SUPERIOR EFFICACY TO SMT

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

Medtronic chart comparing sacral neuromodulation and SMT.

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.

GREATER QUALITY OF LIFE

  

Medtronic chart comparing the quality of life with sacral neuromodulation and SMT.
Medtronic chart comparing the quality of life with sacral neuromodulation and SMT.

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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Anticholinergic/antimuscarinic.

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.

1

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.

2

Coyne KS, et al. 2006. Determining the importance of change in the OAB-Q. J Urol. 176:627-32.