Overactive BladderREDUCEOABNCT05381116
A Sham-Controlled Study to Evaluate the Safety and Efficacy of a Smart, Self-Adjusting, Surgery-Free, Wearable Bladder Neuromodulation System for Overactive Bladder
A study testing Avation System in people with Overactive Bladder and Urinary Urge Incontinence, run by Avation Medical, Inc. at 6 sites in United States.
Trial summary
This is a prospective, multi-center, sham-controlled study comparing the safety and effectiveness of the self-adjusting, surgery-free, wearable Active System to a Sham System on adult Subjects diagnosed with OAB. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Overactive Bladder, Urinary Urge Incontinence, Urge Incontinence
- What is being tested?
- Avation System
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 125 participants
- Where
- 6 sitesUnited States
- Study dates
- 14 Apr 2022to 1 Jul 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female and 18 years of age or older at the time of enrollment
- Willing and capable of giving informed consent
- Willing and able to comply with all Study-related requirements and procedures
- Have been diagnosed or have symptoms of OAB for at least 3 months prior to enrollment
- Have an average of 11 or more voiding events and/or 3 or more incontinent events per 24-hour period in a 3-Day Bladder Diary(a minimum of 30 voiding events over the 3 days measured by the Diary)
- If currently on medications that may affect their OAB symptoms, is on a stable dose (no new, discontinued, or change in dose) of all prescribed medications for at least 4 weeks prior to enrollment or throughout the Study
- Female Subjects of child-bearing potential must have a negative urine dip stick pregnancy test at baseline
Who cannot join
- Has been diagnosed with incontinence due to neurogenic bladder(stroke, CNS tumors, Parkinson's etc.)
- Have failed a third line treatment (PTNS, Botox or SNS) for their OAB because of lack of effectiveness within the 2 years prior to enrollment
- Have evidence of an uncontrolled active disruptive psychological or psychiatric disorder or other known condition significant enough to impact perception of pain, compliance of intervention and/or ability to evaluate treatment outcomes, in the opinion of the Investigator
- Has or had a significant untreated substance use disorder or polysubstance use disorder stemming from dependency-producing medications, alcohol, and/or illicit drugs less than 6 months prior to enrollment
- Are planning to or have scheduled a surgery, for any condition, that would require catheterization, or a prolonged hospital stay and affect the ability to ambulate, use the toilet, or complete Therapy during the first 12 weeks of the Study
- Has symptoms of, been diagnosed, or being actively treated for benign prostatic hyperplasia or prostate cancer (weak stream, straining, hesitancy, or intermittency)
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- Have a pacemaker or implanted defibrillator
- Has a neurological disorder that affects the bladder or a diagnosis of interstitial cystitis, radiation cystitis, or fistulas
- Incontinence due to stress-predominant mixed urinary incontinence (greater that 60% of the time)or being actively treated for stress urinary incontinence(Diagnosed or by review of the Baseline 3-Day Bladder Diary)
- Has been diagnosed with or has symptoms of polyuria (>2500 cc urine output per day)
- Has urinary retention or incomplete bladder emptying
- Have a documented current or reoccurring Urinary Tract Infection (3 or more in the months prior to enrollment)
- Have had Botox treatment for their OAB in the previous 8 months
- Have used TENS anywhere on the body within the last year for any reason or anticipated use of TENS within 12 weeks of enrollment in pelvic region, back or legs for any reason
- Had PTNS treatment for OAB within 6 months prior to enrollment.
