Chronic fecal incontinence (FI) often causes profound emotional distress leading to social withdrawal and isolation.3 The InterStim™ therapy for bowel control prospective clinical study demonstrates that sacral neuromodulation (SNM) delivered by the InterStim™ system is safe, effective, and may offer your patients improved quality of life.1,2
The clinical study showed this therapy effectively helped patients who were failed by (or could not tolerate) more conservative treatments reduce their FI symptoms.
See evidence of how the efficacy of the InterStim™ system compares to optimal medical therapy (OMT).
Examine data about the results the InterStim™ system achieves after five years.
The InterStim™ therapy for bowel control prospective clinical study shows no unanticipated adverse device effects, no patient deaths related to the neurostimulator or therapy, and no surgical injuries during the test or implant procedures.1,2
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.
Wexner SD, Coller JA, Devroede G, et al. Sacral nerve stimulation for fecal incontinence: results of a 120-patient prospective multicenter study. Ann Surg. 2010 Mar;251(3):441-449.
Medtronic InterStimTM Clinical Summary, 2018.
Brown HW, Wexner SD, Segall MM, Brezoczky KL, Lukacz ES. Quality of life impact in women with accidental bowel leakage. Int J Clin Pract. 2012;66(11): 1109-1116.