Bioengineered Collagen Implant for Urethral Stricture Repair

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Urethral Stricture

Intervention / Treatment
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* Device: Bioengineered collagen implant


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Device Feasibility
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Bioengineered collagen implant<br>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. | Device: Bioengineered collagen implant<br>* Urethral stricture repair<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Urethral patency | A peri-urethrogram will be performed prior to catheter removal. | four weeks post-surgery | 

Secondary Outcome Measures

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