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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05200923
Recruitment Status : Recruiting
First Posted : January 21, 2022
Last Update Posted : January 11, 2024
Sponsor:
Information provided by (Responsible Party):
MedtronicNeuro

Study Description
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Brief Summary:
To collect physiological signals at several timepoints during the therapy evaluation period.

Condition or disease Intervention/treatment Phase
Overactive Bladder Fecal Incontinence Urinary Retention Device: Sacral Neuromodulation Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Device Feasibility
Official Title: Pelvic Health Electrically Evoked Recording (PEER) 2 Study
Actual Study Start Date : January 18, 2022
Estimated Primary Completion Date : December 18, 2026
Estimated Study Completion Date : December 18, 2026
Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. 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


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05200923


Contacts
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Contact: Nichole Carlson 7635262757 nichole.carlson@medtronic.com
Contact: Anne Miller 7635263583 anne.e.miller@medtronic.com

Locations
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United States, Indiana
Indiana University Health Methodist Research Institute Recruiting
Indianapolis, Indiana, United States, 46202
Contact: Charles Powell    317-944-4622    crpowell@iupui.edu   
Contact: Courtney Dhondt    (317) 274-1791    cgerler@iu.edu   
Principal Investigator: Charles Powell         
United States, Louisiana
LSUHSC Department of Urology Withdrawn
New Orleans, Louisiana, United States, 70112
Ochsner Clinic Foundation Recruiting
New Orleans, Louisiana, United States, 70121
Contact: Neeti Galwankar    504-842-9971    neeti.galwankar@ochsner.org   
Contact: Rachel Graham       rgraham@ochsner.org   
Principal Investigator: Colin Goudelocke         
United States, Minnesota
Mayo Clinic Urology/Urogynecology Department Recruiting
Rochester, Minnesota, United States, 55905
Contact: David Burnette    507-422-9146    David.burnette@mayo.edu   
Principal Investigator: Brian Linder         
United States, Ohio
University Hospitals Cleveland Medical Center Recruiting
Cleveland, Ohio, United States, 44106
Contact: Steven Madias    216-844-1447    steven.madias@uhhospitals.org   
Principal Investigator: David Sheyn         
Sub-Investigator: Adonis Hijaz         
Sub-Investigator: Joseph Henderson         
Sub-Investigator: Anne Sammarco         
Sub-Investigator: Daisy Hassani         
OhioHealth Physician's Group Urology Recruiting
Hilliard, Ohio, United States, 43026-2050
Contact: Ketul Shah    614-544-1460    ketul.shah@ohiohealth.com   
Contact: Kevin Miller    (614) 788-3886    kevin.miller@ohiohealth.com   
Principal Investigator: Ketul Shah         
United States, Texas
DHR Health Institute for Research and Development Recruiting
Edinburg, Texas, United States, 78539
Contact: Henry Ruiz    956-362-8767    henryeruiz@gmail.com   
Contact: Kayllie Lomeli    (956) 362-2393    k.lomeli@dhr-rgv.com   
Principal Investigator: Henry Ruiz         
Sub-Investigator: Gustavo Villegas         
Sub-Investigator: Adrienne Casciato         
Sponsors and Collaborators
MedtronicNeuro
Investigators
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Study Director: Nichole Carlson Medtronic Pelvic Health
More Information
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Responsible Party: MedtronicNeuro
ClinicalTrials.gov Identifier: NCT05200923    
Other Study ID Numbers: MDT20063
First Posted: January 21, 2022    Key Record Dates
Last Update Posted: January 11, 2024
Last Verified: January 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Fecal Incontinence
Urinary Bladder, Overactive
Urinary Retention
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
Rectal Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Urination Disorders