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Neuromodulation Device
Sacral Neuromodulation for Overactive Bladder (PEER 2 Trial)
N/A
Recruiting
Research Sponsored by MedtronicNeuro
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Candidate for or undergoing Medtronic InterStim lead implant for labeled indication requiring an advanced evaluation
For subjects with urinary frequency, have a diagnosis of OAB as demonstrated on a voiding diary
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 day to 7 months
Awards & highlights
PEER 2 Trial Summary
This trial will collect signals from the body at different times to see how effective the therapy is.
Who is the study for?
This trial is for adults with overactive bladder who can complete diaries, attend visits, and follow the study protocol. They must be candidates for or already receiving Medtronic InterStim lead implant therapy. Exclusions include stress incontinence dominance, urinary tract obstruction, enrollment in other studies that could affect results, recent tibial neuromodulation therapy, planned MRIs during the study period, pregnancy or planning to become pregnant, poor compliance likelihoods, certain neurological conditions like multiple sclerosis or spinal cord injury.Check my eligibility
What is being tested?
The PEER 2 Study is testing sacral neuromodulation by collecting physiological signals at different times during the therapy evaluation period. It aims to understand how this treatment affects patients with bowel incontinence and overactive bladder symptoms.See study design
What are the potential side effects?
While specific side effects are not listed here for sacral neuromodulation used in treating overactive bladder and bowel incontinence issues; generally such interventions may cause discomfort at the implant site, changes in bowel or bladder function and potential nerve-related side effects.
PEER 2 Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am a candidate for or am getting a Medtronic InterStim device.
Select...
I have been diagnosed with overactive bladder based on my voiding diary.
PEER 2 Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1 day to 7 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 day to 7 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Number of subjects with physiological signals collected at each timepoint
PEER 2 Trial Design
1Treatment groups
Experimental Treatment
Group I: Pelvic health Electrically Evoked Recording (PEER) 2 StudyExperimental Treatment1 Intervention
Collect physiological signals
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Sacral Neuromodulation
2018
N/A
~90
Find a Location
Who is running the clinical trial?
MedtronicNeuroLead Sponsor
69 Previous Clinical Trials
20,519 Total Patients Enrolled
Nichole CarlsonStudy DirectorMedtronic Pelvic Health
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have a blockage in my urinary tract.My overactive bladder is due to surgery or injury.I am aware of my upcoming diathermy treatment for overactive bladder.I have been treated for overactive bladder with tibial neuromodulation in the last 3 months.My diabetes is well-managed with diet or medication.My main bladder issue is stress incontinence, more than urge incontinence.I have been diagnosed with overactive bladder based on a voiding diary.I am pregnant or planning to become pregnant and have an overactive bladder.I am a candidate for or am getting a Medtronic InterStim device.I have been diagnosed with overactive bladder based on my voiding diary.I have not used botulinum toxin for overactive bladder in the last 9 months and have no plans to use it during the study.I agree to keep taking my current bladder medication as prescribed until the end of the study.I am 18 years old or older.I have a neurological condition like MS, significant nerve damage, or spinal cord injury.I have symptoms of a urinary tract infection.You have a medical device like a pacemaker or neurostimulator implanted in your body.
Research Study Groups:
This trial has the following groups:- Group 1: Pelvic health Electrically Evoked Recording (PEER) 2 Study
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is enrollment for this trial currently open?
"Affirmative. Clinicaltrials.gov outlines that this research endeavour, which was launched on January 18th 2022, is actively seeking out participants. Approximately 300 patients need to be enrolled across 6 different medical facilities."
Answered by AI
How many geographic sites have been identified to host this research project?
"Presently, this research endeavour is running at 6 sites: Hilliard, New Orleans and Edinburg among others. To minimise the burden of travel associated with participation in this trial, it is advised that participants select the location closest to them."
Answered by AI
To what extent is this experiment being conducted with participants?
"Absolutely, the info on clinicaltrials.gov demonstrates that this trial has been actively enrolling participants since its launch on 18th January 2022 and was most recently updated on 22nd August of the same year. 300 patients are currently being sought from 6 different medical centres for participation in the study."
Answered by AI
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