InterStim™ systems are safe and effective1,2,3

Medtronic prospective, retrospective, and post-approval studies demonstrate that sacral neuromodulation for bladder and bowel control delivered by the InterStim™ systems is safe and effective.1,2,3

These clinical studies demonstrate that this therapy effectively reduces symptoms of urge incontinence, urgency-frequency, non-obstructive urinary retention, and fecal incontinence when medications were ineffective. Specifically, sacral neuromodulation (SNM) delivered by the InterStim™ systems is proven to:

  • Restore function†,1,2,3
  • Provide long-term control at five years1,2,3
  • Significantly improve quality of life for overactive bladder (OAB) patients compared to medications4

The most common adverse events experienced during clinical studies included pain at implant sites, new pain, lead migration, infection, technical or device problems, adverse changes in bowel or voiding function, and undesirable stimulation or sensations. Any of these may require additional surgery or cause a return of symptoms.

Bladder control: a two-phased clinical study

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 six months.4 The second phase then evaluated the safety and efficacy of the InterStim™ systems after five years among implanted patients.1,2

Compared to standard medical therapy

See evidence of how the efficacy of the InterStim™ systems for OAB compares to medications.

View the SNM versus SMT results

Long-term results for OAB

Learn about results the InterStim™ systems achieve after five years.

View the 5-year SNM results

Bowel control: sustained success with five-year clinical data

In a prospective clinical study, InterStim™ therapy for bowel control demonstrated that 89% of bowel patients achieved clinical success at five years.†,‡,3

See the study

89%

of chronic fecal incontinence patients achieved clinical success at five years.†,‡,3

Demonstrated results

Clinical studies demonstrate that sacral neuromodulation (SNM) delivered by the InterStim™ systems is safe, effective, and may offer your patients with overactive bladder improved quality of life.1,2

Chronic fecal incontinence (FI) often causes profound emotional distress leading to social withdrawal and isolation.5 SNM therapy delivered by the InterStim™ systems may help patients that failed or could not tolerate more conservative treatments reduce their FI symptoms.1,3

Adverse events

Clinical data using the InterStim™ systems for bowel control show no unanticipated adverse device effects, no patient deaths related to the neurostimulator or therapy, and no surgical injuries during the test or implant procedures.1,3

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.2

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

Powerful. Personalized. Proven.

† Restored function defined as ≥50% reduction in dysfunctional voiding symptoms from baseline.

‡ Numbers reflect completers analysis which included patients who had complete data at baseline and at annual visits. Clinical success was 69% and complete continence was 28% in the adjusted worst-case analysis in which patients with missing data due to lack of efficacy, device or therapy-related adverse events, or death were assumed no change from baseline. If data was missing for any other reason at 5 years, the last observation was used.

  1. Medtronic InterStim Clinical Summary 2018.
  2. 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. J Urol. 2018;199(1):229–236.
  3. Hull T, Giese C, Wexner SD, Mellgren A, Devroede G, et al. Long-term durability of sacral nerve stimulation therapy for chronic fecal incontinence. Dis Colon Rectum. 2013;56:234–245.
  4. 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.
  5. Brown HW, Wexner SD, Segall MM, et al. Quality of life impact in women with accidental bowel leakage. Int J Clin Pract. 2012;66(11):1109–1116.