Pelvic Health Electrically Evoked Recording (PEER) 2 Study
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorMedtronicNeuro
About this trial
To collect physiological signals at several timepoints during the therapy evaluation period.
Eligibility criteria
Qualifiers
18 years of age or older
Candidate for or undergoing Medtronic InterStim lead implant for labeled indication* requiring an advanced evaluation
Willing and able to provide signed and dated informed consent
Willing and able to independently and accurately complete diaries, questionnaires, attend visits, and comply with the study protocol
Disqualifiers
Currently enrolled or planning to enroll in an interventional clinical study that could potentially confound the study results (co-enrollment in an interventional study is only allowed when documented pre-approval is obtained from the Medtronic study manager or designee)
Implanted with a neurostimulator, pacemaker or defibrillator
Pelvic floor muscle dysfunction due to surgical intervention or injury
Have neurological conditions such as multiple sclerosis, clinically significant peripheral neuropathy or spinal cord injury (e.g., paraplegia)
Trial design
Treatments tested in this trial
- Sacral Neuromodulation
Treatment groups
300 Participants
are divided into 1 treatment groupLocations
7Indiana University Health Methodist Research Institute46202, IndianapolisIndiana, United States
LSUHSC Department of Urology70112, New OrleansLouisiana, United States
Ochsner Clinic Foundation70121, New OrleansLouisiana, United States
Mayo Clinic Urology/Urogynecology Department55905, RochesterMinnesota, United States
Sponsors and collaborators
MedtronicNeuro
Lead sponsor
Source ClinicalTrials.gov