Muscle Fiber Fragment Treatment for Urinary Incontinence

Recruiting now · Phase 1/Phase 2

Conditions studied: Urinary Incontinence

In brief

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).

Key facts

Study ID

NCT01953263

Run by

Wake Forest University

People needed

10

Starts

2016-01-01

Expected to finish

2028-12-01

Last updated by the study team

2026-04-23

Who can join

Age: 18 and older, up to 75. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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 primary incontinence

You may not qualify if…

• Patients with a history of hypercontractile bladder, non-compliant bladder, hydronephrosis or neurogenic bladder
• Patients with an active urinary tract infection as evidenced by positive urine culture
• Patients who are taking medication that affect urination such as prescription drugs, over-the-counter drugs, or dietary supplements, including herbal supplements and those taken with teas
• Patients requiring concomitant use of or treatment with immunosuppressive agents
• Patients with a history of systemic conditions, including but not limited to HIV, diabetes and chronic liver disease (including Hepatitis B or C), that the Investigator believes may jeopardize the safety of the patient to participate in the study
• Patients with evidence or diagnosis of any primary muscle disease or coagulation disorder (including concomitant anti-coagulation therapy)
• Patients who have been treated with any other investigational drug or participated in any investigational study within 30 days prior to enrollment in this study
• Patients who have been treated with any cellular therapy within 12 months prior to enrollment in this study
• Patients with urinary incontinence other than the categories being investigated
• Patients with significant (>grade 2) pelvic organ prolapse
• Patients with vaginal prolapse beyond introitus
• Patients with neurological disorders
• Patients with abnormal bladder capacity (i.e., less than 100 cc)
• Patients with abnormal urologic conditions, including post-void residual, urethral stricture and bladder neck contracture, spastic bladder, vesicoureteral reflux, bladder stones, bladder tumors, hydronephrosis, other renal impairment

Where it is running

• Wake Forest Urology Clinic — Winston-Salem, North Carolina, United States (enrolling)

Full record on ClinicalTrials.gov

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