Penile Skin Versus Buccal Mucosal Graft in Augmentation Urethroplasty for Long Anterior Urethral Stricture

NCT07074717 | Recruiting

• 1 other identifier: 36264PR1074/1/25
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to analyze the outcomes of dorsal onlay buccal mucosal graft (BMG) and penile skin graft (PSG) urethroplasty in the management of long segment bulbar urethral stricture.

Conditions

Penile Skin; Buccal Mucosal Graft; Augmentation; Urethroplasty; Long Anterior; Urethral Stricture

Outcome Measures

Primary Outcomes (1)

• Surgical Success Rate

  Success is defined as satisfactory urinary stream with no need for further intervention (such as dilatation or DVIU) and no evidence of stricture on retrograde urethrogram during follow-up.

  9 months postoperatively

Secondary Outcomes (3)

• International Prostate Symptom Score (IPSS)

  9 months postoperatively

• Length of Urethral Stricture

  Intraoperatively

• Postoperative Complications

  9 months postoperatively

Study Arms (2)

Buccal Mucosal Graft (BMG)

EXPERIMENTAL

Participants will undergo dorsal onlay augmentation urethroplasty using a buccal mucosal graft harvested from the inner cheek. The procedure is performed under spinal or general anesthesia. Graft is sutured dorsally over the strictured urethral segment after excision of the fibrotic tissue.

Procedure: Buccal Mucosal Graft (BMG) Urethroplasty

Penile Skin Graft (PSG)

EXPERIMENTAL

Participants will undergo dorsal onlay augmentation urethroplasty using a penile skin graft harvested from the ventral surface of the penis. The hairless skin is prepared and sutured dorsally over the strictured urethral segment. The procedure is done under spinal or general anesthesia.

Procedure: Penile Skin Graft (PSG) Urethroplasty

Interventions

Buccal Mucosal Graft (BMG) Urethroplasty PROCEDURE

Urethroplasty using a buccal mucosal graft harvested from the inner cheek. The graft is dorsally onlaid to reconstruct the strictured urethral segment. The procedure is conducted under spinal or general anesthesia.

Also known as: Dorsal onlay buccal mucosal graft

Buccal Mucosal Graft (BMG)

Penile Skin Graft (PSG) Urethroplasty PROCEDURE

Urethroplasty using a penile skin graft harvested from the ventral surface of the penis. The graft is applied dorsally after excision of the fibrotic urethral segment. The surgery is performed under spinal or general anesthesia.

Also known as: Dorsal onlay penile skin graft

Penile Skin Graft (PSG)

Eligibility Criteria

• Age: 18 Months+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with long segment anterior urethral stricture that was defined as a stricture with a length of more than 1 cm with spongiofibrosis.
• Patients with previous failed urethral dilatation or direct vision internal urethrotomy (DVIU)

You may not qualify if:

• Patients with lichen sclerosus
• Patients with history of hypospadias repair
• Patients with recurrent urethral stricture after failed previous urethroplasty

Sponsors & Collaborators

• Tanta University: lead

Study Sites (1)

Tanta University

Tanta, El-Gharbia Governorate, Egypt, 31527, Egypt

RECRUITING

MeSH Terms

Conditions

Urethral Stricture

Condition Hierarchy (Ancestors)

Urethral Obstruction; Urethral Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Central Study Contacts

Mohamed I Elmaadawy, MD

CONTACT

00201060245430; Mohamed.elmaadawy@med.tanta.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of Urology, Faculty of Medicine, Tanta University, Tanta, Egypt.

Study Record Dates

• First Submitted: July 10, 2025
• First Posted: July 20, 2025
• Study Start: January 1, 2025
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: July 20, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: After the end of study for one year.
• Access Criteria: The data will be available upon a reasonable request from the corresponding author.

Locations

EG (1)