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

Study on Sacral Nerve Stimulation and Signal Recording

C
Charles Powell, MD

Primary Investigator

Enrolling By Invitation
18 years or above
All
Phase N/A
300 participants needed
3 Locations

Brief description of study

The purpose of this study is to collect recordings of signals resulting from stimulation of a sacral nerve (stimulation evoked signals) using prototype investigational systems. Signals will be collected using various stimulation paradigms at several time points after lead implant during the therapy evaluation period. Signals will also be collected as the subject completes activities of daily living to understand factors that contribute to signal features.  Learnings from this study may be used to inform future engineering efforts to support development of sensing-based hardware and possible algorithm development.

THIS STUDY IS ENROLLING BY INVITATION ONLY

Detailed description of study

The primary functions of the investigational research systems are to (1) deliver electrical stimulation to the sacral nerve through commercial SNM leads and (2) sense, record, and store resulting evoked signals from the SNM leads. There are two investigational research systems (PEER and Argus 1 PEER) which will be used to collect evoked signals resulting from stimulation of a sacral nerve over time. 

Enrolled subjects will participate in a study cohort, defined as a group of subjects who share the same study visit cadence, research system(s), and data collection. There will be multiple cohorts in this study. The investigational system will be used only in subjects with a percutaneous extension (e.g. during the therapy evaluation period).
After removal of the percutaneous extension (for neurostimulator implant or lead removal), use of any investigational systems will cease and subjects will follow the commercially approved labeling for the InterStim System and the Investigator’s standard of care. Observational data (e.g. symptom diary data, questionnaires, adverse
events, or device deficiencies) may be collected after neurostimulator implant.

The study is expected to last up to 5 years and each subject’s participation is expected to last approximately 1 day to 7 months from enrollment, determined by the specific details of their assigned cohort. Subjects’ participation in each cohort will not exceed a total of 5 scheduled visits: Informed consent/baseline; lead implant/signal acquisition; mid-therapy evaluation signal acquisition visit; follow-up signal acquisition visit; and post-neurostimulator implant visit. The post-neurostimulator implant visit may occur in person or via mail. Subject’s participation involving the investigational system(s) will end at their follow-up signal acquisition visit, which will be no longer than the currently approved duration based on the current SNM device labeling.

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
  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 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
 

                            


                        
                    

                    
                    

            
    

    

        
This study investigates the collection of signals from the sacral nerve when it is stimulated. The sacral nerve is a part of the nervous system that can affect bladder and bowel function. The study uses special systems to collect signals from this nerve to better understand how the nerve works during different activities.
Participants will have small devices placed temporarily to record signals from the nerve. The devices will record signals while participants do everyday tasks. This helps researchers learn more about the signals and how they change. The study also looks at how these signals can be used in the future to develop new technology.
  • Who can participate: Adults aged 18 and older with overactive bladder, non-obstructive urinary retention, or fecal incontinence may participate. Candidates must be undergoing or planning to undergo a Medtronic InterStim lead implant and be willing to follow study procedures.
  • Study details: Participants will have a device temporarily placed to record nerve signals during daily activities.
  • Study timelines and visits: The study will last up to 5 years. The study requires 5 visits.

    


     

        Updated on
        
        08 Jan 2026.
        
        
            Study ID:   UROL-MEDTRONIC-PEER-2, MDT20063, 14919  
        
    


        
        
        

                
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Interested in the study?


This study is accepting only persons who receive care at a certain clinic or doctor or who are part of an invited group. Questions about this study can be directed to the study team listed in the description or contact your doctor to see if you are eligible.


Accepting Referrals by Invitation Only