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