Important Safety Information

Medtronic Bladder Control Therapy delivered by the InterStim™ system treats urinary retention (inability to completely empty the bladder) and the symptoms of overactive bladder, including urinary urge incontinence (leakage) and significant symptoms of urgency-frequency. It should be used after you have tried other treatments such as medications and behavioral therapy and they have not worked, or you could not tolerate them. This therapy is not intended for patients with a urinary blockage.

Safety and effectiveness have not been established for pregnancy and delivery; patients under the age of 16; or for patients with neurological disease origins.

Medtronic Bowel Control Therapy delivered by InterStim™ system treats chronic fecal incontinence (an accident or leaking involving stool). It should be used after you have tried other treatments such as medications and dietary modifications and they have not worked, or if you are not a candidate for them.

Safety and effectiveness have not been established for pregnancy and delivery; patients under the age of 18; or for patients with progressive, systemic neurological diseases.

Medtronic Bladder Control Therapy and Medtronic Bowel Control Therapy: You must demonstrate an appropriate response to the evaluation to be a candidate. You cannot have diathermy (deep heat treatment from electromagnetic energy) if you have an InterStim™ device.

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, interactions with certain other devices or diagnostic equipment such as MRI, undesirable changes in urinary or bowel function, and uncomfortable stimulation (sometimes described as a jolting or shocking feeling).

This therapy is not for everyone. This treatment is prescribed by your doctor. Please talk to your doctor to decide whether this therapy is right for you. Your doctor should discuss all potential benefits and risks with you. Although many patients may benefit from the use of this treatment, results may vary. For further information, please call Medtronic at 1-800-328-0810 and/or consult Medtronic’s website at www.medtronic.com.

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If bladder accidents keep you from enjoying the activities you love, you’re not alone.

Bladder or bowel incontinence?
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InterStim™ system for urinary incontinence

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Incontinence can be a serious condition, and it's not a normal part of getting older.
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The InterStim™ system is a proven treatment1–3 for overactive bladder (OAB) and non-obstructive urinary retention.
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Millions of people experience symptoms of OAB, including symptoms of urinary incontinence.4–6
Woman holding the Interstim device

What is the InterStim™
system treatment?

Start with an InterStim™ system evaluation.

  • With the InterStim™ system, you can try† the therapy for about a week before you decide whether to have a device implanted for long-term care.
  • If you and your doctor move forward, a small implant is placed just below the skin in your upper buttock.
  • Sacral nerve stimulation modulates miscommunication between the brain and bladder/bowel, which may help restore‡ function.7–10
  • Recharge-free and rechargeable device options let you and your doctor personalize the therapy to your lifestyle.

† Complications can occur with test, including movement of the wire, technical problems with the device, and some temporary pain. Your healthcare provider will give you information regarding how to operate the test device, and inform you of other precautions related to the test and activity restrictions.

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

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Not all patients will experience similar results. Talk to your doctor to see if this therapy is right for you.
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Urology issues?
There are options.

An InterStim™ system has been chosen for bowel and bladder symptoms by more than 450,000 patients.
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Still planning your life around the bathroom?

You are not alone. Talk to your doctor to find out if the InterStim™ system may be right for you.

Information on this site should not be used as a substitute for talking with your doctor. Always talk with your doctor about diagnosis and treatment information. Not all patients will experience the same results. Risks may include surgical, device, and stimulation-related complications.

  • 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.
  • Medtronic InterStim™ Therapy Clinical Summary (2018).
  • Hull T, Giese C, Wexner SD, et al. Long-term durability of sacral nerve stimulation therapy for chronic fecal incontinence. Dis Colon Rectum. 2013: 56(2):234-245.
  • Stewart WF, Van Rooyen JB, Cundiff GW, et al. Prevalence and burden of overactive bladder in the United States. World J Urol. 2003;20(6):327-336.
  • Centers for Disease Control and Prevention (CDC). National Center for Health Statistics (NCHS). National Health and Nutrition Examination Survey Data, 2024. https://www.cdc.gov/nchs/nhanes/Default.aspx. Accessed January 31, 2025.
  • US Census Bureau 2020. US adult and under-age-18 populations: 2020 census. https://www.census.gov/library/visualizations/interactive/adult-and-under-the-age-of-18-populations-2020-census.html Accessed June20, 2022.
  • Chancellor MB, Chartier-Kastler EJ. Principles of sacral nerve stimulation (SNS) for the treatment of bladder and urethral sphincter dysfunctions. Neuromod. 2000;3(1):15-26.
  • Leng WW, Chancellor MB. How sacral nerve stimulation neuromodulation works. Urol Clin North Am. 2005;32:11-18.
  • Janssen PTJ, Komen N, Melenhorst J, et al. Sacral neuromodulation for fecal incontinence: a review of the central mechanisms of action. J Clin Gastroenterol. 2017;51(8):669-676.
  • Lundby L, Moeller A, Buntzen S, et al. Relief of fecal incontinence by sacral nerve stimulation linked to focal brain activation. Dis Colon Rectum. 2011;54(3):318-323.
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