Pelvic Health Electrically Evoked Recording (PEER) 2 Study
MedtronicNeuro
Summary
To collect physiological signals at several timepoints during the therapy evaluation period.
Description
This clinical trial information was submitted voluntarily under the applicable law and, therefore, certain submission deadlines may not apply. (That is, clinical trial information for this non-applicable clinical trial was submitted under section 402(j)(4)(A) of the Public Health Service Act and 42 CFR 11.60 and is not subject to the deadlines established by sections 402(j)(2) and (3) of the Public Health Service Act or 42 CFR 11.24 and 11.44.)
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: Overactive Bladder Criteria Inclusion Criteria 1. 18 years of age or older 2. Candidate for or undergoing Medtronic InterStim lead implant for labeled indication\* requiring an advanced evaluation 3. Willing and able to provide signed and dated informed consent 4. Willing and able to independently and accurately complete diaries, questionnaires, attend visits, and comply with the study protocol 5. Willing to maintain current regimen (dosage and frequency) of any OAB medication from baseline diary through the end of therapy evaluation 6. For subjects with urinary urge inco…
Interventions
- DeviceSacral Neuromodulation
Sacral neuromodulation delivers electrical stimulation to a sacral nerve
Locations (7)
- Indiana University Health Methodist Research InstituteIndianapolis, Indiana
- LSUHSC Department of UrologyNew Orleans, Louisiana
- Ochsner Clinic FoundationNew Orleans, Louisiana
- Mayo Clinic Urology/Urogynecology DepartmentRochester, Minnesota
- University Hospitals Cleveland Medical CenterCleveland, Ohio
- OhioHealth Physician's Group UrologyHilliard, Ohio