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.