NCT01953263 · Wake Forest University
Muscle Fiber Fragment Treatment for Urinary Incontinence
What this study is about
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).
View original scientific description
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).
Interventions
OTHER
Autologous Muscle Fiber Fragments
Autologous muscle fiber fragments administered via a single direct injection into the bladder neck sphincter region
Primary outcome measures
Incidence of treatment-related serious adverse events
Time frame: 12 months
the subject/biopsy/treatment sites will be monitored for signs of bleeding, infections, continued pain, prolonged hospitalization
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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 primary incontinence
Exclusion criteria
- 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
- Winston-Salem, North Carolina
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Apr 23, 2026 · Source of record for eligibility and locations