Comparison Between Two Techniques Used in Treatment of Lo... | NCT05918315

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

NCT05918315

Sponsor

Sohag University

Status

Unknown status

Last Update Posted

Jun 26, 2023Actual

Enrollment

40Estimated

Phase

Not Applicable

Conditions

Urethral Stricture, Male

Interventions

Buccal mucosa substitution urethroplasty

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

Annotation Module

Unposted Annotation

Unposted Responsible Party

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2023

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2023Estimated

Primary Completion Date

Jul 2024Estimated

Completion Date

May 2025Estimated

First Submitted Date

Jun 14, 2023

First Submission Date that Met QC Criteria

Jun 23, 2023

First Posted Date

Jun 26, 2023Actual

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

Jun 23, 2023

Last Update Posted Date

Jun 26, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

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

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.

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

40Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Buccal mucosa substitution urethroplasty	Procedure	Use of buccal mucosa as a substitution for urethroplasty	Dorsal approach urethroplasty Dorsolateral approach urethroplasty

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Voiding function	Postoperative Q max	2 months after catheter removal

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

long anterior urethral stricture

Exclusion Criteria:

children.
Recurrent stricture

Accepts Healthy Volunteers

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

16 Years

Maximum Age

80 Years

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Hosny F Omar, MD	Contact	+201020075954		hosny.ahmed@med.sohag.edu.eg

Overall Officials

Name	Affiliation	Role
Ahmed M Reyad, MD	Sohag University	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Sohag university		Sohag	Faculty of Medicine	82511	Egypt

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

Share collected IPD

Types

Study Protocol
Statistical Analysis Plan (SAP)
Clinical Study Report (CSR)

Time Frame

6 months after publication

Access Criteria

Not provided

URL

Not provided

Type	Date	Date Unknown
Release	Aug 21, 2025
Reset	Sep 9, 2025
Release	Sep 28, 2025
Reset	Oct 23, 2025

Submission Tracking

Estimated Results First Submitted Date

Aug 21, 2025

First MCP Posted Date

Not provided

Submission Infos

Release Date	Unrelease Date	Unrelease Date Unknown	Reset Date	MCP Release Number
Aug 21, 2025			Sep 9, 2025
Sep 28, 2025

Condition Browse Module

MeSH Terms

ID	Term
D014525	Urethral Stricture

Ancestor Terms

ID	Term
D014524	Urethral Obstruction
D014522	Urethral Diseases
D014570	Urologic Diseases
D052776	Female Urogenital Diseases

Browse Leaves

Not provided

Browse Branches

Not provided