Pelvic Health Electrically Evoked Recording (PEER) 2 Study (PEER 2)

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

Study Overview

• Status: Recruiting
• Conditions: Overactive Bladder; Urinary Retention; Fecal Incontinence
• Intervention / Treatment: Device: Sacral Neuromodulation

Detailed Description

This clinical trial information was submitted voluntarily under the applicable law and, therefore, certain submission deadlines may not apply. (That is, clinical trial information for this non-applicable clinical trial was submitted under section 402(j)(4)(A) of the Public Health Service Act and 42 CFR 11.60 and is not subject to the deadlines established by sections 402(j)(2) and (3) of the Public Health Service Act or 42 CFR 11.24 and 11.44.)

• Study Type: Interventional
• Enrollment (Estimated): 300
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Katherine Peterson; Phone Number: 414-704-4065; Email: katherine.r.peterson@medtronic.com

Study Locations

• United States
  • Indiana
    • Indianapolis, Indiana, United States, 46202
      • Recruiting
      • Indiana University Health Methodist Research Institute
      • Principal Investigator: Charles Powell
      • Contact: Andi Nowakowski; Phone Number: 317-278-6752; Email: amnowako@iu.edu
  • Louisiana
    • New Orleans, Louisiana, United States, 70121
      • Recruiting
      • Ochsner Clinic Foundation
      • Principal Investigator: Colin Goudelocke
      • Contact: Samantha Ahrens; Phone Number: 504-842-2455; Email: samantha.ahrens@ochsner.org
    • New Orleans, Louisiana, United States, 70112
      • Withdrawn
      • LSUHSC Department of Urology
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Recruiting
      • Mayo Clinic Urology/Urogynecology Department
      • Principal Investigator: Brian Linder
      • Contact: Stacy Wroblewski; Phone Number: 507-422-3984; Email: wroblewski.stacy@mayo.edu
  • Ohio
    • Cleveland, Ohio, United States, 44106
      • Recruiting
      • University Hospitals Cleveland Medical Center
      • Principal Investigator: David Sheyn
      • Sub-Investigator: Adonis Hijaz
      • Sub-Investigator: Joseph Henderson
      • Sub-Investigator: Anne Sammarco
      • Contact: Hachem Ziadeh; Phone Number: 440-470-8830; Email: Hachem.ziadeh@uhhospitals.org
    • Hilliard, Ohio, United States, 43026-2050
      • Recruiting
      • OhioHealth Physician's Group Urology
      • Principal Investigator: Ketul Shah
      • Contact: Diamond Rapp; Phone Number: 740-375-2490; Email: Diamond.Rapp@ohiohealth.com
  • Texas
    • Edinburg, Texas, United States, 78539
      • Completed
      • DHR Health Institute for Research and Development

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

Overactive Bladder Criteria Inclusion Criteria

1. 18 years of age or older
2. Candidate for or undergoing Medtronic InterStim lead implant for labeled indication* requiring an advanced evaluation
3. Willing and able to provide signed and dated informed consent
4. Willing and able to independently and accurately complete diaries, questionnaires, attend visits, and comply with the study protocol
5. Willing to maintain current regimen (dosage and frequency) of any OAB medication from baseline diary through the end of therapy evaluation
6. 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.
7. 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.

Non-Obstructive Urinary Retention Inclusion Criteria

1. 18 years of age or older
2. Candidate for or undergoing Medtronic InterStim lead implant for labeled indication* requiring an advanced evaluation
3. Willing and able to provide signed and dated informed consent
4. Willing and able to independently and accurately complete diaries, questionnaires, attend visits, and comply with the study protocol
5. Willing to maintain current regimen (dosage and frequency) of any NOUR medication from baseline diary through the end of therapy evaluation
6. 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.

Fecal Incontinence Inclusion Criteria

1. 18 years of age or older
2. Candidate for or undergoing Medtronic InterStim lead implant labeled indication* requiring an advanced evaluation
3. Willing and able to provide signed and dated informed consent
4. Willing and able to independently and accurately complete diaries, questionnaires, attend visits, and comply with the study protocol
5. Willing to maintain current regimen (dosage and frequency) of any FI medication from baseline diary through the end of therapy evaluation
6. Have a diagnosis of fecal incontinence as demonstrated by 3-day a bowel diary as greater than or equal to 1 incontinent episode of more than staining (i.e., either slight, moderate, or severe soiling)

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.

