Muscle Fiber Fragment Treatment for Urinary Incontinence

Wake Forest University (WFU)

Status and phase

Enrolling

Phase 2

Phase 1

Conditions

Urinary Incontinence

Treatments

Other: Autologous Muscle Fiber Fragments

Study type

Interventional

Funder types

Other

Identifiers

NCT01953263

IRB00025341

Details and patient eligibility

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).

Full 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.

Enrollment

10 estimated patients

Sex

Female

Ages

18 to 75 years old

Volunteers

No 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
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