CLINICAL OUTCOMES: BLADDER CONTROL Sacral neuromodulation

Sacral Neuromodulation for Bladder Control outperforms medications, as shown in a six-month randomized study comparing Sacral Neuromodulation (SNM) to standard medical therapy (SMT) in patients with mild symptoms of OAB.¹

SNM showed 3 times greater improvement in HRQOL total quality of life over 6 months.^*

Device-related adverse events occurred in 31% of SNM patients, and medication-related adverse events occurred in 27% of SMT patients. No unanticipated adverse events were reported in SNM patients. No serious device- or medication-related adverse events were reported.

Following are data from the 12-month, randomized, multicenter study showing efficacy of Sacral Neuromodulation for patients with urge incontinence, urgency-frequency, and retention.

79% of patients with urge incontinence achieved clinical success:

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

64% of patients with urgency-frequency achieved clinical success:

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

77% of patients with urinary retention achieved clinical success:

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

In the same clinical study, patients receiving Sacral Neuromodulation 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.³

Refer to the InterStim Therapy Clinical Summary 2014 for detailed information regarding the study results.

Approximately 52% of patients experienced adverse events related to InterStim Therapy. The most common AEs were pain at neurostimulator site, new pain, suspected lead migration, infection, transient electric shock, and pain at lead site.

Following are data from the 5-year, non-randomized, multicenter study showing sustained efficacy of Sacral Neuromodulation for patients with urge incontinence, urgency-frequency, or urinary retention.

Urge Incontinence³

• 59% of urge incontinent patients achieved ≥ 50% reduction in leaks/day.^†
• 71% of those urge incontinent patients who reported heavy leaks at baseline achieved ≥ 50% reduction in leaks/day^‡

Urgency Frequency³

56% of urgency-frequency patients achieved ≥ 50% increase in volume voided/void and improved degree of urgency^§

Urinary Retention³

78% of urinary retention patients achieved ≥ 50% reduction in volume/catheterization^||

Study Purpose

This post-approval, non-randomized, multicenter 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.

Results

The study demonstrated that Sacral Neuromodulation can be a long-term solution for patients with overactive bladder or non-obstructive urinary retention.

Refer to the InterStim Therapy Clinical Summary 2014 for detailed information regarding the study results.