Actively Recruiting
Pelvic Health Electrically Evoked Recording (PEER) 2 Study
Led by MedtronicNeuro · Updated on 2026-03-03
300
Participants Needed
7
Research Sites
256 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
To collect physiological signals at several timepoints during the therapy evaluation period.
CONDITIONS
Official Title
Pelvic Health Electrically Evoked Recording (PEER) 2 Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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
- Willing to maintain current regimen (dosage and frequency) of any OAB, NOUR, or FI medication from baseline diary through the end of therapy evaluation
- For overactive bladder with urinary urge incontinence, diagnosis confirmed by at least 3 urge incontinence episodes with urgency in first 72 hours of voiding diary
- For overactive bladder with urinary frequency, diagnosis confirmed by 8 or more urgency frequency episodes per day in first 72 hours of voiding diary
- For non-obstructive urinary retention, diagnosis with elevated postvoid residual persisting at least 6 months documented on two or more occasions
- For fecal incontinence, diagnosis confirmed by at least 1 incontinent episode of more than staining in a 3-day bowel diary
You will not qualify if you...
- Currently enrolled or planning to enroll in an interventional clinical study that could confound results without pre-approval
- Implanted with a neurostimulator, pacemaker, or defibrillator
- Pelvic floor muscle dysfunction due to surgery or injury
- Neurological conditions such as multiple sclerosis, significant peripheral neuropathy, or spinal cord injury
- History of diabetes unless well-controlled by diet or medication
- Symptomatic urinary tract infection
- Primary stress incontinence or mixed incontinence where stress component dominates
- Recent botulinum toxin treatment within 9 months or plans for it during study
- Tibial neuromodulation therapy in last 3 months
- Planned MRI or therapeutic diathermy during therapy evaluation
- Women who are pregnant or planning pregnancy
- Current urinary tract mechanical obstruction such as benign prostatic enlargement or urethral stricture
- Uncorrected high grade internal rectal prolapse (fecal incontinence group only)
- Poor understanding of the study or poor compliance potential
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 7 locations
1
Indiana University Health Methodist Research Institute
Indianapolis, Indiana, United States, 46202
Actively Recruiting
2
LSUHSC Department of Urology
New Orleans, Louisiana, United States, 70112
Withdrawn
3
Ochsner Clinic Foundation
New Orleans, Louisiana, United States, 70121
Actively Recruiting
4
Mayo Clinic Urology/Urogynecology Department
Rochester, Minnesota, United States, 55905
Actively Recruiting
5
University Hospitals Cleveland Medical Center
Cleveland, Ohio, United States, 44106
Actively Recruiting
6
OhioHealth Physician's Group Urology
Hilliard, Ohio, United States, 43026-2050
Actively Recruiting
7
DHR Health Institute for Research and Development
Edinburg, Texas, United States, 78539
Completed
Research Team
K
Katherine Peterson
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
DEVICE_FEASIBILITY
Number of Arms
1
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