Muscle Fiber Fragment Treatment for Urinary Incontinence

This study is testing a treatment called Autologous Muscle Fiber Fragments for women with urinary incontinence (leaking urine) caused by a weak bladder outlet. This treatment involves taking a small piece of your own muscle from your thigh, processing it into fragments, and then injecting these fragments into the bladder neck sphincter region. The main goal of this study is to see how safe this treatment is by tracking any serious side effects over 12 months. You may be able to join if you are a woman between 18 and 75 years old with this type of urinary incontinence. The current recruitment status is unclear, meaning it's not specified if they are actively enrolling participants.

Study design: This is an interventional study planning to enroll 10 women. It is not specified if it is randomized or blinded.
What's involved: If you join, you will have a muscle biopsy from your thigh and an injection of the muscle fragments into your bladder neck. You will then have follow-up visits at 1 week, 6 weeks, 3 months, 6 months, and 12 months after the injection.
Compensation: Not stated in the trial record.
Follow-up: You will be followed for 12 months after receiving the treatment injection.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

Muscle Fiber Fragment Treatment for Urinary Incontinence

Recruiting

PHASE1Ages 18–75InterventionalTreatment

Wake Forest University

~10 participants

Updated 2026-04-23 on ClinicalTrials.gov

What's tested:Autologous Muscle Fiber Fragments

At a glance

Recruiting sites

1 of 1 listed site is recruiting right now

RecruitingSuspended, closed, or not yet open

What they're measuring

Incidence of treatment-related serious adverse events

Measured over 12 months

Conditions

Urinary Incontinence

Where it's being run

1 sites across 1 states

North Carolina1

Study leadership

Gopal Badlani, MD · PRINCIPAL_INVESTIGATOR · Wake Forest School of Medicine, Dept. of Urology

Who to contact

Mary-Clare Day, RN, BSN

[email protected]

336-713-1343

Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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

What this trial measures

Incidence of treatment-related serious adverse events12 months
the subject/biopsy/treatment sites will be monitored for signs of bleeding, infections, continued pain, prolonged hospitalization

Trialytics