Joshi's Step With Buccal Mucosal Graft Urethroplasty in N... | NCT07088198

Studies
Joshi's Step With Buccal Mucosal Graft Urethroplasty in Nearly Obliterated Bulbar Urethral Stricture

NCT07088198

Sponsor

Tanta University

Status

Recruiting

Last Update Posted

Jul 28, 2025Actual

Enrollment

50Estimated

Phase

Not Applicable

Conditions

Joshi's Step
Buccal Mucosal Graft
Urethroplasty
Obliterated Bulbar Urethral Stricture

Interventions

Joshi's step

Countries

Egypt

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2025

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 1, 2024Actual

Primary Completion Date

Nov 1, 2025Estimated

Completion Date

Nov 1, 2025Estimated

First Submitted Date

Jul 9, 2025

First Submission Date that Met QC Criteria

Jul 19, 2025

First Posted Date

Jul 28, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 19, 2025

Last Update Posted Date

Jul 28, 2025Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Mohamed Ibrahim Ahmed Elmaadawy, Lecturer of Urology, Faculty of Medicine, Tanta University, Tanta, Egypt, Tanta UniversityPrincipal Investigator

Lead Sponsor

Tanta UniversityOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

50Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Study group	Experimental	Patients will undergo dorsal onlay buccal mucosal graft urethroplasty with Joshi's step	Procedure: Joshi's step

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Joshi's step	Procedure	Patients will undergo dorsal onlay buccal mucosal graft urethroplasty with Joshi's step	Study group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Success rate	Incidence of success rate will be recorded.	6 months postoperatively

Secondary Outcomes

Measure	Description	Time Frame
Urine flow rate	Urine flow rate will be recorded.	6 months postoperatively
The urethral lumen	The urethral lumen by ascending urethrogram will be recorded.

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

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.

Accepts Healthy Volunteers

Sex

Male

Sex/Gender Based

Yes

Sex/Gender Description

Males with primary bulbar urethral stricture

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Mohamed I Elmaadawy, MD	Contact	00201060245430		Mohamed.elmaadawy@med.tanta.edu.eg

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Tanta University	Recruiting	Tanta	El-Gharbia	31527	Egypt

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

The data will be available upon a reasonable request from the corresponding author after the end of study for one year.

Types

Study Protocol

Time Frame

After the end of study for one year.

Access Criteria

The data will be available upon a reasonable request from the corresponding author.

URL

Not provided