Pelvic Health Electrically Evoked Recording (PEER) 2 Study (PEER 2)
C
Charles Powell, MD
Primary Investigator
Administratively Closed
18 years or above
All
Phase
N/A
300 participants needed
3 Locations
Brief description of study
To collect physiological signals at several timepoints during the therapy evaluation period.
Detailed description of study
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 of study
You may be eligible for this study if you meet the following criteria:
- Conditions: Overactive Bladder, Fecal Incontinence, Urinary Retention
-
Age: 18 years or above
-
Gender: All
Inclusion Criteria:
Overactive Bladder Criteria Inclusion Criteria
- 18 years of age or older
- Candidate for or undergoing Medtronic InterStim lead implant for labeled indication*quiring an advanced evaluation
- 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 protocol
- Willing to maintain current regimen (dosage and frequency) of any OAB medication frombaseline diary through the end of therapy evaluation
- 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.
- 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 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
Updated on
30 Apr 2025.
Study ID: UROL-MEDTRONIC-PEER-2, MDT20063, 14919
