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

NCT ID: NCT06056856

Last Updated: 2023-09-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-06-01

Study Completion Date

2024-08-01

Brief Summary

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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

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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.

Conditions

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Anterior Urethral Stricture, Male

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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

TREATMENT

Blinding Strategy

NONE

Study Groups

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PSG group

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

Group Type ACTIVE_COMPARATOR

Penile skin graft substituttion urethroplasty

Intervention Type PROCEDURE

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

BMG group

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

Group Type ACTIVE_COMPARATOR

Buccal Mucosal Graft substitution urethroplasty

Intervention Type PROCEDURE

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

Interventions

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Penile skin graft substituttion urethroplasty

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

Intervention Type PROCEDURE

Buccal Mucosal Graft substitution urethroplasty

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

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

5 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Al-Azhar University

OTHER

Sponsor Role lead

Responsible Party

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Mohamed Ahmed Anwar

Assistant lecturer

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ahmed Fahim, professor

Role: STUDY_DIRECTOR

Urology department, Al-Azhar university, Cairo, Egypt

Mostafa Ezzeldein, professor

Role: STUDY_CHAIR

Urology department, Al-Azhar university, Cairo, Egypt

Locations

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Al-Azhar urology department, Al-Azhar university hospitals

Cairo, , Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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Mohamed Anwar, A. lecturer

Role: CONTACT

00201155678282

Ahmed Alrefaey, lecturer

Role: CONTACT

00201149394121

Facility Contacts

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Malakah Mohamed, secretary

Role: primary

+20225107222

Samah Adel, secretary

Role: backup

00201007561116

Provided Documents

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Document Type: Study Protocol

View Document

Other Identifiers

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773

Identifier Type: -

Identifier Source: org_study_id

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