Overactive BladderPEER 2NCT05200923
Pelvic Health Electrically Evoked Recording (PEER) 2 Study
A study testing Sacral Neuromodulation in people with Overactive Bladder and Fecal Incontinence, run by MedtronicNeuro at 7 sites in United States.
Trial summary
To collect physiological signals at several timepoints during the therapy evaluation period. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Overactive Bladder, Fecal Incontinence, Urinary Retention
- What is being tested?
- Sacral Neuromodulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 7 sitesUnited States
- Study dates
- 18 Jan 2022to 18 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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 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 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.
Who cannot join
- 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
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- 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
Trial locations and contacts
7 sites in 1 country. Contact the study team or a site near you to ask about taking part.
7 sites in 1 country
United States7 sites, 5 recruiting
- Recruiting
University Hospitals Cleveland Medical Center
Cleveland, Ohio, 44106
Paul Cinicola, 216-286-7376, paul.cinicola@uhhospitals.org
David Sheyn
- Completed
DHR Health Institute for Research and Development
Edinburg, Texas, 78539
- Recruiting
OhioHealth Physician's Group Urology
Hilliard, Ohio, 43026-2050
Diamond Rapp, 740-375-2490, Diamond.Rapp@ohiohealth.com
Ketul Shah
- Recruiting
Indiana University Health Methodist Research Institute
Indianapolis, Indiana, 46202
Andi Nowakowski, 317-278-6752, amnowako@iu.edu
Charles Powell
- Withdrawn
LSUHSC Department of Urology
New Orleans, Louisiana, 70112
- Recruiting
Ochsner Clinic Foundation
New Orleans, Louisiana, 70121
Samantha Ahrens, 504-842-2455, samantha.ahrens@ochsner.org
Colin Goudelocke
- Recruiting
Mayo Clinic Urology/Urogynecology Department
Rochester, Minnesota, 55905
Stacy Wroblewski, 507-422-3984, wroblewski.stacy@mayo.edu
Brian Linder
About this study
To collect physiological signals at several timepoints during the therapy evaluation period.
Read the detailed description
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.)
- Conditions
- Overactive Bladder, Fecal Incontinence, Urinary Retention
- Being tested
- Sacral Neuromodulation
- Medical subject headings
- Urinary Bladder, Overactive, Fecal Incontinence, Urinary Retention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sacral NeuromodulationDevice
Sacral neuromodulation delivers electrical stimulation to a sacral nerve
| Study group | Role | What they receive |
|---|---|---|
| Pelvic health Electrically Evoked Recording (PEER) 2 Study | Experimental | Collect physiological signals Receives: Device: Sacral Neuromodulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of subjects with physiological signals collected at each timepoint
The proportion of subjects with evaluable signals will be summarized at each timepoint
Measured: 1 day to 7 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2022
- Study start18 Jan 2022
- Primary completion18 Dec 2026 (estimated)
- Study completion18 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Overactive BladderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- MedtronicNeuro
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Katherine Peterson, Study director, Medtronic Pelvic Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05200923
- Sponsor's protocol ID
- MDT20063
- Acronym
- PEER 2
- Status last verified
- Oct 2026
- First submitted
- 20 Dec 2021
- Last updated
- 13 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Goudelocke C, Ruiz H, Powell CR, Sheyn D, Linder BJ, Shah K, Villegas G, Henderson J, Sammarco AG, Offutt SJ, Keller DUJ, Bittner KC, Bink H, Merlo I, Slopsema JP, Nikolas LJ. Sensing in Sacral Neuromodulation: Objective, Individualized Stimulation Response Thresholds Directly From the Lead. Neurourol Urodyn. 2026 Sep 25. doi: 10.1002/nau.70443. Online ahead of print.
PubMed 42788388
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pelvic Health Electrically Evoked Recording (PEER) 2 Study
- ClinicalTrials.gov ID
- NCT05200923
- Acronym / sponsor ID
- PEER 2 / MDT20063
- Conditions
- Overactive Bladder, Fecal Incontinence, Urinary Retention
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- MedtronicNeuroIndustry (pharma, biotech, devices)
- Study start
- 18 Jan 2022 (actual)
- Primary completion
- 18 Dec 2026 (estimated)
- Study completion
- 18 Dec 2026 (estimated)
- First posted
- 21 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To collect physiological signals at several timepoints during the therapy evaluation period.
Detailed description
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.)
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pelvic health Electrically Evoked Recording (PEER) 2 Study | Experimental | Device: Sacral NeuromodulationCollect physiological signals |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (25 listed)
- 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
Key exclusion criteria (39 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sacral NeuromodulationSacral neuromodulation delivers electrical stimulation to a sacral nerve | Device | Pelvic health Electrically Evoked Recording (PEER) 2 Study |
Primary outcome
Number of subjects with physiological signals collected at each timepoint
Time frame: 1 day to 7 months
The proportion of subjects with evaluable signals will be summarized at each timepoint
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2026.
- Derived from this study: PubMed 42788388Goudelocke C, Ruiz H, Powell CR, Sheyn D, Linder BJ, Shah K, Villegas G, Henderson J, Sammarco AG, Offutt SJ, Keller DUJ, Bittner KC, Bink H, Merlo I, Slopsema JP, Nikolas LJ. Sensing in Sacral Neuromodulation: Objective, Individualized Stimulation Response Thresholds Directly From the Lead. Neurourol Urodyn. 2026 Sep 25. doi: 10.1002/nau.70443. Online ahead of print.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Katherine Peterson study director
Medtronic Pelvic Health
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sacral Neuromodulation in people with Overactive Bladder and Fecal Incontinence, run by MedtronicNeuro at 7 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 25 inclusion and 39 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Katherine Peterson (414-704-4065, katherine.r.peterson@medtronic.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of subjects with physiological signals collected at each timepoint (time frame: 1 day to 7 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05200923, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Oct 2026.