RecruitingNot Applicable

Pelvic Health Electrically Evoked Recording (PEER) 2 Study

United States300 participantsStarted 2022-01-18

Plain-language summary

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

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. 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
✓. 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.
✓. 18 years of age or older

✕. 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)
✕. 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

Number of subjects with physiological signals collected at each timepoint

Timeframe: 1 day to 7 months

NCT IDNCT05200923

SponsorMedtronicNeuro

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-12-18

Katherine Peterson

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. 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
✓. 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.
✓. 18 years of age or older

✕. 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)
✕. 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