PEER 2: Pelvic nerve recording during Medtronic InterStim sacral neuromodulation

Pelvic Health Electrically Evoked Recording (PEER) 2 Study

This tests whether recording electrical signals from pelvic nerves during Medtronic InterStim sacral neuromodulation can help guide therapy for adults with overactive bladder, fecal incontinence, or urinary retention.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 300 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: MedtronicNeuro (Industry-sponsored)
• Locations: 7 sites (Indianapolis, Indiana and 6 other locations)
• Trial ID: NCT05200923 on ClinicalTrials.gov

What this trial studies

The trial collects electrically evoked pelvic nerve signals at several timepoints during the therapy evaluation period around sacral neuromodulation lead placement. Adults who are candidates for or undergoing Medtronic InterStim lead implantation will have recordings taken alongside standard clinical evaluation and will complete symptom diaries and questionnaires. Data from multiple U.S. sites will be analyzed to identify signal patterns that correlate with clinical response during the evaluation phase. Participants are asked to maintain baseline medication regimens and attend scheduled study visits for signal capture and follow-up.

Who should consider this trial

Good fit: Adults (18+) who are candidates for or undergoing Medtronic InterStim lead implantation for overactive bladder, urinary urgency/frequency, fecal incontinence, or urinary retention and who can complete diaries, questionnaires, and study visits.

Not a fit: Patients who are not receiving a Medtronic InterStim lead, cannot comply with diaries or follow-up visits, or who have conditions outside the inclusion criteria are unlikely to receive benefit from this protocol.

Why it matters

Potential benefit: If successful, this approach could help clinicians predict which patients will benefit from sacral neuromodulation and speed therapy optimization to reduce ineffective implants.

How similar studies have performed: Sacral neuromodulation is an established treatment, and small research studies have explored electrically evoked pelvic nerve signals, but using these recordings to guide therapy remains experimental.

Eligibility criteria

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. 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

Where this trial is running

Indianapolis, Indiana and 6 other locations

• Indiana University Health Methodist Research Institute — Indianapolis, Indiana, United States (Recruiting)
• LSUHSC Department of Urology — New Orleans, Louisiana, United States (Withdrawn)
• Ochsner Clinic Foundation — New Orleans, Louisiana, United States (Recruiting)
• Mayo Clinic Urology/Urogynecology Department — Rochester, Minnesota, United States (Recruiting)
• University Hospitals Cleveland Medical Center — Cleveland, Ohio, United States (Recruiting)
• OhioHealth Physician's Group Urology — Hilliard, Ohio, United States (Recruiting)
• DHR Health Institute for Research and Development — Edinburg, Texas, United States (Completed)

Study contacts

• Study coordinator: Katherine Peterson

Conditions Overactive Bladder; Fecal Incontinence; Urinary Retention