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Pelvic Health Electrically Evoked Recording (PEER) 2 Study

RecruitingNAAges 18 Years - anyAllMedtronicNeuro
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In plain words

What the trial is, and whether it could suit you

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

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
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. H
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What it tests

  • Sacral Neuromodulation
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Where

7 sites
Indiana University Health Methodist Research Institute
Indianapolis, United States
LSUHSC Department of Urology
New Orleans, United States
Ochsner Clinic Foundation
New Orleans, United States
Mayo Clinic Urology/Urogynecology Department
Rochester, United States
University Hospitals Cleveland Medical Center
Cleveland, United States
OhioHealth Physician's Group Urology
Hilliard, United States
DHR Health Institute for Research and Development
Edinburg, United States
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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