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InterStim

Important Safety Information

Medtronic Bladder Control Therapy Delivered by The InterStim System

Evidence suggests that breakdowns in the bladder-brain communication pathway are the root cause of OAB and non-obstructive urinary retention.1-3 While other therapies focus on the bladder muscles, Medtronic therapies target the nerves, which is thought to help restore normal bladder function.*

Imaging showing the brain and urinary system

The relief you’ve been waiting for

  • Targets the nerves that control your bladder to help it function normally again
  • 85 percent of people with OAB using it achieved success in the first year4**
  • 3X greater improvements in OAB quality of life compared to medications5
  • Only therapy that lets you see if it works before you and your doctor decide
  • More than 300,000 patients have received relief as a safe, FDA-approved and minimally invasive Bladder Control Therapy

In addition to risks related to surgery, complications can include pain at the implant sites, new pain, infection, lead (thin wire) movement/migration, device problems, undesirable changes in urinary or bowel function, and uncomfortable stimulation (sometimes described as a jolting or shocking feeling). Talk with your doctor about ways to minimize these risks.

InterStim II device

Quarter shown for size comparison

Proven Results

  • 84% satisfaction among those who use it6
  • 76% of people with OAB achieved success* at 6 months compared to 49% who used medications5,†
  • The only OAB therapy that provides better relief than medications5,7,8

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.

anatomy

Is InterStim Right for You?

You may be a good candidate for Medtronic Bladder Control Therapy delivered by the InterStim system if:

  • You have significant OAB symptoms or non-obstructive urinary retention
  • You’ve tried lifestyle changes and oral medications
  • These therapies haven’t given you the relief you want

See if it Works for You

Unlike other bladder control treatments, our therapy lets you try it first. It’s called an evaluation — like a test run, not a long-term commitment.

  • Starts with a short, in-office procedure
  • Go about most of your regular activities for 3-14 days
  • Track your symptoms to see if they improve
  • Talk with your doctor about your results and find out if it’s likely to help you

Complications can occur with the evaluation, including movement of the wire, technical problems with the device, and some temporary pain. Your doctor or nurse will show you how to use the system, and inform you of any activity restrictions and other precautions related to the evaluation.

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*Success with SNM is defined as a 50% or greater reduction in your troublesome bladder symptoms.
**Numbers reflect completers analysis defined as patients with diary data at baseline and 12 months (n=220). Clinical success was 82% at 12 months using the modified completers analysis (subjects who either had a baseline and 12 month evaluation or withdrew early due to device-related reasons and are considered failures).
†. These patient groups were analyzed based on the treatment they were assigned: incomplete data was counted as ”failures.” Another analysis reported 61% of people achieved success with InterStim, compared to 42% who used medications.
1. Dasgupta R. Critchley HD, Dolan RJ, Fowler CJ. Changes in brain activity following sacral Neuromodulation for urinary retention. J Urol. 2005;174:2268-2272
2. Griffiths D, Derbyshire S, Stenger A, Resnick N. Brain control of normal and overactive bladder. J Urol. 2005;174:1862-1867.
3. Griffiths D, Tadic SD. Bladder control, urgency, and urge incontinence: evidence from functional brain imaging. Neurourol Urodyn. 2008;27(6):466-474.
4. Noblett K, Siegel S, Mangel J, et al. Results of a Prospective, Multicenter study evaluating quality of life, safety, and efficacy of sacral neuromodulation at twelve months in subjects with symptoms of overactive bladder. Neurourol Urodyn. 2014. doi:10.1002/nau.22707.
5. 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.
6. Foster RT Sr, Anoia EJ, Webster GD, Amundsen CL. In patients undergoing neuromodulation for intractable urge incontinence a reduction in 24-hr pad weight after the initial test stimulation best predicts long-term patient satisfaction. Neurourol Urodyn. 2007;26:213-217.
7. Visco A, Brubaker L, Richter HE et al. Anticholinergic Therapy vs. OnabotulinumtoxinA for Urgency Urinary Incontinence. New Engl J Med. 2012;367(19):1803-1813.
8. Peters KM, MacDiarmid SA, Wooldridge LS, et al. Randomized trial of percutaneous tibial nerve stimulation versus extended-release tolterodine: results from the overactive bladder innovative therapy trial. J Urol. 2009;182(3):1055-1061.
9. Peters KM, Carrico DJ, et al. “Randomized trial of percutaneous tibial nerve stimulation versus Sham efficacy in the treatment of overactive bladder syndrome: results from the SUmiT trial.” J Urol. 2010;183(4): 1438-1443.
10. Peters, K.M., D.J. Carrico, et al. (2013). “Percutaneous tibial nerve stimulation for the long-term treatment of overactive bladder: 3-year results of the STEP study.” J Urol. 189(6) 2194-2201.8.

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