Actively Recruiting
Pelvic Health Electrically Evoked Recording (PEER) 2 Study
Led by MedtronicNeuro · Updated on 2026-03-03
300
Participants Needed
7
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the collection of physiological signals at multiple timepoints during the therapy evaluation period in individuals with overactive bladder, fecal incontinence, or urinary retention. This interventional study involves patients who are candidates for or undergoing Medtronic InterStim lead implant therapy for these conditions. The purpose is to monitor and record physiological responses related to sacral neuromodulation treatment, a device that delivers electrical stimulation to a sacral nerve. The study focuses on the use of sacral neuromodulation as the investigational device. Participants will undergo therapy evaluation involving the Medtronic InterStim lead implant, during which physiological signals will be collected from one day up to seven months. This evaluation period is designed to observe the effects and gather data while participants maintain their current medication regimens for their conditions. The study does not involve masking or blinding and includes only one study arm centered on this device-based therapy. Participants will provide informed consent and complete diaries, questionnaires, and study visits as part of the protocol. Researchers will collect physiological signals at several timepoints during the evaluation period and monitor adherence to medication and study procedures. The primary outcome is the number of subjects with physiological signals collected at each timepoint from one day to seven months. The total study duration and follow-up align with this time frame. Safety assessments and compliance monitoring are integral parts of the participant involvement.
CONDITIONS
Brief 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 medication for overactive bladder, fecal incontinence, or non-obstructive urinary retention throughout the study
- For overactive bladder with urinary urge incontinence, diagnosis demonstrated by at least 3 episodes of urinary urge incontinence with urgency in the first 72 hours of voiding diary
- For overactive bladder with urinary frequency, diagnosis demonstrated by 8 or more urgency frequency episodes per day in the first 72 hours of voiding diary
- For non-obstructive urinary retention, diagnosis with elevated postvoid residual for at least six months documented on two or more occasions
- For fecal incontinence, diagnosis demonstrated by at least 1 incontinent episode beyond staining in a 3-day bowel diary
You will not qualify if you...
- Currently enrolled or planning to enroll in another interventional clinical study without documented pre-approval
- Implanted with a neurostimulator, pacemaker, or defibrillator
- Pelvic floor muscle dysfunction due to surgical intervention or injury
- Neurological conditions such as multiple sclerosis, clinically significant peripheral neuropathy, or spinal cord injury (e.g., paraplegia)
- History of diabetes unless well-controlled with diet or medication
- Symptomatic urinary tract infection
- Primary stress incontinence or mixed incontinence where stress overrides urge (for overactive bladder)
- Recent botulinum toxin treatment within 9 months or planned during study (for overactive bladder)
- Recent tibial neuromodulation therapy within 3 months or planned during study (for all conditions)
- Planned magnetic resonance imaging during therapy evaluation
- Planned shortwave, microwave, or therapeutic diathermy
- Women who are pregnant or planning to become pregnant
- Current urinary tract mechanical obstruction (e.g., benign prostatic enlargement or urethral stricture)
- Poor understanding of the study or likely poor compliance with protocol
- Uncorrected high grade internal rectal prolapse (for fecal incontinence)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 7 months
Participants undergo sacral neuromodulation device implantation to deliver electrical stimulation to a sacral nerve as part of the study.
Multiple visits for device evaluation and physiological signal collection
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
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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