Results of a prospective, multicenter study evaluating quality of life, safety, and efficacy of sacral neuromodulation at twelve months in subjects with symptoms of overactive bladder NEUROUROLOGY AND URODYNAMICS Noblett, K., Siegel, S., Mangel, J., Griebling, T. L., Sutherland, S. E., Bird, E. T., Comiter, C., Culkin, D., Bennett, J., Zylstra, S., Kan, F., Berg, K. C. 2016; 35 (2): 246-251


This prospective, multicenter post-approval study evaluated the success rate of sacral neuromodulation (SNM) with the InterStim® System at 12-months. Subjects with bothersome symptoms of overactive bladder (OAB) including urinary urge incontinence (UI) or urgency-frequency (UF), who failed at least one anticholinergic medication and had at least one not tried were included.Subjects with successful test stimulation received an SNM implant. Therapeutic success (=50% improvement in average leaks/day or voids/day or a return to normal voiding frequency [<8 voids/day]) and quality of life through 12 months were evaluated for implanted subjects.Of the 340 subjects that went through test stimulation, 272 were implanted with SNM. Of these, 91% were female, mean age was 57, UI subjects had 3.1?±?2.7 leaks/day, UF subjects had 12.6?±?4.5 voids/day. The analysis which includes all implanted subjects with diary data at baseline and 12 months showed an OAB therapeutic success rate of 85% at 12 months. UI subjects had a mean reduction of 2.2?±?2.7 leaks/day; UF subjects had a mean reduction of 5.1?±?4.1 voids/day (both P?

View details for DOI 10.1002/nau.22707

View details for Web of Science ID 000370473400017

View details for PubMedID 25546568