A Phase 1 Study of Human Muscle Fiber Fragment (MFF) Treatment for Urinary Incontinence
Wake Forest University
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).
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.
Eligibility
- Age range
- 18–75 years
- Sex
- Female
- Healthy volunteers
- No
Inclusion Criteria: * Adult female patients who are not pregnant or lactating/breast-feeding and must be either not sexually active, surgically sterilized, or must be practicing an effective method of birth control as determined by the investigator * Patients between the ages of 18 and 75 years * Patients with positive diagnosis of urinary incontinence due to sphincter insufficiency caused by acquired (e.g., stress urinary incontinence) and/or congenital conditions. * Patients with cystometric capacity of bladder \> 100 ml * Patients with normal renal function * Patients with a history of pri…
Interventions
- OtherAutologous Muscle Fiber Fragments
Autologous muscle fiber fragments administered via a single direct injection into the bladder neck sphincter region
Location
- Wake Forest Urology ClinicWinston-Salem, North Carolina