NCT01953263

Muscle Fiber Fragment Treatment for Urinary Incontinence

A Phase 1 Study of Human Muscle Fiber Fragment (MFF) Treatment for Urinary Incontinence

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 10 (estimated)
• Sponsor: Wake Forest University · Academic / Other
• Sex: Female
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This study is designed to evaluate the safety of autologous muscle fiber fragments for the treatment of urinary incontinence due to incompetent outlet (bladder neck/urethra).

Detailed description

Eligible subjects with a diagnosis of urinary incontinence who give consent to take part will undergo a biopsy of the muscle from the inner thigh under anesthesia. During the same procedure, muscle fiber fragments will be obtained from the sample and then immediately delivered via target injected into the bladder neck sphincter region using an endoscopic needle via cystoscope or under ultrasound guidance. All subjects will be followed at 1 week, 6 weeks, 3 months, 6 months and 12 months post-treatment injection.

Conditions

• Urinary Incontinence

Interventions

Type	Name	Description
OTHER	Autologous Muscle Fiber Fragments	Autologous muscle fiber fragments administered via a single direct injection into the bladder neck sphincter region

Timeline

• Start date: 2016-01-01
• Primary completion: 2027-12-01
• Completion: 2027-12-01
• First posted: 2013-09-30
• Last updated: 2026-01-28

Locations

1 site across 1 country: United States