Sacral Nerve Stimulation

Overview

For patients who don't find relief or could not tolerate drug intervention, sacral nerve stimulation (InterStim^® Therapy) may be an option.

Clinical Efficacy: 12 Months

Sacral nerve stimulation (InterStim^® Therapy) works for patients with urinary control issues.*

In a clinical study, sacral nerve stimulation patients demonstrated significantly improved quality of life at 6 months. These self-reported measures included physical health status, physical functioning, physical and emotional role, pain, and mental health.¹

Clinical Success 12-month Results

79% success in incontinence²

• 45% remained completely dry
• 34% experienced ≥50% reduction in leaking

64% success in urgency-frequency

• 31% returned to normal voids (4 to 7 voids/day)
• 33% experienced ≥50% reduction in number of voids

77% success in urinary retention

• 61% eliminated use of catheters
• 16% experienced ≥50% reduction in catheterized urine volume

*Indicated for the treatment of urinary retention and the symptoms of overactive bladder, including urinary symptoms of urgency-frequency alone or in combination, in patients who have failed or could not tolerate more conservative treatments.

Clinical Study Proves Sustained Efficacy: 5 Years²

Evaluable Patient Population Sixty Month Post-implant Results

Intent-to-Treat Patient Population Sixty Month Post-implant Results

Purpose

This post-approval, non-randomized, multicenter study provided data on the long-term effects of sacral nerve stimulation (InterStim Therapy) 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 17 centers in the U.S., Canada and Europe.

Results

The study demonstrated that sacral nerve stimulation can be a long-term solution for patients with overactive bladder or non-obstructive urinary retention. Based on the subset of study subjects for whom both baseline and five-year data were available (i.e. the evaluable sample), improvement ranged from 39% to 78%, depending on the outcome assessed. If all implanted study subjects are considered (i.e. the intent-to-treat sample) and missing five-year data are imputed using baseline values (or, in the absence of baseline values, from the mean baseline of all subjects with baseline values) the results range from 28% to 58% depending on the outcome assessed.