- Use of investigational drug/device Therapy, for any reason, within past 12 weeks
- Current use or implantation of an implanted device for treatment of their OAB or incontinence (including but not limited to sacral nerve stimulators)
- Participation in another clinical Study during the term of the Study
- Pregnant or planning to become pregnant during the Study. Female Subjects of childbearing potential who become pregnant during the Study will be withdrawn from the Study and will be asked to sign a separate pregnancy consent form to allow the Investigator and Sponsor to follow up on the Subject's pregnancy and outcome
- Has scar tissue, metal, or another implant or a large tattoo that might interfere with Therapy
- Has a neurological disorder that causes abnormal sensations in the lower leg (loss of sensation or allodynia)
- Has a skin condition, for example allergic reaction, rash or open wounds, in the area of where the Therapy Garment will be placed
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
Ochsner Medical Center
New Orleans, Louisiana, 70121
Women's Health Institute
Oak Lawn, Illinois, 60453
Flourish Research
San Antonio, Texas, 78229
Regional Urology
Shreveport, Louisiana, 71106
Eclipse Clinical Research
Tucson, Arizona, 85745
Tranquil Medical Rsearch
Webster, Texas, 77598
About this study
Official title: A Prospective, Sham-Controlled, Safety and Efficacy Study of a Smart, Self-Adjusting, Surgery-Free, Wearable Bladder Modulation and Digital Health System With Objective Confirmation of Nerve Activation for Use in Home by Subjects With Overactive Bladder Syndrome
This is a prospective, multi-center, sham-controlled study comparing the safety and effectiveness of the self-adjusting, surgery-free, wearable Active System to a Sham System on adult Subjects diagnosed with OAB.
- Being tested
- Avation System, Sham Avation System
- Keywords
- Overactive Bladder, OAB, Urinary Incontinence, Neuromodulation, Bioelectronic Medicine, Urologic Disorders, Wearable, Digital Health, Closed-Loop, EMG, Sham, Continuous Sensing, Automatic Adjustment
- Medical subject headings
- Urinary Bladder, Overactive, Urinary Incontinence, Urge, Urinary Incontinence, Urologic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Avation SystemDevice
Subjects will perform therapy with active Avation System three (3) times a week for thirty (30) minutes each time over a 12-week period. At the end of the twelve (12) weeks of therapy, eligible Subjects from the Active Arm will be offered the opportunity to participate in the additional twenty one (21) month Open-Label Phase.
Sham Avation SystemDevice
Subjects will perform therapy with sham Avation System three (3) times a week for thirty (30) minutes each time over a 12-week period. At the end of the twelve (12) weeks of therapy, all Subjects from the Sham Arm will be offered the opportunity to crossover and participate in the additional twenty one (21) month Open-Label Phase.
| Study group | Role | What they receive |
|---|---|---|
| Experimental Arm | Active comparator | Avation System Receives: Device: Avation System |
| Control Arm | Sham comparator | Sham Avation System Receives: Device: Sham Avation System |
What is being measured
The primary outcome is the main question the study is designed to answer.
The proportion of Subjects with a successful response
The proportion of Subjects with a successful response, where success is defined as:
For enrolled Subjects that meet the inclusion criteria for average voids per day (frequency): a Subject that achieves a 50% or greater reduction, from baseline (Visit 1) to Week 12 (Visit 4), in average voids per day relative to an upper normal limit of an average of 8 voids per day, or
For enrolled Subjects that meet the inclusion criteria for incontinence events per day: a Subject that achieves a 50% or greater reduction from baseline (Visit 1) to Week 12 (Visit 4) in average incontinence events (IE) per day.
Measured: Blinded Lead-In Portion of Study,12 Weeks
Secondary outcomes (1)
Quality of Life Endpoints: Questionnaires
Evaluation of the Subject Quality of Life questionnaires used throughout the duration of the trial.
