Back to results

Anatomical and Functional Outcome of PSG Vs BMG for Urethral Substitution in Long Segment Anterior Urethral Strictures

Primary Purpose

Anterior Urethral Stricture, Male

Status

Recruiting

Phase

Not Applicable

Locations

Egypt

Study Type

Interventional

Intervention

Penile skin graft substituttion urethroplasty

Buccal Mucosal Graft substitution urethroplasty

About this trial

This is an interventional treatment trial for Anterior Urethral Stricture, Male focused on measuring urethral stricture, urethroplasty, BMG, PSG, penile skin

Eligibility Criteria

5 Years - undefined (Child, Adult, Older Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria: The study will include patients with long segment anterior urethral stricture (>2 cm). Exclusion Criteria: Urethro-cutaneous fistula, urethral abscess or diverticulum. A scarred and unsalvageable urethral plate or scarred perineum. Lichen sclerosis (Balanitis xerotica obliterans). Unhealthy/unavailable buccal mucosa.

Sites / Locations

Al-Azhar urology department, Al-Azhar university hospitalsRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

PSG group

BMG group

Arm Description

The group of patients who will undergo penile skin graft substitituion of long anterior urethral stricture

The group of patients who will undergo buccal mucosal graft substitituion of long anterior urethral stricture

Outcomes

Primary Outcome Measures

The degree of urethral lumen patency.

Patent urethra as evidenced by uroflowmetry and retrograde urethrography +/- urethroscopy

Secondary Outcome Measures

Lower urinary tract symptoms improvement

lower urinary tract symptoms as assessed by the international prostate symptom score, ranging from 0 to 35, where scores from 0-7 are mild, from 8-19 are moderate, from 20-35 are severe symptoms.

Erectile function assessment

sexual function as assessed by the international index of erectile function-5 questionnaire, ranging from 5-25, where 22-25 is normal, 17-21 is mild ED, 12-16 is mild to moderate ED, 8-11 is moderate ED, and 5-7 is severe ED.

Full Information

NCT ID

NCT06056856

First Posted

August 11, 2023

Last Updated

September 26, 2023

Sponsor

Al-Azhar University

1. Study Identification

Unique Protocol Identification Number

NCT06056856

Brief Title

Anatomical and Functional Outcome of PSG Vs BMG for Urethral Substitution in Long Segment Anterior Urethral Strictures

Official Title

Anatomical and Functional Outcome of Penile Skin Graft Versus Buccal Mucosal Graft for Urethral Substitution in Long Segment Anterior Urethral Strictures

Study Type

Interventional

2. Study Status

Record Verification Date

September 2023

Overall Recruitment Status

Recruiting

Study Start Date

June 1, 2022 (Actual)

Primary Completion Date

June 1, 2024 (Anticipated)

Study Completion Date

August 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Al-Azhar University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

This study aims to compare the penile skin graft and buccal mucosal graft for substitution of long anterior urethral strictures using one-sided dorsal perineal approach.

Detailed Description

Since previous studies were: Retrospective and very few were prospective randomized studies Some studies were done on lichen sclerosis cases that have an adverse effect on the PSG outcome. The follow-up duration was longer for PSG patients. Stricture length was usually longer for PSG cases. This study aims to compare the PSG and BMG for substitution of long anterior urethral strictures using one-sided dorsal perineal approach. The investigators hypothesize that: ❶ Conducting a well-designed prospective, randomized study can help identify which technique is better than the other. ❷ Using the one-side dorsal approach can improve the outcomes of both techniques and identify their advantages and disadvantages.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Anterior Urethral Stricture, Male

Keywords

urethral stricture, urethroplasty, BMG, PSG, penile skin

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

Two-arm parallel assignment. The first arm will be operated using penile skin grafts, The second arm will be operated using buccal mucosal grafts.

Masking

None (Open Label)

Allocation

Randomized

Enrollment

60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

PSG group

Arm Type

Active Comparator

Arm Description

The group of patients who will undergo penile skin graft substitituion of long anterior urethral stricture

Arm Title

BMG group

Arm Type

Active Comparator

Arm Description

The group of patients who will undergo buccal mucosal graft substitituion of long anterior urethral stricture

Intervention Type

Procedure

Intervention Name(s)

Penile skin graft substituttion urethroplasty

Intervention Description

substitution of long anterior urethral strictures using one-sided dorsal perineal approach

Intervention Type

Procedure

Intervention Name(s)

Buccal Mucosal Graft substitution urethroplasty

Intervention Description

substitution of long anterior urethral strictures using one-sided dorsal perineal approach

Primary Outcome Measure Information:

Title

The degree of urethral lumen patency.

Description

Patent urethra as evidenced by uroflowmetry and retrograde urethrography +/- urethroscopy

Time Frame

through study completion, an average of 1 year.

Secondary Outcome Measure Information:

Title

Lower urinary tract symptoms improvement

Description

lower urinary tract symptoms as assessed by the international prostate symptom score, ranging from 0 to 35, where scores from 0-7 are mild, from 8-19 are moderate, from 20-35 are severe symptoms.

Time Frame

6 months

Title

Erectile function assessment

Description

Time Frame

6 months

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

5 Years

Accepts Healthy Volunteers

Eligibility Criteria

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Mohamed Anwar, A. lecturer

Phone

00201155678282

m0anwar2005@gmail.com

First Name & Middle Initial & Last Name or Official Title & Degree

Ahmed Alrefaey, lecturer

Phone

00201149394121

urologydepartment@azhar.edu.eg

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Ahmed Fahim, professor

Organizational Affiliation

Urology department, Al-Azhar university, Cairo, Egypt

Official's Role

Study Director

First Name & Middle Initial & Last Name & Degree

Mostafa Ezzeldein, professor

Organizational Affiliation

Urology department, Al-Azhar university, Cairo, Egypt

Official's Role

Study Chair

Facility Information:

Facility Name

Al-Azhar urology department, Al-Azhar university hospitals

City

Cairo

ZIP/Postal Code

11511

Country

Egypt

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Malakah Mohamed, secretary

Phone

+20225107222

urologydepartment@azhar.edu.eg

First Name & Middle Initial & Last Name & Degree

Samah Adel, secretary

Phone

00201007561116

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

Patients' data sheet, patient consent forms through my E-mail: m0anwar2005@gmail.com

IPD Sharing Time Frame

The data will be available after 1 year, and for 2 years.

IPD Sharing Access Criteria

My e-mail: m0anwar2005@gmail.com

Learn more about this trial

Anatomical and Functional Outcome of PSG Vs BMG for Urethral Substitution in Long Segment Anterior Urethral Strictures

We'll reach out to this number within 24 hrs