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
This trial does not accept healthy volunteersQualifiers
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
Design model
Single group
Treatments tested in this trial
Sacral Neuromodulation
DeviceSacral neuromodulation delivers electrical stimulation to a sacral nerve
Treatment groups
300 Participants
are divided into 1 treatment groupGroup A: Pelvic health Electrically Evoked Recording (PEER) 2 StudyExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Number of subjects with physiological signals collected at each timepoint
The proportion of subjects with evaluable signals will be summarized at each timepoint
Time frame
1 day to 7 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov