Anterior Urethral Stricture, MaleNCT06056856
Anatomical and Functional Outcome of PSG Vs BMG for Urethral Substitution in Long Segment Anterior Urethral Strictures
A study testing Penile skin graft substituttion urethroplasty and Buccal Mucosal Graft substitution urethroplasty in people with Anterior Urethral Stricture, Male, run by Al-Azhar University at 1 site in Egypt.
Trial summary
This study aims to compare the penile skin graft and buccal mucosal graft for substitution of long anterior urethral strictures using one-sided dorsal perineal approach. Read more about this study
- Who is it for?
- Ages 5 years and older, men only
- Conditions the study is for
- Anterior Urethral Stricture, Male
- What is being tested?
- Penile skin graft substituttion urethroplasty and Buccal Mucosal Graft substitution urethroplasty
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jun 2022to 1 Aug 2024
- 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 5 years and older
- Men only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- The study will include patients with long segment anterior urethral stricture (>2 cm).
Who cannot join
- Urethro-cutaneous fistula, urethral abscess or diverticulum.
- A scarred and unsalvageable urethral plate or scarred perineum.
- Lichen sclerosis (Balanitis xerotica obliterans).
- Unhealthy/unavailable buccal mucosa.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Al-Azhar urology department, Al-Azhar university hospitals
Cairo, 11511
Malakah Mohamed, secretary, +20225107222, urologydepartment@azhar.edu.eg
Samah Adel, secretary, 00201007561116
About this study
Official title: Anatomical and Functional Outcome of Penile Skin Graft Versus Buccal Mucosal Graft for Urethral Substitution in Long Segment Anterior Urethral Strictures
This study aims to compare the penile skin graft and buccal mucosal graft for substitution of long anterior urethral strictures using one-sided dorsal perineal approach.
Read the detailed description
Since previous studies were:
- Retrospective and very few were prospective randomized studies
- Some studies were done on lichen sclerosis cases that have an adverse effect on the PSG outcome.
- The follow-up duration was longer for PSG patients.
- Stricture length was usually longer for PSG cases.
This study aims to compare the PSG and BMG for substitution of long anterior urethral strictures using one-sided dorsal perineal approach.
The investigators hypothesize that:
❶ Conducting a well-designed prospective, randomized study can help identify which technique is better than the other.
❷ Using the one-side dorsal approach can improve the outcomes of both techniques and identify their advantages and disadvantages.
- Conditions
- Anterior Urethral Stricture, Male
- Being tested
- Penile skin graft substituttion urethroplasty, Buccal Mucosal Graft substitution urethroplasty
- Keywords
- urethral stricture, urethroplasty, BMG, PSG, penile skin
- Medical subject headings
- Urethral Stricture
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Penile skin graft substituttion urethroplastyProcedure or surgery
substitution of long anterior urethral strictures using one-sided dorsal perineal approach
Buccal Mucosal Graft substitution urethroplastyProcedure or surgery
substitution of long anterior urethral strictures using one-sided dorsal perineal approach
| Study group | Role | What they receive |
|---|---|---|
| PSG group | Active comparator | The group of patients who will undergo penile skin graft substitituion of long anterior urethral stricture Receives: Procedure: Penile skin graft substituttion urethroplasty |
| BMG group | Active comparator | The group of patients who will undergo buccal mucosal graft substitituion of long anterior urethral stricture Receives: Procedure: Buccal Mucosal Graft substitution urethroplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
The degree of urethral lumen patency.
Patent urethra as evidenced by uroflowmetry and retrograde urethrography +/- urethroscopy
Measured: through study completion, an average of 1 year.
Secondary outcomes (2)
Lower urinary tract symptoms improvement
lower urinary tract symptoms as assessed by the international prostate symptom score, ranging from 0 to 35, where scores from 0-7 are mild, from 8-19 are moderate, from 20-35 are severe symptoms.
Measured: 6 months
Erectile function assessment
sexual function as assessed by the international index of erectile function-5 questionnaire, ranging from 5-25, where 22-25 is normal, 17-21 is mild ED, 12-16 is mild to moderate ED, 8-11 is moderate ED, and 5-7 is severe ED.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2023
- Study start1 Jun 2022
- Primary completion1 Jun 2024 (estimated)
- Study completion1 Aug 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anterior Urethral Stricture, MaleStudies of the same condition, open and under way.
- More trials run by Al-Azhar 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
- Model description
- Two-arm parallel assignment. The first arm will be operated using penile skin grafts, The second arm will be operated using buccal mucosal grafts.
