Bioengineered Collagen Implant for Urethral Stricture Repair

April 23, 2026 updated by: Regenosca SA

Bioengineered Collagen Scaffold Implant as an Alternative to Conventional Buccal Mucosa for Substitution Urethroplasty of Distal Urethral Strictures. - A Pilot Stud

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Urethral stricture is defined as the abnormal narrowing of the urethral lumen in the area of the corpus spongiosum. A stricture is the result of ischemic spongiofibrosis manifesting as scar tissue in the corpus spongiosum. Long-term consequences are chronic fistulation through the skin, recurrent sepsis, bladder stones, obstructive uropathy, obstructive nephropathy, and finally renal failure.

Current available surgical techniques for urethral stricture repair require harvesting of grafts from autologous sites resulting in additional risks of complications at the tissue harvest site and additional pain to the patient.

The hypothesis of this study is that the developed bioengineered collagen implant can be used as an alternative biomaterial to buccal mucosa for substitution urethroplasty in urethral stricture patients.

Study Type

Interventional

Enrollment (Actual)

5

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Malaysia
      • Kuala Lumpur, Malaysia, 59100
        • University of Malaya Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

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.

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Device Feasibility
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Bioengineered collagen implant
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
Urethral stricture repair

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Urethral patency
Time Frame: four weeks post-surgery
A peri-urethrogram will be performed prior to catheter removal.
four weeks post-surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Voiding symptoms
Time Frame: two months up-to twenty-four months post-surgery
Participants are filling out the International Prostate Symptom Score (IPSS) questionnaire.
two months up-to twenty-four months post-surgery
Urine flow
Time Frame: two months up-to twenty-four months post-surgery
Participants are undergoing an uroflowmetry. This test measures the volume of urine released from the body, the speed with which it is released, and how long the release takes.
two months up-to twenty-four months post-surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Regenosca SA

Investigators

  • Principal Investigator: Teng Aik Ong, Prof, University of Malaya Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 15, 2022

Primary Completion (Actual)

December 31, 2025

Study Completion (Actual)

December 31, 2025

Study Registration Dates

First Submitted

July 14, 2022

First Submitted That Met QC Criteria

July 14, 2022

First Posted (Actual)

July 19, 2022

Study Record Updates

Last Update Posted (Actual)

April 29, 2026

Last Update Submitted That Met QC Criteria

April 23, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FIH-BCI

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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