Bioengineered Collagen Implant for Urethral Stricture Repair

NCT05463991 | Completed

• 1 other identifier: FIH-BCI
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

Brief Summary

The field of research for this study is tissue engineering and the utilization of a bioengineered collagen implant as a substitute biomaterial for conventional buccal mucosa in substitution urethroplasty of distal urethral strictures.

Conditions

Urethral Stricture

Outcome Measures

Primary Outcomes (1)

• Urethral patency

  A peri-urethrogram will be performed prior to catheter removal.

  four weeks post-surgery

Secondary Outcomes (2)

• Voiding symptoms

  two months up-to twenty-four months post-surgery

• Urine flow

  two months up-to twenty-four months post-surgery

Study Arms (1)

Bioengineered collagen implant

EXPERIMENTAL

Standard technique of doing a substitution urethroplasty with no modification to the surgical steps. Instead of an autologous oral bucal mucosa graft, the bioengineered collagen implant is sutured to the healty urethral area after incision of the urethra at the stricture location.

Device: Bioengineered collagen implant

Interventions

Bioengineered collagen implant DEVICE

Urethral stricture repair

Bioengineered collagen implant

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult males with urethral stricture less than 3 cm (anywhere from penile to bulbar urethra not including the membranous urethra) with existing lumen of at least 6 Fr suitable for augmentation urethroplasty. The stricture may be due to trauma or infection.

You may not qualify if:

• Known bovine collagen allergy
• Current urinary tract infection
• Chronic renal failure
• Diabeted
• Neurological diseases
• Chronic obstructive pulmonary diseases
• Sleep disturbances
• Depression
• Former cancer treatment
• Smokers
• Recurrent stricture

Sponsors & Collaborators

• Regenosca SA: lead

Study Sites (1)

University of Malaya Medical Center

Kuala Lumpur, 59100, Malaysia

Location

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

Study Officials

• Teng Aik Ong, Prof

  University of Malaya Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 14, 2022
• First Posted: July 19, 2022
• Study Start: August 15, 2022
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: April 29, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

MY (1)