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New treatment option for Overactive Bladder
Official title Pelvic Health Electrically Evoked Recording (PEER) 2 Study
ClinicalTrials.gov ID: NCT05200923
What this study is testing
- What it's testing
- To collect physiological signals at several timepoints during the therapy evaluation period.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Overactive Bladder Criteria 1. 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
You likely can't join if
- Overactive Bladder Criteria Exclusion Criteria
- Currently enrolled or planning to enroll in an treatment clinical study that could potentially confound the study results (co-enrollment in an...
- 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
See the full eligibility criteria
Who can join
- Overactive Bladder Criteria 1. 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 people 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...
- For people 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 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...
- 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...
What rules you out
- Overactive Bladder Criteria Exclusion Criteria
- Currently enrolled or planning to enroll in an treatment clinical study that could potentially confound the study results (co-enrollment in an treatment study is only allowed when documented pre-approval is obtained...
- 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
- 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 treatment clinical study that could potentially confound the study results (co-enrollment in an treatment study is only allowed when documented pre-approval is obtained...
- 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 treatment clinical study that could potentially confound the study results (co-enrollment in an treatment study is only allowed when documented pre-approval is obtained...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Indianapolis, Indiana, United States
- New Orleans, Louisiana, United States
- Rochester, Minnesota, United States
- Cleveland, Ohio, United States
- Hilliard, Ohio, United States
- Edinburg, Texas, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Indianapolis, Indiana, United States; New Orleans, Louisiana, United States; Rochester, Minnesota, United States; Cleveland, Ohio, United States; Hilliard, Ohio, United States; Edinburg, Texas, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.