Bioengineered Collagen Implant for Urethral Stricture Repair

Urethral Stricture Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05463991
• Other study ID #: FIH-BCI
• Status: Recruiting
• Phase: N/A
• Start date: August 15, 2022
• Est. completion date: December 2024

Study information

• Verified date: October 2022
• Source: Regenosca SA
• Contact: Mattias Larsson
• Phone: +41765973705
• Email: larsson[@]regenosca.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 5
• Est. completion date: December 2024
• Est. primary completion date: October 2022
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Constriction, Pathologic
• Urethral Stricture

Intervention

Device:
• Bioengineered collagen implant
Urethral stricture repair

Locations

Country	Name	City	State
Malaysia	University of Malaya Medical Center	Kuala Lumpur

Sponsors (1)

Lead Sponsor	Collaborator
Regenosca SA

Country where clinical trial is conducted

Malaysia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Urethral patency	A peri-urethrogram will be performed prior to catheter removal.	four weeks post-surgery
Secondary	Voiding symptoms	Participants are filling out the International Prostate Symptom Score (IPSS) questionnaire.	two months up-to twenty-four months post-surgery
Secondary	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