Medtronic prospective, retrospective, and post-approval studies demonstrate that sacral neuromodulation for bladder control delivered by the InterStim™ systems are safe and effective.1,2
The studies demonstrate that this therapy effectively helps patients who have failed or could not tolerate conservative treatments for urge incontinence, urgency-frequency, or urinary retention. Specifically, sacral neuromodulation (SNM) delivered by the InterStim™ systems is proven to:
The most common adverse events experienced during clinical studies included pain at implant sites, new pain, lead migration, infection, technical or device problems, adverse change in bowel or voiding function, and undesirable stimulation or sensations. Any of these may require additional surgery or cause return of symptoms.
The safety and efficacy of the InterStim™ systems for OAB were evaluated in two phases of the InSite study. In the first, OAB patients were randomized to the InterStim™ systems or standard medical therapy (SMT) in a 1:1 ratio, and results were analyzed at 6 months. The second phase then evaluated the safety and efficacy of the InterStim™ systems after 5 years among implanted patients.
Compared to standard medical therapy
See evidence of how the efficacy of the InterStim™ systems for OAB compares to medications.
Examine data about results the InterStim™ systems achieves after 5 years.
Restored function defined as ≥50% reduction in dysfunctional voiding symptoms from baseline.
Medtronic-sponsored research. InterStimTM Therapy Clinical Summary, 2018.
Siegel S, Noblett K, Mangel J, et al. Five-year follow-up results of a prospective, multicenter study of patients with overactive bladder treated with sacral neuromodulation. The Journal of Urology 2018, 229–236.
Siegel S, Noblett K, Mangel J, et al. Results of a prospective, randomized, multicenter study evaluating sacral neuromodulation with InterStimTM therapy compared to standard medical therapy at 6-months in subjects with mild symptoms of overactive bladder. Neurourol Urodyn. 2015;34(3):224–230. doi: 10.1002/nau.22544.