NCT05463991

Bioengineered Collagen Implant for Urethral Stricture Repair

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 5 (estimated)
• Sponsor: Regenosca SA · Industry
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Urethral Stricture

Interventions

Type	Name	Description
DEVICE	Bioengineered collagen implant	Urethral stricture repair

Timeline

• Start date: 2022-08-15
• Primary completion: 2025-09-01
• Completion: 2025-12-01
• First posted: 2022-07-19
• Last updated: 2025-09-17

Locations

1 site across 1 country: Malaysia