Bioengineered Collagen Implant for Urethral Stricture Repair

Sponsor

Regenosca SA (Industry)

Overall Status

Recruiting

CT.gov ID

NCT05463991

Collaborator

(none)

Enrollment

Location

Arm

Anticipated Duration (Months)

0.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Urethral Stricture	Device: Bioengineered collagen implant	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

5 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Device Feasibility

Official Title:

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

Anticipated Study Start Date :

Jul 1, 2022

Anticipated Primary Completion Date :

Oct 1, 2022

Anticipated Study Completion Date :

Dec 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	Device: Bioengineered collagen implant Urethral stricture repair

Arm

Intervention/Treatment

Experimental: 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.

Device: Bioengineered collagen implant

Urethral stricture repair

Outcome Measures

Primary Outcome Measures

Urethral patency [four weeks post-surgery]
A peri-urethrogram will be performed prior to catheter removal.

Secondary Outcome Measures

Voiding symptoms [two months up-to twenty-four months post-surgery]
Participants are filling out the International Prostate Symptom Score (IPSS) questionnaire.
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Male

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Malaya Medical Center	Kuala Lumpur		Malaysia	59100

Sponsors and Collaborators

Regenosca SA

Investigators

Principal Investigator: Teng Aik Ong, Prof, University of Malaya Medical Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Regenosca SA

ClinicalTrials.gov Identifier:

NCT05463991

Other Study ID Numbers:

FIH-BCI

First Posted:

Jul 19, 2022

Last Update Posted:

Jul 19, 2022

Last Verified:

Jul 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Urethral Stricture

Constriction, Pathologic

Study Results

No Results Posted as of Jul 19, 2022