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