The InterStim™ systems are demonstrated to be superior to standard medical therapy.1

Sacral neuromodulation (SNM) delivered by the InterStim™ system outperforms medications,† as shown in a six-month randomized study comparing SNM to standard medical therapy (SMT) in patients with symptoms with OAB.1

Evidence shows superior efficacy‡ for overactive bladder (OAB) symptoms.


Numbers reflect as treated results, defined as subjects with diary data at baseline and six 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. The most common device-related AEs were undesirable change in stimulation, implant site pain, and implant site infection.

◼ SNM◼ SMT

OAB responders (%)
  • 80 —
    60 —
    40 —
    20 —
    0 —
  • 76%
    (N = 51)
  • 49%
    (N = 73)
A responder was defined as greater to or equal than 50% improvement in average leaks or voids per day or a return to normal voiding (fewer than eight voids per day)

Quality of life improvements for OAB patients

3 times greater quality of life improvement than what is considered clinically significant compared to medications§

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 (AE) were reported. The most common device-related AEs were undesirable change in stimulation, implant site pain, and implant site infection.

◼ SNM◼ SMT
 

Mean improvement from baseline to month six
  • 60 —
    45 —
    30 —
    15 —
    0 —
  • 47
    n=51
  • 16
    n=77
  • 45
    n=51
  • 14
    n=77
  • 37
    n=51
  • 11
    n=77
  • 27
    n=51
  • 9
    n=76
  • 40
    n=51
  • 13
    n=76
ConcernCopingSleepSocial HRQLTotal

QOL was measured using the ICIQ-OABqol questionnaire

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