Recruiting

Phase 1

Phase 2

Muscle Fiber FragmentMuscle Fiber Fragment Treatment for Urinary Incontinence

Sponsor:

Wake Forest University

Code:

NCT01953263

Conditions

Urinary Incontinence

Eligibility Criteria

Sex: Female

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Autologous Muscle Fiber Fragments

Study Details

Brief 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).

Conditions

Urinary Incontinence

Study ID

NCT01953263

Start date

Jan, 2016

Status verified date

Apr, 2026

Completion date

Dec, 2028

Anticipated

Primary completion date

Dec, 2028

Anticipated

Eligibility Criteria

Sex: Female

Age: 18 - 70+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

10 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Autologous Muscle Fiber Fragments

Autologous Muscle Fiber Fragments administered via a single,direct injection into the bladder neck sphincter region

Interventions

Autologous Muscle Fiber Fragments

Autologous muscle fiber fragments administered via a single direct injection into the bladder neck sphincter region

Primary outcome measure

Incidence of treatment-related serious adverse events [ Time Frame: 12 months ]

Central Contacts and Locations

Central contacts

Mary-Clare Day, RN, BSN

336-713-1343 mday@wakehealth.edu

Gopal Badlani, MD

gbadlani@wakehealth.edu

Locations

Wake Forest Urology Clinic

Recruiting

Winston-Salem, North Carolina, United States, 27103

Contacts

Mary-Clare Day, RN, BSN

336-713-1343 mday@wakehealth.edu

Principal Investigator:

Gopal Badlani, MD

More Information

Sponsor

Wake Forest University

Last update posted

Apr 23, 2026

Last verified

Apr, 2026

Keywords

urinary incontinence, muscle fibers

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Wake Forest University on 2026-04-23.