Bioengineered Collagen Implant for Urethral Stricture Repair

  • STATUS
    Recruiting
  • End date
    Dec 22, 2024
  • participants needed
    5
  • sponsor
    Regenosca SA
Updated on 4 October 2022

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.

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.

Details
Condition Urethral Stricture
Treatment Bioengineered collagen implant
Clinical Study IdentifierNCT05463991
SponsorRegenosca SA
Last Modified on4 October 2022

Eligibility

Yes No Not Sure

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
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