The InterStim™ system is the only sacral neuromodulation (SNM) product with five-year clinical data demonstrating sustained, long-term efficacy and quality of life improvements for patients suffering from overactive bladder (OAB).1
There were no unanticipated adverse device effects. The most common AEs were: undesirable change in stimulation (22%, 60/272); implant site pain (15%, 40/272); and therapeutic product ineffective (13%, 36/272).
Following are data from an additional post-approval, five-year, non-randomized, multicenter study showing sustained efficacy of Sacral Neuromodulation delivered by the InterStim™ system for patients with urge incontinence, urgency-frequency, or urinary retention.
This study provided data on the long-term effects of sacral neuromodulation delivered by the InterStim™ system for the treatment of urinary urge incontinence, urinary urgency-frequency, and urinary retention in patients who had failed or could not tolerate more conservative treatments. The study took place at centers in the United States, Canada, and Europe.
56% of urgency-frequency patients achieved ≥50% increase in volume voided/void and improved degree of urgency.||
78% of urinary retention patients achieved ≥50% reduction in volume/catheterization.§
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.
For additional safety information, please refer to Indications, Safety, and Warnings.
Therapeutic success defined as ≥ 50% improvement.
Numbers reflect completers analysis, which includes all implanted subjects with diary data at baseline and at each follow-up. Clinical success was 83% at 12 months. 76% at 36 months and 67% at 5 years using the modified completers analysis (subjects who either had baseline and follow-up evaluation or withdrew early due to device-related reasons and are considered failures).
Minimally Important Difference (MID) = 10Pts.
Response was defined as ≥ 50% improvement in average leaks or voids/day or a return to normal voiding (<8 voids/day).
Clinical trial design: multicenter, non-randomized, post-approval study assessed the long-term effects of sacral nerve stimulation. 152 patients were implanted with the InterStimTM system and followed through 5 years post-implant. Primary assessments based on patients’ voiding diaries. Sensitivity analysis accounted for patients missing follow-up visits, or failing to provide a voiding diary during a follow-up visit (i.e., lost to follow-up rate).
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. The Journal of Urology 2018;Volume 199(1), 229–236.
Van Kerrebroeck P, et al. Results of sacral neuromodulation therapy for urinary voiding dysfunction: outcomes of a prospective, worldwide clinical study. Journal of Urology. 2007;178:2029-2034.
Medtronic-sponsored research. InterStimTM Therapy Clinical Summary, 2018.
Coyne KS, Matza LS, Thompson CL, Kopp ZS, Khullar V. Determining the importance of change in the overactive bladder questionnaire. J Urol. 2006;176(2):627-632.