InterStim™ system offers sustained control for bowel control patients

Sacral neuromodulation (SNM) delivered by the InterStim™ system is an FDA-approved therapy doctors have trusted to treat chronic fecal incontinence (FI) for over 10 years. Sacral neuromodulation is recommended by the merican Society of Colon and Rectal Surgeons as a first-line surgical option for incontinent patients with or without sphincter defects.1

Proven symptom improvement for fecal incontinence (FI)

The InterStim™ therapy for bowel control prospective clinical study demonstrates a statistically significant decline in FI symptoms 12 months after implant.

  • 41% of patients achieve complete continence†,2
  • 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 that 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.

Bowel control success proven at five years4

  • 89% of bowel patients achieved clinical success at five years◊,¶,4
  • 36% of bowel patients achieved complete continence4

Study data demonstrate signifcant improvement in patient quality of life for patients with chronic FI, including physical and psychological well-being, as determined by a variety of accepted measures. Mean FIQOL component scales at each visit for patients with at least five years of follow-up (higher score indicates better quality of life).

InterStim demonstrated sustained long-term efficacy3,4 

■ Completer analysis (P < 0.0001) Patients who had complete data at baseline and at annual visits.
■ Modified worst case analysis (P < 0.0001) Patients missing data at this visit were assumed no change from baseline unless subsequent data was available.
■ Adjusted worst case analysis (P < 0.0001) Patients missing data due ti ack of efficacy, device or therapy-related adverse events, or death were assumed no change from baseline. If data was missing for any other reason at 5 years, the last observation was used.

The most common adverse events through five years (≥ 5% of patients, n=120) are implant site pain, parasthesia, change in sensation of stimulation, implant site infection, urinary incontinence, neurostimulator battery depletion, diarrhea, pain in extremity, undesirable change in stimulation, and buttock pain.1

Quality of life improvements using the InterStim™ systems

A study by Hetzer et al. demonstrated significant improvement across all QOL scores. Sacral neuromodulation delivered by the InterStim™ systems significantly improves median Wexner scores at six months (69%, p<0.001). Patients showed a reduction of incontinence symptoms and significantly enhancing QOL, including their social life.5

Sacral neuromodulation delivered by the InterStim™ system significantly improves generic and incontinence-specific QOL at six-month follow-up:5

  • SF-36 QOL Questionnaire: scores improve in all eight categories and significantly improve for physical functioning, social function, mental health, and vitality (p<0.05).
  • Gastrointestinal QOL Index Score: median preoperative score improves from a preoperative score of 96 to a postoperative score of 107 (0-144 rated, p=0.02).
  • Bowel-Specific Royal London Hospital QOL Questionnaire: all median subscores of this bowel-specific questionnaire improve (lifestyle, coping and behavior, depression and self-perception, and embarrassment). See the table below.
  • Adverse events in the Hetzer study include infection, seroma, and loss of effect. Eight patients (22% or 8 out of 37 implanted patients) experienced complications that required surgical intervention. (A successful restimulation was possible for five of these patients.) Adverse effects of SNM were remedied in five patients by reprogramming the stimulator.

Complications reported in patients with long-term stimulation included infection/seroma, pain/sleeping disturbance, and loss of effect/dislocation.

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InterStim X™ is a recharge-free sacral neurostimulator system that delivers therapy to restore bowel and bladder control.

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