Pelvic Health Electrically Evoked Recording (PEER) 2 Study

NCT05200923 | Recruiting FDA Device

• 1 other identifier: MDT20063
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 7

Brief Summary

To collect physiological signals at several timepoints during the therapy evaluation period.

Conditions

Overactive Bladder; Fecal Incontinence; Urinary Retention

Outcome Measures

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

  1 day to 7 months

Study Arms (1)

Pelvic health Electrically Evoked Recording (PEER) 2 Study

EXPERIMENTAL

Collect physiological signals

Device: Sacral Neuromodulation

Interventions

Sacral Neuromodulation DEVICE

Sacral neuromodulation delivers electrical stimulation to a sacral nerve

Pelvic health Electrically Evoked Recording (PEER) 2 Study

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 medication from baseline diary through the end of therapy evaluation
• For subjects with urinary urge incontinence, have a diagnosis of OAB as demonstrated on a voiding diary by having a minimum of 3 episodes of urinary urge incontinence in the first 72 hours (Episodes must have a mild, moderate, or severe degree of urgency to meet this criterion) of the voiding diary.
• For subjects with urinary frequency, have a diagnosis of OAB as demonstrated on a voiding diary with greater than or equal to 8 urgency frequency episodes per day within the first 72 hours of the voiding diary.
• Note\*: Candidate for or undergoing a Medtronic InterStim lead implant for labeled indication means that a clinical decision has already been made between a physician and the patient to undergo Medtronic Interstim lead implant to treat the subject's condition. This decision is to be made prior to discussing with the patient whether to enroll in the study.
• 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 NOUR medication from baseline diary through the end of therapy evaluation
• Have a diagnosis of non-obstructive urinary retention with an elevated postvoid residual (PVR) that has persisted for at least six months and is documented on two or more separate occasions.
• Note\*: Candidate for or undergoing a Medtronic InterStim lead implant for labeled indication means that a clinical decision has already been made between a physician and the patient to undergo Medtronic Interstim lead implant to treat the subject's condition. This decision is to be made prior to discussing with the patient whether to enroll in the study.

You may not qualify if:

• 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)
• History of diabetes unless the diabetes is well-controlled through diet and/or medications
• Have symptomatic urinary tract infection (UTI)
• Have primary stress incontinence or mixed incontinence where the stress component overrides the urge component
• Treatment of voiding behavior with botulinum toxin in the past 9 months or any plan to have botulinum toxin treatment during the study
• Treatment of symptoms with tibial neuromodulation therapy in the last 3 months
• Have knowledge of planned magnetic resonance imaging (MRIs) during the therapy evaluation portion of the study
• Have knowledge of planned shortwave diathermy, microwave diathermy, 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)
• Characteristics indicating a poor understanding of the study or characteristics that indicate the subject may have poor compliance with the study protocol requirements
• 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)

Sponsors & Collaborators

• MedtronicNeuro: lead

Study Sites (7)

Indiana University Health Methodist Research Institute

Indianapolis, Indiana, 46202, United States

RECRUITING

LSUHSC Department of Urology

New Orleans, Louisiana, 70112, United States

WITHDRAWN

Ochsner Clinic Foundation

New Orleans, Louisiana, 70121, United States

RECRUITING

Mayo Clinic Urology/Urogynecology Department

Rochester, Minnesota, 55905, United States

RECRUITING

University Hospitals Cleveland Medical Center

Cleveland, Ohio, 44106, United States

RECRUITING

OhioHealth Physician's Group Urology

Hilliard, Ohio, 43026-2050, United States

RECRUITING

DHR Health Institute for Research and Development

Edinburg, Texas, 78539, United States

COMPLETED

MeSH Terms

Conditions

Urinary Bladder, Overactive; Fecal Incontinence; Urinary Retention

Condition Hierarchy (Ancestors)

Urinary Bladder Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Rectal Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Urination Disorders

Study Officials

• Katherine Peterson

  Medtronic Pelvic Health

  STUDY DIRECTOR

Central Study Contacts

Katherine Peterson

CONTACT

414-704-4065; katherine.r.peterson@medtronic.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 20, 2021
• First Posted: January 21, 2022
• Study Start: January 18, 2022
• Primary Completion (Estimated): December 18, 2026
• Study Completion (Estimated): December 18, 2026
• Last Updated: March 3, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (7)