CLINICAL OUTCOMES: BLADDER CONTROL Sacral neuromodulation

CLINICAL EFFICACY FOR BLADDER CONTROL

Medtronic prospective, retrospective, and post-approval studies demonstrate that Sacral Neuromodulation for Bladder Control delivered by the InterStim™ system is safe and effective.1

The studies demonstrate that Sacral Neuromodulation effectively helps patients who have failed or could not tolerate conservative treatments for urge incontinence, urgency-frequency, or urinary retention.


PROVEN LONG-TERM CONTROL

Sacral Neuromodulation delivered by the InterStim system is proven to:

  • Restore function 1,2
  • Provide long-term control at 5 years 1,3
  • Significantly improve quality of life 1,4

Learn more about the clinical outcomes and success below.


SUSTAINED QUALITY OF LIFE IMPROVEMENTS

The InterStim™ system is the only Sacral Neuromodulation (SNM) product with 5-year clinical data demonstrating sustained, long-term efficacy and quality of life improvements for patients suffering from overactive bladder.3

Bar chart showing SNM results sustained at 5 years

  • 3 times improvement in quality of life than what is considered clinically significant 5†
  • 45% of UI subjects had complete continence at 5 years*

Safety
There were no unanticipated adverse device effects. Most adverse events (AE) were minor and could be treated with non-invasive measures. The most common adverse events were: undesirable change in stimulation; implant site pain; and therapeutic product ineffective.

* Numbers reflect completers analysis defined as patients with diary data at baseline and 5 years. Clinical success was 67% at 5 years using the modified completers analysis (subjects who either had a baseline and 5-year evaluation or withdrew early due to device-related reasons and are considered failures).

**Response was defined as defined as ≥ 50% improvement in average leaks or voids/day or a return to normal voiding (<8 voids/day).

† Minimally Important Difference (MID)= 10Pts

Superior Efficacy vs. Medications

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  symptoms of OAB.4

Graph Showing Efficacy of Sacral Neuromodulation vs. Medications at 6 Months

Numbers reflect as treated results, defined as subjects with diary data at baseline and 6 months (p=0.002). Intent to treat results, which include all randomized subjects, are 61% for SNM and 42% for SMT (p=0.02).

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. No serious device- or medication-related adverse events were reported.


Greater Quality of Life compared to Medications

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 symptoms of OAB.4

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

Graph Showing Quality of Life Improvement at 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.


5-Year Study Shows Sustained Efficacy

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 Incontinence1

  • 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

Graph Showing 5-Year Efficacy of Sacral Neuromodulation for Urge Incontinence

Urgency Frequency1

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

Graph Showing 5-Year Efficacy of Sacral Neuromodulation for Urgency Frequency

Urinary Retention1

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

Graph Showing 5-Year Efficacy of Sacral Neuromodulation for Urinary Retention

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 2018 for detailed information regarding the study results.


Adverse Events

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.

*

P<0.001. Improvements represent mean change compared with baseline.

59% in evaluable patient population (n=61) and 37% in intent-to-treat population (n=96)

71% in evaluable patient population (n=49) and 42% in intent-to-treat population (n=84)

§

56% in evaluable patient population (n=18) and 40% in intent-to-treat population (n=25)

||

78% in evaluable patient population (n=23) and 58% in intent-to-treat population (n=31)

1

Medtronic-sponsored research. InterStim™ Therapy Clinical Summary, 2018.

2

Chancellor MB, Chartier-Kastler EJ. Principles of sacral nerve stimulation (SNS) for the treatment of bladder and urethral sphincter dysfunctions. Neuromodulation. 2000;3(1):15-26.

3

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

4

Siegel S, Noblett K, Mangel J, et al. Results of a prospective, randomized, multicenter study evaluating sacral neuromodulation with InterStim™ therapy compared to standard medical therapy at 6-months in subjects with mild symptoms of overactive bladder. Neurourol Urodyn. 2015;34(3):224–230. doi: 10.1002/nau.22544

5

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.