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Results of a Prospective, Randomized, Multicenter Study Evaluating Sacral Neuromodulation With InterStim Therapy Compared to Standard Medical Therapy at 6-Months in Subjects With Mild Symptoms of Overactive Bladder NEUROUROLOGY AND URODYNAMICS Siegel, S., Noblett, K., Mangel, J., Griebling, T. L., Sutherland, S. E., Bird, E. T., Comiter, C., Culkin, D., Bennett, J., Zylstra, S., Berg, K. C., Kan, F., Irwin, C. P. 2015; 34 (3): 224-230

Abstract

This prospective, randomized, multicenter trial evaluated the 6-month success rate of sacral neuromodulation (SNM) with InterStim® Therapy versus standard medical therapy (SMT) for overactive bladder (OAB).Enrolled subjects discontinued OAB medications prior to and during baseline data collection and were randomized 1:1 to SNM or SMT. Subjects had bothersome symptoms of overactive bladder (OAB) including urinary urge incontinence (=2 leaks/72?hr) and/or urgency-frequency (=8?voids/day). Subjects failed at least one anticholinergic medication, and had at least one medication not yet attempted. The primary objective was to compare OAB therapeutic success rate at 6 months between SNM and SMT.Overall, 147 subjects were randomized (70 to SNM and 77 to SMT); 93% were female and mean age was 58. The primary intent to treat analysis showed OAB therapeutic success was significantly greater in the SNM group (61%) than the SMT group (42%; P?=?0.02). In the as treated analysis, OAB therapeutic success was 76% for SNM and 49% for SMT (P?=?0.002). The SNM group showed significant improvements in quality of life versus the SMT group (all P?

View details for DOI 10.1002/nau.22544

View details for Web of Science ID 000352152900005

View details for PubMedID 24415559