Bioengineered Collagen Implant for Urethral Stricture Repair

Not Applicable

Recruiting

• Conditions: Urethral Stricture
• Interventions: Device: Bioengineered collagen implant

• Registration Number: NCT05463991
• Lead Sponsor: Regenosca SA

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.

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 Timeline

• Study First Submitted: 2022-07-14
• Study First Submitted QC: 2022-07-14
• Study First Posted: 2022-07-19
• Study Start: 2022-08-15
• Status Verified: 2022-10
• Primary Completion: 2022-10
• Last Update Submitted: 2022-10-25
• Last Update Posted: 2022-10-26
• Study Completion: 2024-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Male
• Target Recruitment: 5

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Bioengineered collagen implant	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.

Primary Outcome Measures

Name	Time	Method
Urethral patency	four weeks post-surgery	A peri-urethrogram will be performed prior to catheter removal.

Secondary Outcome Measures

Name	Time	Method
Urine flow	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.
Voiding symptoms	two months up-to twenty-four months post-surgery	Participants are filling out the International Prostate Symptom Score (IPSS) questionnaire.

Trial Locations

Locations (1)

University of Malaya Medical Center; 🇲🇾 Kuala Lumpur, Malaysia