Measured: Length of Study, 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2022
- Study start14 Apr 2022
- Primary completion1 Jul 2023
- Study completion1 Jul 2023
Why it stopped: Sponsor Initiated
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Overactive BladderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 125 participants (actual)
Sponsor and investigators
- Lead sponsor
- Avation Medical, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05381116
- Sponsor's protocol ID
- AMHOAB2101
- Acronym
- REDUCEOAB
- Status last verified
- May 2024
- First submitted
- 3 May 2022
- Last updated
- 29 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Sham-Controlled, Safety and Efficacy Study of a Smart, Self-Adjusting, Surgery-Free, Wearable Bladder Modulation and Digital Health System With Objective Confirmation of Nerve Activation for Use in Home by Subjects With Overactive Bladder Syndrome
- ClinicalTrials.gov ID
- NCT05381116
- Acronym / sponsor ID
- REDUCEOAB / AMHOAB2101
- Keywords
- Overactive Bladder, OAB, Urinary Incontinence, Neuromodulation, Bioelectronic Medicine, Urologic Disorders, Wearable, Digital Health
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Sponsor Initiated
- Enrolment
- 125 participants (actual)
- Lead sponsor
- Avation Medical, Inc.Industry (pharma, biotech, devices)
- Study start
- 14 Apr 2022 (actual)
- Primary completion
- 1 Jul 2023 (actual)
- Study completion
- 1 Jul 2023 (actual)
- First posted
- 19 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a prospective, multi-center, sham-controlled study comparing the safety and effectiveness of the self-adjusting, surgery-free, wearable Active System to a Sham System on adult Subjects diagnosed with OAB.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental Arm | Active comparator | Device: Avation SystemAvation System |
| Control Arm | Sham comparator | Device: Sham Avation SystemSham Avation System |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Male or female and 18 years of age or older at the time of enrollment
- Willing and capable of giving informed consent
- Willing and able to comply with all Study-related requirements and procedures
- Have been diagnosed or have symptoms of OAB for at least 3 months prior to enrollment
- Have an average of 11 or more voiding events and/or 3 or more incontinent events per 24-hour period in a 3-Day Bladder Diary(a minimum of 30 voiding events over the 3 days measured by the Diary)
Key exclusion criteria (22 listed)
- Has been diagnosed with incontinence due to neurogenic bladder(stroke, CNS tumors, Parkinson's etc.)
- Have failed a third line treatment (PTNS, Botox or SNS) for their OAB because of lack of effectiveness within the 2 years prior to enrollment
- Have evidence of an uncontrolled active disruptive psychological or psychiatric disorder or other known condition significant enough to impact perception of pain, compliance of intervention and/or ability to evaluate treatment outcomes, in the opinion of the Investigator
- Has or had a significant untreated substance use disorder or polysubstance use disorder stemming from dependency-producing medications, alcohol, and/or illicit drugs less than 6 months prior to enrollment
- Are planning to or have scheduled a surgery, for any condition, that would require catheterization, or a prolonged hospital stay and affect the ability to ambulate, use the toilet, or complete Therapy during the first 12 weeks of the Study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Avation SystemSubjects will perform therapy with active Avation System three (3) times a week for thirty (30) minutes each time over a 12-week period. At the end of the twelve (12) weeks of therapy, eligible Subjects from the Active Arm will be offered the opportunity to participate in the additional twenty one (21) month Open-Label Phase. | Device | Experimental Arm |
| Sham Avation SystemSubjects will perform therapy with sham Avation System three (3) times a week for thirty (30) minutes each time over a 12-week period. At the end of the twelve (12) weeks of therapy, all Subjects from the Sham Arm will be offered the opportunity to crossover and participate in the additional twenty one (21) month Open-Label Phase. | Device | Control Arm |
Primary outcome
The proportion of Subjects with a successful response
Time frame: Blinded Lead-In Portion of Study,12 Weeks
The proportion of Subjects with a successful response, where success is defined as: For enrolled Subjects that meet the inclusion criteria for average voids per day (frequency): a Subject that achieves a 50% or greater reduction, from baseline (Visit 1) to Week 12 (Visit 4), in average voids per day relative to an upper normal limit of an average of 8 voids per day, or For enrolled Subjects that meet the inclusion criteria for incontinence events per day: a Subject that achieves a 50% or greater reduction from baseline (Visit 1) to Week 12 (Visit 4) in average incontinence events (IE) per day.
1 secondary outcome
Quality of Life Endpoints: Questionnaires
Time frame: Length of Study, 24 months
Results and safety
The study was stopped early (reason given: Sponsor Initiated). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Avation System in people with Overactive Bladder and Urinary Urge Incontinence, run by Avation Medical, Inc. at 6 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 29 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Sponsor Initiated). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The proportion of Subjects with a successful response (time frame: Blinded Lead-In Portion of Study,12 Weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 May 2024.