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

January 9, 2024 updated by: MedtronicNeuro
To collect physiological signals at several timepoints during the therapy evaluation period.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Recruiting
        • Indiana University Health Methodist Research Institute
        • Contact:
        • Contact:
        • Principal Investigator:
          • Charles Powell
    • Louisiana
      • New Orleans, Louisiana, United States, 70121
      • New Orleans, Louisiana, United States, 70112
        • Withdrawn
        • LSUHSC Department of Urology
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Recruiting
        • Mayo Clinic Urology/Urogynecology Department
        • Contact:
        • Principal Investigator:
          • Brian Linder
    • Ohio
      • Cleveland, Ohio, United States, 44106
        • Recruiting
        • University Hospitals Cleveland Medical Center
        • Contact:
        • Principal Investigator:
          • David Sheyn
        • Sub-Investigator:
          • Adonis Hijaz
        • Sub-Investigator:
          • Joseph Henderson
        • Sub-Investigator:
          • Anne Sammarco
        • Sub-Investigator:
          • Daisy Hassani
      • Hilliard, Ohio, United States, 43026-2050
    • Texas
      • Edinburg, Texas, United States, 78539
        • Recruiting
        • DHR Health Institute for Research and Development
        • Contact:
        • Contact:
        • Principal Investigator:
          • Henry Ruiz
        • Sub-Investigator:
          • Gustavo Villegas
        • Sub-Investigator:
          • Adrienne Casciato

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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 as demonstrated by a urinary voiding diary with a minimum of 5 clean intermittent self-catheterizations in a 7-day period; and chronic 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 a bowel diary as greater than or equal to 2 incontinent episodes of more than staining (i.e., either slight, moderate, or severe soiling) per week

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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
Time Frame: 1 day to 7 months
The proportion of subjects with evaluable signals will be summarized at each timepoint
1 day to 7 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

MedtronicNeuro

Investigators

  • Study Director: Nichole Carlson, Medtronic Pelvic Health

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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)

January 11, 2024

Last Update Submitted That Met QC Criteria

January 9, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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