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Muscle Fiber Fragment Treatment for Urinary Incontinence | Clinical Trials | Clareo Health

RECRUITINGPHASE1/PHASE2

Muscle Fiber Fragment Treatment for Urinary Incontinence

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

NCT01953263•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).

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.

Eligibility

Age

18 - 75 years

Sex

FEMALE

Healthy Volunteers

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
+4 more criteria

Locations (1)

Wake Forest Urology Clinic

Winston-Salem, North Carolina, United States

Key Dates

Start Date

January 1, 2016

Primary Completion Date

December 1, 2027

Completion Date

December 1, 2027

Last Updated

January 28, 2026

Enrollment

ESTIMATED participants

Conditions

Urinary Incontinence

Interventions

Autologous Muscle Fiber Fragments

OTHER

Contacts

Mary-Clare Day, RN, BSN

CONTACT

336-713-1343 mday@wakehealth.edu

Gopal Badlani, MD

CONTACT

gbadlani@wakehealth.edu

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 28, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Muscle Fiber Fragment Treatment for Urinary Incontinence

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