NCT05918315

Brief 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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2023

Geographic Reach
1 country

1 active site

Status
unknown

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

First Submitted

Initial submission to the registry

June 14, 2023

Completed
12 days until next milestone

First Posted

Study publicly available on registry

June 26, 2023

Completed
1 month until next milestone

Study Start

First participant enrolled

August 1, 2023

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2024

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2025

Completed
Last Updated

June 26, 2023

Status Verified

June 1, 2023

Enrollment Period

11 months

First QC Date

June 14, 2023

Last Update Submit

June 23, 2023

Conditions

Urethral Stricture, Male

Outcome Measures

Primary Outcomes (1)

  • Voiding function

    Postoperative Q max

    2 months after catheter removal

Study Arms (2)

Dorsolateral approach urethroplasty

ACTIVE COMPARATOR

Use of dorsolateral(Kulkarni technique) urethroplasty.

Procedure: Buccal mucosa substitution urethroplasty

Dorsal approach urethroplasty

ACTIVE COMPARATOR

Use of dorsal (Barbagli technique) urethroplasty

Procedure: Buccal mucosa substitution urethroplasty

Interventions

Buccal mucosa substitution urethroplastyPROCEDURE

Use of buccal mucosa as a substitution for urethroplasty

Dorsal approach urethroplastyDorsolateral approach urethroplasty

Eligibility Criteria

Age16 Years - 80 Years
Sexmale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • long anterior urethral stricture

You may not qualify if:

  • children.
  • Recurrent stricture

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sohag university

Sohag, Faculty of Medicine, 82511, Egypt

Location

MeSH Terms

Conditions

Urethral Stricture

Condition Hierarchy (Ancestors)

Urethral ObstructionUrethral DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Study Officials

  • Ahmed M Reyad, MD

    Sohag University

    STUDY DIRECTOR

Central Study Contacts

Hosny F Omar, MD

CONTACT

+201020075954hosny.ahmed@med.sohag.edu.eg

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

June 14, 2023

First Posted

June 26, 2023

Study Start

August 1, 2023

Primary Completion

July 1, 2024

Study Completion

May 1, 2025

Last Updated

June 26, 2023

Record last verified: 2023-06

Data Sharing

IPD Sharing
Will share

Share collected IPD

Shared Documents
STUDY PROTOCOL, SAP, CSR
Time Frame
6 months after publication

Locations

EG(1)