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Sacral neuromodulation (SNM) delivered by the InterStim™ system outperforms medications, as shown in a six-month randomized study comparing SNM to standard medical therapy (SMT) in patients with symptoms of OAB.1
Numbers reflect as treated results, defined as subjects with diary data at baseline and 6 months (p=0.002). Intent-to-treat results, which include all randomized subjects, are 61% for SNM and 42% for SMT (p=0.02).
Device-related adverse events occurred in 31% of SNM patients, and medication-related adverse events occurred in 27% of SMT patients. No unanticipated adverse events were reported. No serious device- or medication-related adverse events were reported. The most common device-related AEs were undesirable change in stimulation, implant site pain, and implant site infection.
Device-related adverse events occurred in 31% of SNM patients, and medication-related adverse events occurred in 27% of SMT patients. No unanticipated adverse events were reported in SNM patients. No serious device- or medication-related adverse events were reported. The most common device-related AEs were undesirable change in stimulation, implant site pain, and implant site infection.
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Numbers reflect as treated results, defined as subjects with diary data at baseline and six months (p=0.002). Intent to treat results, which include all randomized subjects, are 61% for SNM and 42% for SMT (p=0.02).
OAB response was defined as either ≥50% improvement in leaks/day for UI subjects or ≥50% improvement in voids/day or a return to normal voiding frequency (<8 voids/day) for urgency-frequency subjects.
Siegel S, Noblett K, Mangel J, et al. 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. Neurourol Urodyn. 2015;34:224–230. DOI: 10.1002/ nau.22544.
Coyne KS, et al. 2006. Determining the importance of change in the OAB-Q. J Urol. 176:627-32.