Patient & Visitor Alert: Because flu cases are on the rise, starting February 24, children 12 and younger will be restricted from visiting hospitals and certain inpatient facilities throughout Carolinas HealthCare System. Learn more.
Autologous Muscle Derived Cells for Stress Urinary Incontinence in Women
This study is to evaluate the safety and efficacy of a new medical procedure in which the patient's own muscle cells are collected, processed, and then re-injected into the tissues of their urinary passage. The product being tested is Cook MyoSite Autologous Muscle Derived Cells for Urinary Sphincter Repair (AMDC-USR), which is a preparation of the patient's own muscle cells that are collected, expanded, and then injected into the tissues of the urinary passage.
Who may be Eligible
Inclusion: Greater than 1 and less than 1 daily stress incontinence episode; Complaint of involuntary leakage on effort, exertion, or coughing/sneezing; Bladder capacity greater than or equal to 200 mL and PVR less than 150 mL; Low urethral hypermobility; Able to void spontaneously; Willing to use contraception/abstinence for duration of study if of child bearing potential. Exclusion: Symptoms of urge incontinence/mixed incontinence where urge predominates; SUI symptoms for less than 6 months or no previously attempted conservative treatment; Urinary incontinence of neurogenic etiology or related to congenital abnormality; Morbid obesity (BMI >35), diabetes or adult nocturnal enuresis; Treatment with investigational device or drug for incontinence within last 6 months; Surgical intervention (eg. SUI surgery, mesh removal, prolapse surgery) within last 6 months; Patient has ever been treated with cell therapy for SUI, History of cancer in pelvic organs, ureters, or kidneys or any cancer treatment in the last year; Urethral stricture, bladder neck contracture, bladder stones or moderate urethral fibrosis.