Overactive Bladder Clinical Trial
— REDUCEOABOfficial 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
NCT number | NCT05381116 |
Other study ID # | AMHOAB2101 |
Secondary ID | |
Status | Terminated |
Phase | N/A |
First received | |
Last updated | |
Start date | April 14, 2022 |
Est. completion date | July 1, 2023 |
Verified date | May 2024 |
Source | Avation Medical, Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Terminated |
Enrollment | 125 |
Est. completion date | July 1, 2023 |
Est. primary completion date | July 1, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: 1. Male or female and 18 years of age or older at the time of enrollment 2. Willing and capable of giving informed consent 3. Willing and able to comply with all Study-related requirements and procedures 4. Have been diagnosed or have symptoms of OAB for at least 3 months prior to enrollment 5. 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) 6. 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 7. Female Subjects of child-bearing potential must have a negative urine dip stick pregnancy test at baseline Exclusion Criteria: 1. Has been diagnosed with incontinence due to neurogenic bladder(stroke, CNS tumors, Parkinson's etc.) 2. 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 3. 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 4. 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 5. 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 6. Has symptoms of, been diagnosed, or being actively treated for benign prostatic hyperplasia or prostate cancer (weak stream, straining, hesitancy, or intermittency) 7. Have a pacemaker or implanted defibrillator 8. Has a neurological disorder that affects the bladder or a diagnosis of interstitial cystitis, radiation cystitis, or fistulas 9. 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) 10. Has been diagnosed with or has symptoms of polyuria (>2500 cc urine output per day) 11. Has urinary retention or incomplete bladder emptying 12. Have a documented current or reoccurring Urinary Tract Infection (3 or more in the months prior to enrollment) 13. Have had Botox treatment for their OAB in the previous 8 months 14. 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 15. Had PTNS treatment for OAB within 6 months prior to enrollment. 16. Use of investigational drug/device Therapy, for any reason, within past 12 weeks 17. Current use or implantation of an implanted device for treatment of their OAB or incontinence (including but not limited to sacral nerve stimulators) 18. Participation in another clinical Study during the term of the Study 19. 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 20. Has scar tissue, metal, or another implant or a large tattoo that might interfere with Therapy 21. Has a neurological disorder that causes abnormal sensations in the lower leg (loss of sensation or allodynia) 22. Has a skin condition, for example allergic reaction, rash or open wounds, in the area of where the Therapy Garment will be placed |
Country | Name | City | State |
---|---|---|---|
United States | Ochsner Medical Center | New Orleans | Louisiana |
United States | Women's Health Institute | Oak Lawn | Illinois |
United States | Flourish Research | San Antonio | Texas |
United States | Regional Urology | Shreveport | Louisiana |
United States | Eclipse Clinical Research | Tucson | Arizona |
United States | Tranquil Medical Rsearch | Webster | Texas |
Lead Sponsor | Collaborator |
---|---|
Avation Medical, Inc. |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Open-Label Phase Endpoints | During the Open-Label Phase, efficacy endpoints 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) 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 in average incontinence events (IE) per day, except that Subjects initially enrolled in the Sham Arm will convert to Active Therapy (3x per week for 12 weeks followed by at least 1x per week for the remainder of the Study) and endpoints will be measured against their baseline (Visit 1) diary.
. |
Length of Study, 24 months | |
Primary | 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. |
Blinded Lead-In Portion of Study,12 Weeks | |
Secondary | Quality of Life Endpoints: Questionnaires | Evaluation of the Subject Quality of Life questionnaires used throughout the duration of the trial. | Length of Study, 24 months |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT04578899 -
"The Effectiveness of Transvertebral Magnetic Neuromodulation in Patients With Detrusor Overactivity"
|
N/A | |
Active, not recruiting |
NCT03556891 -
Pivotal Study of eCoin for Overactive Bladder With Urgency Urinary Incontinence
|
N/A | |
Not yet recruiting |
NCT05977634 -
Transcutaneous Tibial Nerve Stimulation for Idiopathic Overactive Bladder
|
N/A | |
Completed |
NCT01955408 -
Severity of Overactive Bladder Symptoms in Patients After Synergo Treatment
|
N/A | |
Recruiting |
NCT06201013 -
Efficacy and Safety of Vitamin D in the Treatment of OAB-wet in Children
|
N/A | |
Recruiting |
NCT03727711 -
TPTNS: Home vs Hospital Treatment for Overactive Bladder
|
N/A | |
Completed |
NCT00768521 -
A Study to Test the Effects of Tolterodine Tartrate in Patients With Overactive Bladder (0000-107)
|
Phase 1 | |
Completed |
NCT03625843 -
Mindfulness Exercises to Reduce Anxiety and Pain During Urodynamic Testing
|
N/A | |
Completed |
NCT02211846 -
A Study to Evaluate the Pharmacokinetics, Safety and Tolerability of Mirabegron OCAS (Oral Controlled Absorption System) in Pediatric Subjects With Neurogenic Detrusor Overactivity or Overactive Bladder
|
Phase 1 | |
Completed |
NCT02857816 -
PRospective Study to Evaluate EffectivenesS With the NURO™ PErcutaneous Tibial Neuromodulation System in Patients With OAB
|
N/A | |
Completed |
NCT02835846 -
Investigation of the Effect of the Female Urinary Microbiome on Incontinence
|
Phase 4 | |
Withdrawn |
NCT02320201 -
Foot Neuromodulation for Overactive Bladder in Children
|
N/A | |
Completed |
NCT02202031 -
Controlling Urgency Through Relaxation Exercises
|
N/A | |
Completed |
NCT01458197 -
A Phase 2 Study to Compare the Efficacy and Tolerability of Tarafenacin 0.2 mg and Tarafenacin 0.4 mg to Placebo in Patients Suffering From Overactive Bladder.
|
Phase 2 | |
Not yet recruiting |
NCT01409512 -
Evaluation of Autonomic System Before and After Anticholinergic Treatment in Women With Overactive Bladder
|
N/A | |
Completed |
NCT01437670 -
Observational Study to Estimate the Dry Mouth in OAB Patients With Solifenacin
|
N/A | |
Not yet recruiting |
NCT01423838 -
Comparison of Solifenacin and Oxybutynin in the Treatment of Overactive Bladder
|
Phase 4 | |
Terminated |
NCT01758848 -
Physical Therapy for Overactive Bladder
|
N/A | |
Withdrawn |
NCT01210859 -
Effects of Antimuscarinic Drugs on Overactive Bladder (OAB) Symptoms After Insertion of Ureteral Stents
|
N/A | |
Completed |
NCT00910520 -
Botulinum Toxin Type A for the Treatment of Patients With Idiopathic Overactive Bladder With Urinary Incontinence
|
Phase 3 |