NCT07088198

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2024

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2024

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

July 9, 2025

Completed
19 days until next milestone

First Posted

Study publicly available on registry

July 28, 2025

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2025

Completed
Last Updated

July 28, 2025

Status Verified

July 1, 2025

Enrollment Period

1.5 years

First QC Date

July 9, 2025

Last Update Submit

July 19, 2025

Conditions

Joshi's StepBuccal Mucosal GraftUrethroplastyObliterated Bulbar Urethral Stricture

Outcome Measures

Primary Outcomes (1)

  • Success rate

    Incidence of success rate will be recorded.

    6 months postoperatively

Secondary Outcomes (2)

  • Urine flow rate

    6 months postoperatively

  • The urethral lumen

    6 months postoperatively

Study Arms (1)

Study group

EXPERIMENTAL

Patients will undergo dorsal onlay buccal mucosal graft urethroplasty with Joshi's step

Procedure: Joshi's step

Interventions

Joshi's stepPROCEDURE

Patients will undergo dorsal onlay buccal mucosal graft urethroplasty with Joshi's step

Study group

Eligibility Criteria

Age18 Years+
Sexmale(Gender-based eligibility)
Gender Eligibility DetailsMales with primary bulbar urethral stricture
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tanta University

Tanta, El-Gharbia, 31527, Egypt

RECRUITING

Central Study Contacts

Mohamed I Elmaadawy, MD

CONTACT

00201060245430Mohamed.elmaadawy@med.tanta.edu.eg

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer of Urology, Faculty of Medicine, Tanta University, Tanta, Egypt

Study Record Dates

First Submitted

July 9, 2025

First Posted

July 28, 2025

Study Start

May 1, 2024

Primary Completion

November 1, 2025

Study Completion

November 1, 2025

Last Updated

July 28, 2025

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will share

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

Shared Documents
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.

Locations

EG(1)