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Al-Azhar University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Ahmed Anwar, Al-Azhar University
- Investigators
- Ahmed Fahim, professor, Study director, Urology department, Al-Azhar university, Cairo, EgyptMostafa Ezzeldein, professor, Study chair, Urology department, Al-Azhar university, Cairo, Egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06056856
- Sponsor's protocol ID
- 773
- Status last verified
- Sep 2023
- First submitted
- 11 Aug 2023
- Last updated
- 28 Sep 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Patients' data sheet, patient consent forms through my E-mail: m0anwar2005@gmail.com
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Anatomical and Functional Outcome of Penile Skin Graft Versus Buccal Mucosal Graft for Urethral Substitution in Long Segment Anterior Urethral Strictures
- ClinicalTrials.gov ID
- NCT06056856
- Acronym / sponsor ID
- 773
- Conditions
- Anterior Urethral Stricture, Male
- Keywords
- urethral stricture, urethroplasty, BMG, PSG, penile skin
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Al-Azhar UniversityUniversity, hospital or other
- Study start
- 1 Jun 2022 (actual)
- Primary completion
- 1 Jun 2024 (estimated)
- Study completion
- 1 Aug 2024 (estimated)
- First posted
- 28 Sep 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.
This study aims to compare the penile skin graft and buccal mucosal graft for substitution of long anterior urethral strictures using one-sided dorsal perineal approach.
Detailed description
Since previous studies were:
- Retrospective and very few were prospective randomized studies
- Some studies were done on lichen sclerosis cases that have an adverse effect on the PSG outcome.
- The follow-up duration was longer for PSG patients.
- Stricture length was usually longer for PSG cases.
This study aims to compare the PSG and BMG for substitution of long anterior urethral strictures using one-sided dorsal perineal approach.
The investigators hypothesize that:
❶ Conducting a well-designed prospective, randomized study can help identify which technique is better than the other.
❷ Using the one-side dorsal approach can improve the outcomes of both techniques and identify their advantages and disadvantages.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Two-arm parallel assignment. The first arm will be operated using penile skin grafts, The second arm will be operated using buccal mucosal grafts.
| Arm | Type | Receives |
|---|---|---|
| PSG group | Active comparator | Procedure: Penile skin graft substituttion urethroplastyThe group of patients who will undergo penile skin graft substitituion of long anterior urethral stricture |
| BMG group | Active comparator | Procedure: Buccal Mucosal Graft substitution urethroplastyThe group of patients who will undergo buccal mucosal graft substitituion of long anterior urethral stricture |
Who may qualify
- Ages
- 5 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- The study will include patients with long segment anterior urethral stricture (>2 cm).
Key exclusion criteria (4 listed)
- Urethro-cutaneous fistula, urethral abscess or diverticulum.
- A scarred and unsalvageable urethral plate or scarred perineum.
- Lichen sclerosis (Balanitis xerotica obliterans).
- Unhealthy/unavailable buccal mucosa.
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 |
|---|---|---|
| Penile skin graft substituttion urethroplastysubstitution of long anterior urethral strictures using one-sided dorsal perineal approach | Procedure or surgery | PSG group |
| Buccal Mucosal Graft substitution urethroplastysubstitution of long anterior urethral strictures using one-sided dorsal perineal approach | Procedure or surgery | BMG group |
Primary outcome
The degree of urethral lumen patency.
Time frame: through study completion, an average of 1 year.
Patent urethra as evidenced by uroflowmetry and retrograde urethrography +/- urethroscopy
2 secondary outcomes
Lower urinary tract symptoms improvement
Time frame: 6 months
Erectile function assessment
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2023.
- Individual participant dataSharing planned: Yes. Patients' data sheet, patient consent forms through my E-mail: m0anwar2005@gmail.com
Related trials for Anterior Urethral Stricture, Male
Active, not recruiting
Outcomes of Double-face Augmentation Urethroplasty
Urethral Stricture, Anterior, Urethral Stricture Disease
Recruiting
Penile Skin Versus Buccal Mucosal Graft in Augmentation Urethroplasty for Long Anterior Urethral Stricture
Penile Skin, Buccal Mucosal Graft
Active, not recruitingObservational study
Optilume Registry for Treatment of Stricture of the Anterior Urethra
Anterior Urethral Stricture, Male
Not yet recruiting
Treatment of Bulbar Urethral Strictures With Optilume Drug-Coated Balloons in an Untreated Population
Urethral Stricture, Urethral Stricture, Anterior
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 Fahim, professor study director
Urology department, Al-Azhar university, Cairo, Egypt
Mostafa Ezzeldein, professor study chair
Urology department, Al-Azhar university, Cairo, Egypt
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Penile skin graft substituttion urethroplasty and Buccal Mucosal Graft substitution urethroplasty in people with Anterior Urethral Stricture, Male, run by Al-Azhar 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 4 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 28 Sep 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 Mohamed Anwar, A. lecturer (00201155678282, m0anwar2005@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The degree of urethral lumen patency. (time frame: through study completion, an average of 1 year.). 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 28 Sep 2023.