Joshi's StepNCT07088198
Joshi's Step With Buccal Mucosal Graft Urethroplasty in Nearly Obliterated Bulbar Urethral Stricture
A study testing Joshi's step in people with Joshi's Step and Buccal Mucosal Graft, run by Tanta University at 1 site in Egypt.
Trial summary
This study aims to evaluate the functional and surgical outcome of Joshi's step with buccal graft urethroplasty for the management of nearly obliterated bulbar urethral stricture. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Joshi's Step, Buccal Mucosal Graft, Urethroplasty
- What is being tested?
- Joshi's step
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- 1 May 2024to 1 Nov 2025
- 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
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with primary bulbar urethral stricture.
- Patients with non-traumatic bulbar urethral stricture.
- Patients with nearly obliterated bulbar urethral stricture, with the narrowest portion of the stricture is less than 1.5 cm in length.
Who cannot join
- Patients with traumatic bulbar urethral stricture.
- Patients with redo bulbar urethral stricture.
- Patients with obliterated bulbar urethral stricture.
- Patients with nearly obliterated long bulbar urethral stricture.
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: Joshi's Step With Buccal Mucosal Graft Urethroplasty in Nearly Obliterated Bulbar Urethral Stricture: A Prospective Study
This study aims to evaluate the functional and surgical outcome of Joshi's step with buccal graft urethroplasty for the management of nearly obliterated bulbar urethral stricture.
Read the detailed description
Urethroplasty is a rapidly evolving art that continually improves and reinvents itself. After a century of silence, during which the anastomotic repair was the only solution for approaching the strictured urethra, the 1990s can be considered the Renaissance period for reconstructive urology.
In 2022, Joshi and Kulkarni introduced a new step to the augmented urethroplasty, particularly in patients with extremely narrow strictures where a single augmentation was insufficient. They avoid any resection of the residual native urethral plate, marking the narrowest portion. Then, the edges of the mucosa are reapproximated with interrupted suturing in a proper non-resecting approach.
- Being tested
- Joshi's step
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Joshi's stepProcedure or surgery
Patients will undergo dorsal onlay buccal mucosal graft urethroplasty with Joshi's step
| Study group | Role | What they receive |
|---|---|---|
| Study group | Experimental | Patients will undergo dorsal onlay buccal mucosal graft urethroplasty with Joshi's step Receives: Procedure: Joshi's step |
What is being measured
The primary outcome is the main question the study is designed to answer.
Success rate
Incidence of success rate will be recorded.
Measured: 6 months postoperatively
Secondary outcomes (2)
Urine flow rate
Urine flow rate will be recorded.
Measured: 6 months postoperatively
The urethral lumen
The urethral lumen by ascending urethrogram will be recorded.
Measured: 6 months postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2025
- Study start1 May 2024
- Primary completion1 Nov 2025 (estimated)
- Study completion1 Nov 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Joshi's StepStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 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
- NCT07088198
- Sponsor's protocol ID
- 36264PR661/4/24
- Status last verified
- Jul 2025
- First submitted
- 9 Jul 2025
- Last updated
- 28 Jul 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 28 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Joshi's Step With Buccal Mucosal Graft Urethroplasty in Nearly Obliterated Bulbar Urethral Stricture: A Prospective Study
- ClinicalTrials.gov ID
- NCT07088198
- Acronym / sponsor ID
- 36264PR661/4/24
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 1 May 2024 (actual)
- Primary completion
- 1 Nov 2025 (estimated)
- Study completion
- 1 Nov 2025 (estimated)
- First posted
- 28 Jul 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 evaluate the functional and surgical outcome of Joshi's step with buccal graft urethroplasty for the management of nearly obliterated bulbar urethral stricture.
Detailed description
Urethroplasty is a rapidly evolving art that continually improves and reinvents itself. After a century of silence, during which the anastomotic repair was the only solution for approaching the strictured urethra, the 1990s can be considered the Renaissance period for reconstructive urology.
In 2022, Joshi and Kulkarni introduced a new step to the augmented urethroplasty, particularly in patients with extremely narrow strictures where a single augmentation was insufficient. They avoid any resection of the residual native urethral plate, marking the narrowest portion. Then, the edges of the mucosa are reapproximated with interrupted suturing in a proper non-resecting approach.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study group | Experimental | Procedure: Joshi's stepPatients will undergo dorsal onlay buccal mucosal graft urethroplasty with Joshi's step |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients with primary bulbar urethral stricture.
- Patients with non-traumatic bulbar urethral stricture.
- Patients with nearly obliterated bulbar urethral stricture, with the narrowest portion of the stricture is less than 1.5 cm in length.
Key exclusion criteria (4 listed)
- Patients with traumatic bulbar urethral stricture.
- Patients with redo bulbar urethral stricture.
- Patients with obliterated bulbar urethral stricture.
- Patients with nearly obliterated long bulbar urethral 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 |
|---|---|---|
| Joshi's stepPatients will undergo dorsal onlay buccal mucosal graft urethroplasty with Joshi's step | Procedure or surgery | Study group |
Primary outcome
Success rate
Time frame: 6 months postoperatively
Incidence of success rate will be recorded.
2 secondary outcomes
Urine flow rate
Time frame: 6 months postoperatively
The urethral lumen
Time frame: 6 months postoperatively
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 28 Jul 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.
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 Joshi's step in people with Joshi's Step and Buccal Mucosal 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 3 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: looking for participants now, as of the sponsor's last update on 28 Jul 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 Mohamed 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?
Success rate (time frame: 6 months postoperatively). 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 Jul 2025.