CLINICAL OUTCOMES: BLADDER CONTROL Sacral neuromodulation

CLINICAL EFFICACY FOR BLADDER CONTROL

Medtronic prospective, retrospective, and post-approval studies demonstrate that Sacral Neuromodulation for Bladder Control delivered by the InterStim™ system is safe and effective.1,3

The studies demonstrate that Sacral Neuromodulation effectively helps patients who have failed or could not tolerate conservative treatments for urge incontinence, urgency-frequency, or urinary retention.


Adverse Events

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.

For additional safety information, please refer to Indications, Safety, and Warnings.

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Superior Efficacy vs. Medications1

Sacral Neuromodulation for Bladder Control outperforms medications, as shown in a six-month randomized study comparing Sacral Neuromodulation (SNM) to standard medical therapy (SMT) in patients with mild symptoms of OAB.1

Graph Showing Efficacy of Sacral Neuromodulation vs. Medications at 6 Months

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.

Greater Quality of Life compared to Medications1

12-Month Clinical Success3

5-Year Study Shows Sustained Efficacy3


*

P<0.001. Improvements represent mean change compared with baseline.

59% in evaluable patient population (n=61) and 37% in intent-to-treat population (n=96)

71% in evaluable patient population (n=49) and 42% in intent-to-treat population (n=84)

§

56% in evaluable patient population (n=18) and 40% in intent-to-treat population (n=25)

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78% in evaluable patient population (n=23) and 58% in intent-to-treat population (n=31)


1

Siegel S, Noblett K, Mangel J, et al. Neurourol Urodyn. Article published online: January 10, 2014 DOI:10.1002/nau.22544.

2

Coyne KS, Matza LS, Thompson CL, Kopp ZS, Khullar V. J Urol. 2006;176(2):627-632

3

Medtronic-sponsored research. InterStim Therapy Clinical Summary 2014.