Bioengineered Collagen Implant for Urethral Stricture Repair

Regenosca

Status: Enrolling

Conditions: Urethral Stricture

Treatments: Device: Bioengineered collagen implant

Study type: Interventional

Funder types: Industry

Identifiers

NCT05463991

FIH-BCI

Details and patient eligibility

About

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.

Full 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.

Enrollment: 5 estimated patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Device Feasibility

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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5 participants in 1 patient group

Bioengineered collagen implant

Experimental group

Description:

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.

Treatment:

Device: Bioengineered collagen implant