PURPOSE: To assess 12-month safety and potential efficacy of Autologous Muscle Derived Cells for Urinary Sphincter Repair (AMDC-USR; Cook MyoSite, Incorporated, Pittsburgh, PA) in women with stress urinary incontinence (SUI).
MATERIALS AND METHODS: Pooled data from 2 phase I/II studies with identical patient selection criteria and outcome measures were analyzed. Enrolled patients had SUI refractory to prior treatment and no symptom improvement over the past 6 months. Patients received intrasphincteric injection of 10 (n=16), 50 (n=16), 100 (n=24), or 200 x 106 (n=24) AMDC-USR, derived from biopsies of each patient's quadriceps femoris. The primary outcome measure was safety, determined by incidence and severity of adverse events. Potential efficacy was measured by changes in 3-day voiding diaries, 24-hour pad tests, and UDI-6 and IIQ-7 scores.
RESULTS: A total of 80 patients underwent AMDC-USR injection; 72 patients completed diaries and pad tests at 12-month follow-up. No adverse events attributed to AMDC-USR product were reported. Higher dose groups tended to have greater percentages of patients with at least 50% reduction in stress leaks and pad weight at 12-month follow-up. All dose groups had statistically significant improvement in UDI-6 and IIQ-7 scores at 12-month follow-up compared to baseline.
CONCLUSIONS: AMDC-USR at doses of 10, 50, 100, and 200 x 106 cells appears safe. Efficacy data suggest a potential dose response with a greater percentage of patients responsive to higher doses.
Written by:
Peters KM, Dmochowski RR, Carr LK, Robert M, Kaufman MR, Sirls LT, Herschorn S, Birch C, Kultgen PL, Chancellor MB. Are you the author?
Beaumont Health System, Royal Oak, Michigan; Vanderbilt Medical Center, Nashville, Tennessee; Sunnybrook Health Sciences Centre, Toronto, Ontario; Foothills Medical Centre, Calgary, Alberta; MED Institute, Inc., West Lafayette, Indiana.
Reference: J Urol. 2014 Feb 25. pii: S0022-5347(14)00302-4.
doi: 10.1016/j.juro.2014.02.047
PubMed Abstract
PMID: 24582537
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