PATIENT SELECTION Sacral neuromodulation

CANDIDATES

Sacral Neuromodulation, delivered by the Interstim™ system, is indicated for patients who have failed or could not tolerate more conservative treatments for one or more of the following conditions:

  • Overactive bladder (OAB)
    • Urge incontinence
    • Urgency-frequency
  • Non-obstructive urinary retention (UR)
  • Chronic fecal incontinence

Both men and women are affected by these conditions.

BLADDER CONTROL CANDIDATES

A broad range of patients with overactive bladder and non-obstructive urinary retention are considered suitable for Sacral Neuromodulation once they have failed or could not tolerate more conservative treatments.

Sacral Neuromodulation is most appropriate for patients who:

  • Suffer from quality of life issues
  • Experience urge incontinence or urgency-frequency
  • Experience urinary retention without an obstruction
  • Desire an alternative to medication due to side-effects or lack of efficacy
  • Desire an alternative to injectables

Sacral Neuromodulation is not appropriate for patients who:

  • Have not demonstrated an appropriate response to the evaluation (screening test)
  • Experience primarily stress incontinence
  • Are unable to operate the neuromodulation system
  • Are not appropriate candidates for surgery
  • Experience urinary retention due to mechanical obstructions such as benign prostatic hypertrophy, cancer, or urethral stricture

Safety and effectiveness of the InterStim system have not been established for:

  • Bilateral stimulation
  • Pregnancy, unborn fetus, and delivery
  • Pediatric use under the age of 16
  • Patients with neurological disease origins

BOWEL CONTROL CANDIDATES

A broad range of chronic fecal incontinent patients are considered suitable for Sacral Neuromodulation, delivered by the InterStim system, if they have failed or are not candidates for more conservative treatments such as medication, behavior modifications, bowel retraining, and/or pelvic muscle training.

Sacral Neuromodulation is most appropriate for patients who:

  • Suffer from quality of life issues
  • Experience chronic fecal incontinence

Sacral Neuromodulation is not appropriate for patients who:

  • Have not demonstrated an appropriate response to the evaluation
  • Are unable to operate the neuromodulation system
  • Are not appropriate candidates for surgery

Safety and effectiveness of the InterStim system have not been established for:

  • Bilateral stimulation
  • Pregnancy, unborn fetus, and delivery
  • Pediatric use under the age of 18
  • Patients with progressive, systemic neurologic diseases