This multicenter study shows that sacral neuromodulation had sustained efficacy and quality of life improvements, and an acceptable safety profile through 5 years in subjects with overactive bladder.
Aims: This prospective, randomized, multicenter trial evaluated the 6-month success rate of sacral neuromodulation (SNM) with InterStim 1 Therapy versus standard medical therapy (SMT) for overactive bladder (OAB). Methods: 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. Results: 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 ¼ 0.02). In the as treated analysis, OAB therapeutic success was 76% for SNM and 49% for SMT (P ¼ 0.002). The SNM group showed significant improvements in quality of life versus the SMT group (all P < 0.001) and 86% of SNM subjects reported improved or greatly improved urinary symptom interference score at 6 months, compared to 44% for SMT subjects. The device-related adverse event rate was 30.5% and the medication-related adverse event rate was 27.3%. Conclusions: This study demonstrates superior objective and subjective success of SNM compared to SMT. SNM is shown to be a safe and effective treatment for OAB patients with mild to moderate symptoms. Neurourol. Urodynam. 34:224-230, 2015. # 2014 Wiley Periodicals, Inc.
Aims: This prospective, multicenter post-approval study evaluated the success rate of sacral neuromodulation (SNM) with the InterStim 1 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. Methods: 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. Results: 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 AE 2.7 leaks/day, UF subjects had 12.6 AE 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 AE 2.7 leaks/day; UF subjects had a mean reduction of 5.1 AE 4.1 voids/day (both P < 0.0001). Subjects showed significant improvement from baseline in all measures of ICIQ-OABqol (all P < 0.0001). 80% of subjects reported improved changes in their urinary symptom interference at 12 months. Device-related adverse events occurred in 16% (56/340) of subjects during test stimulation and 30% (82/272) of subjects post-implant. Conclusions: This multicenter study shows SNM is safe and effective and results in improved outcomes through 12 months in subjects with OAB symptoms, without requiring failure of all medications. Neurourol. Urodynam. 35:246-251, 2016.
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