Comparison Between Two Techniques Used in Treatment of Long Anterior Urethral Stricture

Sponsor

Sohag University (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05918315

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

1.9

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Urethral Stricture, Male	Procedure: Buccal mucosa substitution urethroplasty	N/A

Detailed Description

At the Department of Urology, Sohag university Hospital, both techniques of dorsolateral and dorsal approach urethroplasty in treatment of anterior urethral stricture by using buccal are used in repair of long stricture anterior urethra.Therefore, our data can be used as a source for the comparative analysis of these two Buccal mucosa graft urethroplasty techniques.This study aimed to compare these procedures to determine their advantages and disadvantages, as regard voiding ,sexual function and quality of life after the surgery.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

40 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Dorsolateral Versus Dorsal Approach Urethroplasty for Managing Long Anterior Urethral Stricture.

Anticipated Study Start Date :

Aug 1, 2023

Anticipated Primary Completion Date :

Jul 1, 2024

Anticipated Study Completion Date :

May 1, 2025

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Dorsolateral approach urethroplasty Use of dorsolateral(Kulkarni technique) urethroplasty.	Procedure: Buccal mucosa substitution urethroplasty Use of buccal mucosa as a substitution for urethroplasty
Active Comparator: Dorsal approach urethroplasty Use of dorsal (Barbagli technique) urethroplasty	Procedure: Buccal mucosa substitution urethroplasty Use of buccal mucosa as a substitution for urethroplasty

Arm

Intervention/Treatment

Active Comparator: Dorsolateral approach urethroplasty

Use of dorsolateral(Kulkarni technique) urethroplasty.

Procedure: Buccal mucosa substitution urethroplasty

Use of buccal mucosa as a substitution for urethroplasty

Active Comparator: Dorsal approach urethroplasty

Use of dorsal (Barbagli technique) urethroplasty

Procedure: Buccal mucosa substitution urethroplasty

Use of buccal mucosa as a substitution for urethroplasty

Outcome Measures

Primary Outcome Measures

Voiding function [2 months after catheter removal]
Postoperative Q max

Eligibility Criteria

Criteria

Ages Eligible for Study:

16 Years to 80 Years

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

Inclusion Criteria:

long anterior urethral stricture

Exclusion Criteria:

children.
Recurrent stricture

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Sohag university	Sohag	Faculty Of Medicine	Egypt	82511

Sponsors and Collaborators

Sohag University

Investigators

Study Director: Ahmed M Reyad, MD, Sohag university hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Hosny Fathallah Omar, MD, Sohag University

ClinicalTrials.gov Identifier:

NCT05918315

Other Study ID Numbers:

Soh-Med-23-06-01MD

First Posted:

Jun 26, 2023

Last Update Posted:

Jun 26, 2023

Last Verified:

Jun 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Urethral Stricture

Constriction, Pathologic

Study Results

No Results Posted as of Jun 26, 2023