with traumatic urethral stricture.
- Female patients with systemic contraindications of surgery like bleeding disorders.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Oral mucosal graftPatients will be admitted for the surgical management by the oral mucosal graft urethroplasty with the anterior onlay technique. | Procedure or surgery | Group 1 |
| Labial graftPatients will be admitted for the surgical management by the labial graft urethroplasty with the anterior onlay technique. | Procedure or surgery | Group 2 |
Primary outcome
Urine flow rate
Time frame: 6 months post-procedure
Urine flow rate will be recorded.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2025.
- Individual participant dataSharing planned: Yes. The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Oral mucosal graft and Labial graft in people with Oral Mucosal Graft and Labial Graft, run by Tanta University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Elmaadawy I Elmaadawy, MD (00201060245430, Mohamed.elmaadawy@med.tanta.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Urine flow rate (time frame: 6 months post-procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Sep 2025.