Bioengineered Collagen Implant for Urethral Stricture Repair

Last updated: September 11, 2025
Sponsor: Regenosca SA
Overall Status: Active - Recruiting

Phase

N/A

Condition

Enuresis

Peyronie's Disease

Treatment

Bioengineered collagen implant

Clinical Study ID

NCT05463991
FIH-BCI
  • Ages > 18
  • Male

Study 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.

Eligibility Criteria

Inclusion

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

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 Design

Total Participants: 5
Treatment Group(s): 1
Primary Treatment: Bioengineered collagen implant
Phase:
Study Start date:
August 15, 2022
Estimated Completion Date:
December 31, 2025

Study 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.

Connect with a study center

  • University of Malaya Medical Center

    Kuala Lumpur, 59100
    Malaysia

    Site Not Available

  • University of Malaya Medical Center

    Kuala Lumpur 1735161, 59100
    Malaysia

    Active - Recruiting

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