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Completed

NCT Number: NCT05463991

Bioengineered Collagen Implant for Urethral Stricture Repair

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

University of Malaya Medical Center

Kuala Lumpur, 59100, Malaysia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Bioengineered collagen implant

Device

Urethral stricture repair

Primary outcomes

  1. Urethral patency

    Time frame: four weeks post-surgery

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

Secondary outcomes

  1. Voiding symptoms

    Time frame: two months up-to twenty-four months post-surgery

    Participants are filling out the International Prostate Symptom Score (IPSS) questionnaire.

  2. 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.

Sponsors and collaborators

Lead sponsor

Regenosca SA

Industry

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Jul 19, 2022
Registry last updated
Apr 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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