Overactive Bladder
Conditions
Brief summary
To evaluate the safety and durability of the TheraNova Neuromodulation System in overactive bladder (OAB) patients.
Interventions
DEVICETheraNova Neuromodulation Device
TENS device
Sponsors
Theranova, L.L.C.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Individual completed the clinical study Evaluation of the TheraNova Neuromodulation System for the Treatment of Overactive Bladder Symptoms (Protocol Number CRD-10-1330-01) as a subject in the Active Treatment group * Individual has at least ≥4 incontinence events with associated moderate or severe urgency (UUI events), with at least one UUI event per day, as recorded in the baseline 3-day voiding diary at week 0 of the clinical study Evaluation of the TheraNova Neuromodulation System for the Treatment of Overactive Bladder Symptoms (Protocol Number CRD-10- 1330-01) * Individual is ambulatory and able to use the toilet independently * Individual has not taken antimuscarinics, anticholinergics, beta-3 agonists, alpha blockers, 5-alpha reductase inhibitors, vasopressin analogues, tricyclic antidepressants, or phenazopyridine for at least 2 weeks prior to enrollment * Individual is not taking diuretics or has been on a steady dose of diuretics for at least 3 months * Individual is able to provide informed consent * Individual is capable and willing to follow all study-related procedures
Exclusion criteria
* Individual has recurrent UTI defined as ≥4 UTIs in the past 12 months * Female of childbearing age (≤50 years old) who is pregnant as confirmed by urine pregnancy test, or who plans to become pregnant during the study period * Individual has peripheral arterial disease * Individual has the presence of a urinary fistula, bladder stone, or interstitial cystitis * Individual has a diagnosis of prostate, urethral, or bladder cancer * Individual has morbid obesity (BMI ≥ 40) * Individual has clinically significant urethral stricture disease or bladder neck contracture * Individual has a metallic implant that is exposed above the bone surface (e.g. a bone fracture fixation plate, but not an embedded bone screw) and is located under the skin on the bottom of the foot for either foot or under the skin on the anterior aspect of the mid-thigh for either leg. * Individual has an implanted electrical and/or neurostimulator device (e.g. pacemaker, defibrillator, vagal neurostimulator, deep brain stimulator, spinal stimulator, sacral stimulator, bone growth stimulator, or cochlear implant) * Individual has been treated with percutaneous tibial nerve stimulation or pelvic floor muscle stimulation * Individual has been treated with onabotulinumtoxinA in the past 9 months * Individual has a clinically significant peripheral neuropathy * Individual has a history of pelvic pain as primary diagnosis in the past 12 months (VAS score of \>4 (scale of 0 to 10)) Individual has neurogenic bladder (i.e. Multiple Sclerosis, Parkinson's, Spinal Cord Injury) * Individual has used an investigational drug, biologic, or medical device in the past 4 weeks * Individual is deemed unsuitable for enrollment in the study by the investigator based on the subject's history or physical examination
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| UUIs | 12 weeks | change in the mean number of urge urinary incontinence (UUI) episodes per day from week 12 to week 24 (this study starts at 12 weeks) |
Countries
United States
Outcome results
None listed