The InterStim™ systems offer relief from overactive  bladder

The InterStim™ systems are the only sacral neuromodulation (SNM) product with five-year clinical data demonstrating sustained, long-term efficacy and quality of life improvements for patients suffering from overactive bladder (OAB).1,2

82% of subjects with OAB achieved therapeutic success at 5 years.†,‡

Highlights

  • Three times greater improvement in quality of life than what is considered clinically meaningful§,1,3
  • 45% of urinary incontinence subjects achieved complete continence at five years◊,1

Safety

There were no unanticipated adverse device effects. The most common AEs were: undesirable change in stimulation (22%, 60/272); implant site pain (15%, 40/272); and therapeutic product ineffective (13%, 36/272).

SNM results sustained at five years1

Percent responder rate
  • 100 —
    80 —
    60 —
    40 —
    20 —
    0 —
  • 80%
    Month 6  
    (n=240)
  • 85%
    Month 12
    (n=220)
  • 84%
    Month 24
    (n=203)
  • 83%
    Month 36
    (n=193)
  • 86%
    Month 48
    (n=183)
  • 82%
    Month 60
    (n=150)

Five-year overactive bladder study shows sustained efficacy3

The following are data from an additional post-approval, five-year, non-randomized, multicenter study showing sustained efficacy of sacral neuromodulation delivered by the InterStim™ systems for patients with urge incontinence, urgency-frequency, and non-obstructive urinary retention.

This study demonstrates long-term efficacy 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.

Urge incontinence‡,2

  • 59% of urge incontinent patients achieved ≥50% reduction in leaks/day
  • 71% of patients had ≥50% reduction in heavy leaks per day

Urge incontinence2

5-year clinical efficacy

◼ Intent-to-treat patient      ◼ Evaluable patients

Patients (%)
  • 80 —
    60 —
    40 —
    20 —
    0 —
  • 37%
    (n=36)
    ≥ 50% reduction in leaks/day
  • 59%
    (n=36)
  • 42%
    (n=35)
    ≥ 50% reduction in heavy leaks/day
  • 71%
    (n=35)



Evaluable patients — the subset of subjects for whom both baseline and five-year data were available
Intent-to-treat patients — all implanted subjects, including those who dropped out and were imputed as no change from baseline

Urgency/frequency symptoms‡,2

  • 56% of urgency-frequency patients achieved ≥50% increase in volume voided/void¶,2
  • 56% of patients reported an increase in voided volume with the same or reduced degree of urgency.¶,2

Urgency frequency2

5-year clinical efficacy

◼ Intent-to-treat patient      ◼ Evaluable patients

Patients (%)
  • 80 —
    60 —
    40 —
    20 —
    0 —
  • 28%
    (n=7)
    ≥ 50% reduction in voids/day
  • 39%
    (n=7)
  • 40%
    (n=10)
    ≥ 50% increase in volume voided/void
  • 56%
    (n=10)
  • 40%
    (n=10)
    improved degree of urgency prior to void
  • 56%
    (n=10)





Evaluable patients — the subset of subjects for whom both baseline and five-year data were available
Intent-to-treat patients — all implanted subjects, including those who dropped out and were imputed as no change from baseline

Safety

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.

See the InterStim™ systems

The InterStim™ systems may offer your patients relief from bladder and bowel symptoms.

Meet InterStim™ systems