Exclusion Criteria:

Overactive Bladder Criteria Exclusion Criteria

1. 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)
2. Implanted with a neurostimulator, pacemaker or defibrillator
3. Pelvic floor muscle dysfunction due to surgical intervention or injury
4. Have neurological conditions such as multiple sclerosis, clinically significant peripheral neuropathy or spinal cord injury (e.g., paraplegia)
5. History of diabetes unless the diabetes is well-controlled through diet and/or medications
6. Have symptomatic urinary tract infection (UTI)
7. Have primary stress incontinence or mixed incontinence where the stress component overrides the urge component
8. Treatment of voiding behavior with botulinum toxin in the past 9 months or any plan to have botulinum toxin treatment during the study
9. Treatment of symptoms with tibial neuromodulation therapy in the last 3 months
10. Have knowledge of planned magnetic resonance imaging (MRIs) during the therapy evaluation portion of the study
11. Have knowledge of planned shortwave diathermy, microwave diathermy, or therapeutic diathermy
12. Women who are pregnant or planning to become pregnant
13. Current urinary tract mechanical obstruction (e.g. benign prostatic enlargement or urethral stricture)
14. Characteristics indicating a poor understanding of the study or characteristics that indicate the subject may have poor compliance with the study protocol requirements

Non-Obstructive Urinary Retention Exclusion Criteria

1. 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)
2. Implanted with a neurostimulator, pacemaker or defibrillator
3. Pelvic floor muscle dysfunction due to surgical intervention or injury
4. Have neurological conditions such as multiple sclerosis, clinically significant peripheral neuropathy or spinal cord injury (e.g., paraplegia)
5. History of diabetes unless the diabetes is well-controlled through diet and/or medications
6. Have symptomatic urinary tract infection (UTI)
7. Treatment of symptoms with tibial neuromodulation therapy in the last 3 months
8. Have knowledge of planned magnetic resonance imaging (MRIs) during the therapy evaluation portion of the study
9. Have knowledge of planned shortwave diathermy, microwave diathermy, or therapeutic diathermy
10. Women who are pregnant or planning to become pregnant
11. Current urinary tract mechanical obstruction (e.g. benign prostatic enlargement or urethral stricture)
12. Characteristics indicating a poor understanding of the study or characteristics that indicate the subject may have poor compliance with the study protocol requirements

Fecal Incontinence Exclusion Criteria

1. 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)
2. Implanted with a neurostimulator, pacemaker or defibrillator
3. Pelvic floor muscle dysfunction due to surgical intervention or injury
4. Have neurological conditions such as multiple sclerosis, clinically significant peripheral neuropathy or spinal cord injury (e.g., paraplegia)
5. Have uncorrected high grade internal rectal prolapse
6. Treatment of symptoms with tibial neuromodulation therapy in the last 3 months
7. Have knowledge of planned magnetic resonance imaging (MRIs) during the therapy evaluation portion of the study
8. Have knowledge of planned shortwave diathermy, microwave diathermy, or therapeutic diathermy
9. Women who are pregnant or planning to become pregnant
10. Characteristics indicating a poor understanding of the study or characteristics that indicate the subject may have poor compliance with the study protocol requirements

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Device Feasibility
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Pelvic health Electrically Evoked Recording (PEER) 2 Study; Collect physiological signals	Device: Sacral Neuromodulation; Sacral neuromodulation delivers electrical stimulation to a sacral nerve

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: MedtronicNeuro
• Investigators: Study Director: Katherine Peterson, Medtronic Pelvic Health

Study record dates

Study Major Dates

• Study Start (Actual): January 18, 2022
• Primary Completion (Estimated): December 18, 2026
• Study Completion (Estimated): December 18, 2026

Study Registration Dates

• First Submitted: December 20, 2021
• First Submitted That Met QC Criteria: January 7, 2022
• First Posted (Actual): January 21, 2022

Study Record Updates

• Last Update Posted (Actual): March 3, 2026
• Last Update Submitted That Met QC Criteria: March 2, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Male Urogenital Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Intestinal Diseases; Urination Disorders; Lower Urinary Tract Symptoms; Urological Manifestations; Digestive System Diseases; Gastrointestinal Diseases; Rectal Diseases; Urinary Bladder Diseases; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Urinary Bladder, Overactive; Urinary Retention; Fecal Incontinence
• Other Study ID Numbers: MDT20063

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No