Urethral Stricture, MaleNCT05918315
Comparison Between Two Techniques Used in Treatment of Long Anterior Urethral Stricture
A study testing Buccal mucosa substitution urethroplasty in people with Urethral Stricture, Male, run by Sohag University at 1 site in Egypt.
Trial summary
To evaluate dorsolateral and dorsal approach urethroplasty in treatment of anterior urethral stricture by using buccal mucosal graft as regard voiding and sexual outcomes. Read more about this study
- Who is it for?
- Ages 16 to 80 years, men only
- Conditions the study is for
- Urethral Stricture, Male
- What is being tested?
- Buccal mucosa substitution urethroplasty
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- Aug 2023to May 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 16 to 80 years
- Men only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- long anterior urethral stricture
Who cannot join
- children.
- Recurrent stricture
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Sohag university
Sohag, Faculty of Medicine, 82511
Hosny F Omar, Master, +201020075954, hosny.ahmed@med.sohag.edu.eg
About this study
Official title: Dorsolateral Versus Dorsal Approach Urethroplasty for Managing Long Anterior Urethral Stricture.
To evaluate dorsolateral and dorsal approach urethroplasty in treatment of anterior urethral stricture by using buccal mucosal graft as regard voiding and sexual outcomes.
Read the detailed description
At the Department of Urology, Sohag university Hospital, both techniques of dorsolateral and dorsal approach urethroplasty in treatment of anterior urethral stricture by using buccal are used in repair of long stricture anterior urethra.Therefore, our data can be used as a source for the comparative analysis of these two Buccal mucosa graft urethroplasty techniques.This study aimed to compare these procedures to determine their advantages and disadvantages, as regard voiding ,sexual function and quality of life after the surgery.
- Conditions
- Urethral Stricture, Male
- Being tested
- Buccal mucosa substitution urethroplasty
- Medical subject headings
- Urethral Stricture
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Buccal mucosa substitution urethroplastyProcedure or surgery
Use of buccal mucosa as a substitution for urethroplasty
| Study group | Role | What they receive |
|---|---|---|
| Dorsolateral approach urethroplasty | Active comparator | Use of dorsolateral(Kulkarni technique) urethroplasty. Receives: Procedure: Buccal mucosa substitution urethroplasty |
| Dorsal approach urethroplasty | Active comparator | Use of dorsal (Barbagli technique) urethroplasty Receives: Procedure: Buccal mucosa substitution urethroplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
Voiding function
Postoperative Q max
Measured: 2 months after catheter removal
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2023
- Study startAug 2023 (estimated)
- Primary completionJul 2024 (estimated)
- Study completionMay 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urethral Stricture, MaleStudies of the same condition, open and under way.
- More trials run by Sohag 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
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hosny Fathallah Omar, Sohag University
- Investigators
- Ahmed M Reyad, MD, Study director, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05918315
- Sponsor's protocol ID
- Soh-Med-23-06-01MD
- Status last verified
- Jun 2023
- First submitted
- 14 Jun 2023
- Last updated
- 26 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Share collected IPD
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dorsolateral Versus Dorsal Approach Urethroplasty for Managing Long Anterior Urethral Stricture.
- ClinicalTrials.gov ID
- NCT05918315
- Acronym / sponsor ID
- Soh-Med-23-06-01MD
- Conditions
- Urethral Stricture, Male
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- Aug 2023 (estimated)
- Primary completion
- Jul 2024 (estimated)
- Study completion
- May 2025 (estimated)
- First posted
- 26 Jun 2023 (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.
To evaluate dorsolateral and dorsal approach urethroplasty in treatment of anterior urethral stricture by using buccal mucosal graft as regard voiding and sexual outcomes.
Detailed description
At the Department of Urology, Sohag university Hospital, both techniques of dorsolateral and dorsal approach urethroplasty in treatment of anterior urethral stricture by using buccal are used in repair of long stricture anterior urethra.Therefore, our data can be used as a source for the comparative analysis of these two Buccal mucosa graft urethroplasty techniques.This study aimed to compare these procedures to determine their advantages and disadvantages, as regard voiding ,sexual function and quality of life after the surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dorsolateral approach urethroplasty | Active comparator | Procedure: Buccal mucosa substitution urethroplastyUse of dorsolateral(Kulkarni technique) urethroplasty. |
| Dorsal approach urethroplasty | Active comparator | Procedure: Buccal mucosa substitution urethroplastyUse of dorsal (Barbagli technique) urethroplasty |
Who may qualify
- Ages
- 16 to 80 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- long anterior urethral stricture
Key exclusion criteria (2 listed)
- children.
- Recurrent stricture
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 |
|---|---|---|
| Buccal mucosa substitution urethroplastyUse of buccal mucosa as a substitution for urethroplasty | Procedure or surgery | Dorsal approach urethroplasty, Dorsolateral approach urethroplasty |
Primary outcome
Voiding function
Time frame: 2 months after catheter removal
Postoperative Q max
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2023.
- Individual participant dataSharing planned: Yes. Share collected IPD
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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. This study is not recruiting at the moment.
Ahmed M Reyad, MD study director
Sohag University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Buccal mucosa substitution urethroplasty in people with Urethral Stricture, Male, run by Sohag 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 1 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: status not confirmed, as of the sponsor's last update on 26 Jun 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hosny F Omar, MD (+201020075954, hosny.ahmed@med.sohag.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Voiding function (time frame: 2 months after catheter removal). 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 26 Jun 2023.