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Neuromodulation Device
Wearable Bladder Neuromodulation Device for Overactive Bladder (REDUCEOAB Trial)
N/A
Waitlist Available
Research Sponsored by Avation Medical, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Willing and capable of giving informed consent
Female Subjects of child-bearing potential must have a negative urine dip stick pregnancy test at baseline
Timeline
Screening 3 weeks
Treatment Varies
Follow Up length of study, on average 24 months
Awards & highlights
REDUCEOAB Trial Summary
This trial is testing a new, self-adjusting device to treat OAB (overactive bladder) compared to a sham device. The study will see if the new device is safe and effective.
Who is the study for?
Adults diagnosed with Overactive Bladder (OAB) for at least 3 months, experiencing frequent urination or incontinence. Participants must be stable on current medications affecting OAB and not pregnant. Excluded are those with neurogenic bladder causes, failed third-line treatments within 2 years, stress-predominant mixed urinary incontinence, polyuria, pacemaker/defibrillator users, other clinical study participants during this trial's term.Check my eligibility
What is being tested?
The trial is testing a new wearable device called the Avation System that doesn't require surgery against a Sham System to see if it helps adults with OAB. It's a controlled study where some people will get the real treatment and others won't but won't know which one they're getting.See study design
What are the potential side effects?
Potential side effects aren't specified here but could include skin irritation from the wearable device or abnormal sensations due to neuromodulation therapy.
REDUCEOAB Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am willing and able to agree to participate in the study.
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I am a woman who can have children and my pregnancy test is negative.
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I have had overactive bladder symptoms for at least 3 months.
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My medication doses for OAB have been stable for at least 4 weeks.
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I am 18 years old or older.
REDUCEOAB Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ length of study, on average 24 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~length of study, on average 24 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
The proportion of Subjects with a successful response
Secondary outcome measures
Quality of Life Endpoints: Questionnaires
Other outcome measures
Open-Label Phase Endpoints
REDUCEOAB Trial Design
2Treatment groups
Active Control
Placebo Group
Group I: Experimental ArmActive Control1 Intervention
Avation System
Group II: Control ArmPlacebo Group1 Intervention
Sham Avation System
Find a Location
Who is running the clinical trial?
Avation Medical, Inc.Lead Sponsor
1 Previous Clinical Trials
5,000 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am willing and able to agree to participate in the study.You have a scar, metal implant, or large tattoo that could affect the treatment.You go to the bathroom 11 times or more and/or have 3 or more accidents in a day, based on a 3-day record of your bathroom habits.I am a woman who can have children and my pregnancy test is negative.I have no surgery planned that would limit my movement or require a long hospital stay in the next 12 weeks.I have had overactive bladder symptoms for at least 3 months.My medication doses for OAB have been stable for at least 4 weeks.I urinate more than 2.5 liters a day.I have used TENS in the past year or plan to use it in the next 12 weeks.I have a bladder condition like interstitial cystitis or similar issues.You have a skin condition like a rash, open wounds, or allergic reaction where the Therapy Garment will be put.I experience unusual feelings in my lower leg, like numbness or pain from touch.I have symptoms or a diagnosis of prostate issues.I mainly have stress urinary incontinence or am being treated for it.I had PTNS treatment for overactive bladder within the last 6 months.I am 18 years old or older.I haven't used any experimental drugs or devices in the last 3 months.You have a device implanted to treat overactive bladder or incontinence.My last OAB treatment didn’t work within the last 2 years.I have incontinence because of a neurological condition.You have had a serious problem with using drugs or alcohol in the past 6 months that was not treated.I have had 3 or more UTIs in the months before joining.I have received Botox for my overactive bladder in the last 8 months.I have trouble fully emptying my bladder.
Research Study Groups:
This trial has the following groups:- Group 1: Experimental Arm
- Group 2: Control Arm
Awards:
This trial has 0 awards, including: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.
What is the upper limit of participants engaged in this experiment?
"Affirmative. Details found on clinicaltrials.gov corroborate that this medical trial, first published in April 2022, is actively seeking volunteers. The research team needs to recruit 150 people from a single health centre."
Answered by AI
Are there still openings for study participants?
"Affirmative. Clinicaltrials.gov details that this medical trial is currently looking for volunteers, with the first listing going up on April 14th 2022 and being updated most recently on May 16th 2022. 150 patients need to be recruited from 1 location."
Answered by AI
Who else is applying?
What site did they apply to?
Ochsner Medical Center
What portion of applicants met pre-screening criteria?
Met criteria
Why did patients apply to this trial?
I'm willing to try most anything to help my issues, it seems the older I get the more issues I have. I also like helping advance medical science.
PatientReceived 2+ prior treatments
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