InterStim™ systems have been implanted in over 325,000 patients*, and evaluated in more than 1,000 published clinical articles, including long-term (5-year) data for urinary incontinence, retention, and faecal incontinence.1-3VIEW PRODUCTS
With the InterStim™ systems, the implanted neurostimulator and lead electrically stimulate the sacral nerve. This is thought to normalise neural communication between the bladder and brain and between the bowel and brain.4,5 Unlike oral medications that target the muscular component of bladder control, the InterStim™ systems offer control of symptoms through direct modulation of the nerve activity.4,5
One key advantage of this therapy is that it can be tested for potential success prior to implantation. The evaluation provides an opportunity to find out whether adequate symptom reduction is achieved. Complications can occur with the evaluation, including tissue damage, infection, and technical problems with the device. Patients should be instructed on operating the programmer and given precautions related to the evaluation.
The most common adverse events experienced during clinical studies of patients with SNM 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.
* Data from InterStim Sales Analysis. Medtronic, Inc. April 2020.
** Restored bladder function defined as ≥50% reduction in dysfunctional voiding symptoms from baseline. Restored bowel function is defined as ≥50% reduction in chronic fecal incontinence episodes.
Siegel, S. et al. Five-Year Followup Results of a Prospective, Multicenter Study of Patients with Overactive Bladder Treated with Sacral Neuromodulation. J. Urol. 199, 229–236 (2018).
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.
van Kerrebroeck PE, van Voskuilen AC, Heesakkers JP et al. Results of sacral neuromodulation therapy for urinary
voiding dysfunction: outcomes of a prospective, worldwide clinical study. J Urol. 2007 Nov;178(5):2029-34.
Leng WW, Chancellor MB. How sacral nerve stimulation neuromodulation works. Urol Clin North Am. 2005;32:11-18.
Patton V, Wiklendt L, Arkwright JW, Lubowski DZ, Dinning PG. The effect of sacral nerve stimulation on distal colonic motility in patients with fecal incontinence. Br J Surg. 2013;100:959–968.
Yeaw J, Benner J, Walt JG, et al. Comparing adherence and persistence across 6 chronic medication classes. J Manag Care Pharm. 2009;15(9):724-736.
Yu, Y. F., Nichol, M. B., Yu, A. P. & Ahn, J. Persistence and Adherence of Medications for Chronic Overactive Bladder/Urinary Incontinence in the California Medicaid Program. Value Heal. 8, 495–505 (2005).
Gormley EA, Lightner DJ, Burgio KL, et al. Diagnosis and treatment of overactive bladder (non-neurogenic) in adults: AUA/SUFU guideline. American Urological Association (AUA). J Urol. 2015 May;193(5):1572-80.
Medtronic InterStim Therapy Clinical Summary, 2018.
Matzel K.E. (2017) Fecal Incontinence. In: Herold A., Lehur PA., Matzel K., O’Connell P. (eds) Coloproctology. European Manual of Medicine. Springer, Berlin, Heidelberg. DOI 10.1007/978-3-662-53210-2_9
See the device manual for detailed information regarding the instructions for use, indications, contraindications, warnings, precautions, and potential adverse events. If using an MRI SureScan® device, see the MRI SureScan® technical manual before performing an MRI. For further information, contact your local Medtronic representative and/or consult the Medtronic website at medtronic.eu website
For applicable products, consult instructions for use on www.medtronic.com/manuals.
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