Pelvic Health Electrically Evoked Recording (PEER) 2 Study

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

Detailed Description
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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.)

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

Conditions
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Overactive Bladder, Fecal Incontinence, Urinary Retention

Intervention / Treatment
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* Device: Sacral Neuromodulation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Overactive Bladder Criteria Inclusion Criteria 18 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. Non-Obstructive Urinary Retention Inclusion Criteria 18 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 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 18 years of age or older Candidate for or undergoing Medtronic InterStim lead implant 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 FI medication from baseline diary through the end of therapy evaluation 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 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 Non-Obstructive Urinary Retention Exclusion Criteria 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) 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 Fecal Incontinence Exclusion Criteria 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) Have uncorrected high grade internal rectal prolapse 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 Characteristics indicating a poor understanding of the study or characteristics that indicate the subject may have poor compliance with the study protocol requirements

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Device Feasibility
Intervention 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<br>Collect physiological signals | Device: Sacral Neuromodulation<br>* Sacral neuromodulation delivers electrical stimulation to a sacral nerve<br>|

What is the study measuring?
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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 |