CLINICAL OUTCOMES: BOWEL CONTROL Sacral neuromodulation

CLINICAL EFFICACY FOR BOWEL CONTROL

Chronic fecal incontinence often causes profound emotional distress leading to social withdrawal and isolation.1 The InterStim™ Therapy for Bowel Control Prospective Clinical Study demonstrates that Sacral Neuromodulation for Bowel Control delivered by the InterStim system is safe, effective, and may offer your patients improved quality of life.2,3

Clinical studies offer proof positive that Sacral Neuromodulation effectively helps patients, who have failed or could not tolerate more conservative treatments, gain control of their fecal incontinence symptoms.


Adverse Events

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.2,3

Most adverse events are successfully treated with medication or device reprogramming. The most common adverse events (n=120) are implant site pain, paraesthesia, implant site infection, change in sensation of stimulation, urinary incontinence, and diarrhea. The probability of the patient having surgical revision (including device replacement) within the first year is about 10%.3

For additional safety information, please refer to Indications, Safety, and Warnings.

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Proven Symptom Decline

The InterStim Therapy for Bowel Control Prospective Clinical Study demonstrates a statistically significant decline in fecal incontinence 12 months post implant.

  • 41% of patients achieve complete continence*3
  • 83% of patients achieve ≥50% reduction in incontinent episodes per week†2,3
  • 83% of patients achieve ≥50% reduction in incontinent days per week†2,3
  • 80% of patients achieve ≥50% reduction in urge incontinent episodes per week‡2,3

This study uses two statistical analyses: per-protocol analysis and intent-to-treat analysis (see below for definition). Results are similar, demonstrating a statistically significant and clinically relevant reduction in fecal incontinence severity for subjects implanted with the InterStim Therapy system (p<0.0001).

Per-protocol analysis (also referred to as completers analysis): conducted with patients who had complete data at baseline and annual follow-up visits.

Intent-to-treat analysis (also referred to as modified worst case analysis): Assumed no improvement for patients who were missing bowel diaries (tool used to measure symptom improvement from baseline) at follow-up visits, unless a subsequent bowel diary was available.

Adverse Events

Adverse events which occurred in at least 5% of patients after implantation included implant site pain, paresthesias, implant site infection, change in sensation of stimulation, urinary incontinence, and diarrhea.

More Effective Than Optimal Medical Therapy

Sustained Results, Fuller Lives


*

41% in per-protocol analysis (n=106) and 36% for intent-to-treat analysis (n=120) for complete continence

83% in per-protocol analysis (n=106) and 73% for intent-to-treat analysis (n=120) for both weekly incontinent episodes and days per week (p < 0.0001)

80% in per-protocol analysis (n=106) and 71% for intent-to-treat analysis (n=120) for urge incontinent episodes per week (p < 0.0001)

§

PNE: Peripheral Nerve Evaluation, a temporary test stimulation.


1

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.

2

Wexner SD, Coller JA, Devroede G, Hull T, McCallum R, Chan M, Ayscue JM, Shobeiri AS, Margolin D, England M, Kaufman H, Snape WJ, Mutlu E, Chua H, Pettit P, Nagle D, Madoff RD, Lerew DR, Mellgren A. Sacral nerve stimulation for fecal incontinence: results of a 120-patient prospective multicenter study. Ann Surg. 2010 Mar; 251(3):441-449.

3

Medtronic InterStim Clinical Summary (2014).

4

Tjandra JJ, Chan MKY, Yeh CH, Murray-Green C. Sacral nerve stimulation is more effective than optimal medical therapy for severe fecal incontinence: a randomized, controlled study. Dis Colon Rectum. 2008;51(5):494-502.

5

Hull T, Giese C, Wexner SD, et al. Longterm durability of sacral nerve stimulation therapy for chronic fecal incontinence. Dis Colon Rectum. 2013;56(2):234-245.

6

Hetzer F, Hahnloser D, Clavien P, Demartines N. Quality of life and morbidity after permanent sacral nerve stimulation for fecal incontinence. Archives of Surgery. 2007;142:8-13.