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

C
Charles Powell, MD

Primary Investigator

Overview

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

Description

This clinical trial information was submitted voluntarily under the applicable law and,herefore, certain submission deadlines may not apply. (That is, clinical trial informationhis 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 by2(j)(2) and (3) of the Public Health Service Act or 42 CFR 11.24 and 11.44.)

Eligibility

You may be eligible for this study if you meet the following criteria:

  • Conditions:
    Overactive Bladder, Fecal Incontinence, Urinary Retention
  • Age: 18 Years
  • Gender: All

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*quiring 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,d visits, and comply with the study protocol
  5. Willing to maintain current regimen (dosage and frequency) of any OAB medication frombaseline diary through the end of therapy evaluation
  6. For subjects with urinary urge incontinence, have a diagnosis of OAB as demonstratedvoiding diary by having a minimum of 3 episodes of urinary urge incontinence inhe first 72 hours (Episodes must have a mild, moderate, or severe degree of urgencyhis criterion) of the voiding diary.
  7. For subjects with urinary frequency, have a diagnosis of OAB as demonstrated on avoiding diary with greater than or equal to 8 urgency frequency episodes per daywithin the first 72 hours of the voiding diary.
        Note*: Candidate for or undergoing a Medtronic InterStim lead implant for labeleddication means that a clinical decision has already been made between a physician and theundergo Medtronic Interstim lead implant to treat the subject's condition. Thisdecision is to be made prior to discussing with the patient whether to enroll in the study.bstructive Urinary Retention Inclusion Criteria1. 18 years of age or older2. Candidate for or undergoing Medtronic InterStim lead implant for labeled indication*quiring an advanced evaluation3. Willing and able to provide signed and dated informed consent. Willing and able to independently and accurately complete diaries, questionnaires,d visits, and comply with the study protocol5. Willing to maintain current regimen (dosage and frequency) of any NOUR medication frombaseline diary through the end of therapy evaluation6. Have a diagnosis of non-obstructive urinary retention as demonstrated by a urinaryvoiding diary with a minimum of 5 clean intermittent self-catheterizations in a 7-dayd; and chronic non-obstructive urinary retention with an elevated postvoiddual (PVR) that has persisted for at least six months and is documented on two or.*: Candidate for or undergoing a Medtronic InterStim lead implant for labeleddication means that a clinical decision has already been made between a physician and theundergo Medtronic Interstim lead implant to treat the subject's condition. Thisdecision is to be made prior to discussing with the patient whether to enroll in the study.Fecal Incontinence Inclusion Criteria1. 18 years of age or older2. Candidate for or undergoing Medtronic InterStim lead implant labeled indication*quiring an advanced evaluation3. Willing and able to provide signed and dated informed consent. Willing and able to independently and accurately complete diaries, questionnaires,d visits, and comply with the study protocol5. Willing to maintain current regimen (dosage and frequency) of any FI medication frombaseline diary through the end of therapy evaluation6. Have a diagnosis of fecal incontinence as demonstrated by a bowel diary as greaterhan or equal to 2 incontinent episodes of more than staining (i.e., either slight,derate, or severe soiling) per week*: Candidate for or undergoing a Medtronic InterStim lead implant for labeleddication means that a clinical decision has already been made between a physician and theundergo Medtronic Interstim lead implant to treat the subject's condition. Thisdecision is to be made prior to discussing with the patient whether to enroll in the study.usion Criteria:veractive Bladder Criteria Exclusion Criteria1. Currently enrolled or planning to enroll in an interventional clinical study thatuld potentially confound the study results (co-enrollment in an interventional studyy allowed when documented pre-approval is obtained from the Medtronic studyger or designee)2. Implanted with a neurostimulator, pacemaker or defibrillator3. Pelvic floor muscle dysfunction due to surgical intervention or injury. Have neurological conditions such as multiple sclerosis, clinically significantheral neuropathy or spinal cord injury (e.g., paraplegia)5. History of diabetes unless the diabetes is well-controlled through diet and/ordications6. Have symptomatic urinary tract infection (UTI)7. Have primary stress incontinence or mixed incontinence where the stress componentverrides the urge component8. Treatment of voiding behavior with botulinum toxin in the past 9 months or any plan tohave botulinum toxin treatment during the study9. Treatment of symptoms with tibial neuromodulation therapy in the last 3 months10. Have knowledge of planned magnetic resonance imaging (MRIs) during the therapyvaluation portion of the study11. Have knowledge of planned shortwave diathermy, microwave diathermy, or therapeuticdiathermy12. Women who are pregnant or planning to become pregnant13. Current urinary tract mechanical obstruction (e.g. benign prostatic enlargement orurethral stricture)14. Characteristics indicating a poor understanding of the study or characteristics thatdicate the subject may have poor compliance with the study protocol requirementsbstructive Urinary Retention Exclusion Criteria1. Currently enrolled or planning to enroll in an interventional clinical study thatuld potentially confound the study results (co-enrollment in an interventional studyy allowed when documented pre-approval is obtained from the Medtronic studyger or designee)2. Implanted with a neurostimulator, pacemaker or defibrillator3. Pelvic floor muscle dysfunction due to surgical intervention or injury. Have neurological conditions such as multiple sclerosis, clinically significantheral neuropathy or spinal cord injury (e.g., paraplegia)5. History of diabetes unless the diabetes is well-controlled through diet and/ordications6. Have symptomatic urinary tract infection (UTI)7. Treatment of symptoms with tibial neuromodulation therapy in the last 3 months8. Have knowledge of planned magnetic resonance imaging (MRIs) during the therapyvaluation portion of the study9. Have knowledge of planned shortwave diathermy, microwave diathermy, or therapeuticdiathermy10. Women who are pregnant or planning to become pregnant11. Current urinary tract mechanical obstruction (e.g. benign prostatic enlargement orurethral stricture)12. Characteristics indicating a poor understanding of the study or characteristics thatdicate the subject may have poor compliance with the study protocol requirementsFecal Incontinence Exclusion Criteria1. Currently enrolled or planning to enroll in an interventional clinical study thatuld potentially confound the study results (co-enrollment in an interventional studyy allowed when documented pre-approval is obtained from the Medtronic studyger or designee)2. Implanted with a neurostimulator, pacemaker or defibrillator3. Pelvic floor muscle dysfunction due to surgical intervention or injury. Have neurological conditions such as multiple sclerosis, clinically significantheral neuropathy or spinal cord injury (e.g., paraplegia)5. Have uncorrected high grade internal rectal prolapse6. Treatment of symptoms with tibial neuromodulation therapy in the last 3 months7. Have knowledge of planned magnetic resonance imaging (MRIs) during the therapyvaluation portion of the study8. Have knowledge of planned shortwave diathermy, microwave diathermy, or therapeuticdiathermy9. Women who are pregnant or planning to become pregnant10. Characteristics indicating a poor understanding of the study or characteristics thatdicate the subject may have poor compliance with the study protocol requirements

Updated on 03 May 2024. Study ID: MDT20063
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