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

Sponsor
MedtronicNeuro (Industry)
Overall Status
Recruiting
CT.gov ID
NCT05200923
Collaborator
(none)
300
Enrollment
6
Locations
1
Arm
59
Anticipated Duration (Months)
50
Patients Per Site
0.8
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Device: Sacral Neuromodulation
 N/A

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

Study Type:
Interventional
Anticipated 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 :
Jan 18, 2022
Anticipated Primary Completion Date :
Dec 18, 2026
Anticipated Study Completion Date :
Dec 18, 2026

Arms and Interventions

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

Primary Outcome Measures

  1. Number of subjects with physiological signals collected at each timepoint [1 day to 7 months]

    The proportion of subjects with evaluable signals will be summarized at each timepoint

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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 72 hours (Episodes must have a mild, moderate, or severe degree of urgency to meet this criterion)

  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

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

Locations

Site City State Country Postal Code
1 Indiana University Health Methodist Research Institute Indianapolis Indiana United States 46202
2 LSUHSC Department of Urology New Orleans Louisiana United States 70112
3 Ochsner Clinic Foundation New Orleans Louisiana United States 70121
4 Mayo Clinic Urology/Urogynecology Department Rochester Minnesota United States 55905
5 OhioHealth Physician's Group Urology Hilliard Ohio United States 43026-2050
6 DHR Health Institute for Research and Development Edinburg Texas United States 78539

Sponsors and Collaborators

  • MedtronicNeuro

Investigators

  • Study Director: Nichole Carlson, Medtronic Pelvic Health

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
MedtronicNeuro
ClinicalTrials.gov Identifier:
NCT05200923
Other Study ID Numbers:
  • MDT20063
First Posted:
Jan 21, 2022
Last Update Posted:
Aug 23, 2022
Last Verified:
Aug 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
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
Additional relevant MeSH terms:
Fecal Incontinence
Urinary Bladder, Overactive
Urinary Retention

Study Results

No Results Posted as of Aug 23, 2022