Back to resultsComparison Between Two Techniques Used in Treatment of Long Anterior Urethral Stricture
Primary Purpose
Urethral Stricture, Male
Status
Not yet recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Buccal mucosa substitution urethroplasty
Sponsored by
About this trial
This is an interventional treatment trial for Urethral Stricture, Male
Eligibility Criteria
Inclusion Criteria: long anterior urethral stricture Exclusion Criteria: children. Recurrent stricture
Sites / Locations
- Sohag university
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Dorsolateral approach urethroplasty
Dorsal approach urethroplasty
Arm Description
Use of dorsolateral(Kulkarni technique) urethroplasty.
Use of dorsal (Barbagli technique) urethroplasty
Outcomes
Primary Outcome Measures
Voiding function
Postoperative Q max
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05918315
Brief Title
Comparison Between Two Techniques Used in Treatment of Long Anterior Urethral Stricture
Official Title
Dorsolateral Versus Dorsal Approach Urethroplasty for Managing Long Anterior Urethral Stricture.
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
August 2023 (Anticipated)
Primary Completion Date
July 2024 (Anticipated)
Study Completion Date
May 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sohag University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urethral Stricture, Male
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Dorsolateral approach urethroplasty
Arm Type
Active Comparator
Arm Description
Use of dorsolateral(Kulkarni technique) urethroplasty.
Arm Title
Dorsal approach urethroplasty
Arm Type
Active Comparator
Arm Description
Use of dorsal (Barbagli technique) urethroplasty
Intervention Type
Procedure
Intervention Name(s)
Buccal mucosa substitution urethroplasty
Intervention Description
Use of buccal mucosa as a substitution for urethroplasty
Primary Outcome Measure Information:
Title
Voiding function
Description
Postoperative Q max
Time Frame
2 months after catheter removal
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
long anterior urethral stricture
Exclusion Criteria:
children.
Recurrent stricture
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hosny F Omar, MD
Phone
+201020075954
Email
hosny.ahmed@med.sohag.edu.eg
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ahmed M Reyad, MD
Organizational Affiliation
Sohag university hospital
Official's Role
Study Director
Facility Information:
Facility Name
Sohag university
City
Sohag
State/Province
Faculty Of Medicine
ZIP/Postal Code
82511
Country
Egypt
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hosny F Omar, Master
Phone
+201020075954
Email
hosny.ahmed@med.sohag.edu.eg
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Share collected IPD
IPD Sharing Time Frame
6 months after publication
Learn more about this trial
Comparison Between Two Techniques Used in Treatment of Long Anterior Urethral Stricture
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