Last updated on June 2020

InterStim Basic Evaluation Lead Post-Market Clinical Follow-up Study

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions: Urinary Incontinence | bladder disorder | Urge Incontinence | Urgency-frequency Syndrome | Bladder Disorders | Overactive Bladder
  • Age: Between 18 - 100 Years
  • Gender: Male or Female

Inclusion Criteria:

  1. Subjects 18 years of age or older
  2. Candidate for sacral neuromodulation in accordance with the InterStim System labeling
  3. Have a diagnosis of overactive bladder (OAB) as demonstrated by either urinary urge incontinence and/or urinary frequency on a 3-day voiding diary
  4. Willing and able to accurately complete study diaries, questionnaire, attend visits, and comply with the study protocol
  5. Willing and able to provide signed and dated informed consent

Exclusion Criteria:

  1. Have neurological conditions such as multiple sclerosis, clinically significant peripheral neuropathy or spinal cord injury (e.g., paraplegia)
  2. Have implantable pacemakers, or defibrillators
  3. Have primary stress incontinence or mixed incontinence where the stress component overrides the urge component
  4. Have knowledge of planned MRIs, diathermy, microwave exposure, high output ultrasonic exposure, or radio frequency (RF) energy exposure not included within the scanning conditions provided with the InterStim System labeling
  5. Women who are pregnant or planning to become pregnant during participation in the study
  6. Characteristics indicating a poor understanding of the study or characteristics that indicate the subject may have poor compliance with the study protocol requirements
  7. Concurrent participation in another clinical study that may add additional safety risks and/or confound study results.

Recruitment Status: Open

Brief Description Eligibility Contact Research Team

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