Clinical Trial to Study a Non-invasive Neurostimulation Device on Urgency (Urinary) Incontinence Overactive Bladder (OAB)

Study Overview
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Brief Summary
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The purpose of this study is to determine whether the non-invasive neurostimulation patch is effective in the treatment of urgency, frequency and urge (urinary) incontinence.

Detailed Description
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While the precise cause of OAB symptoms (urge, frequency, incontinence) is not clear, most physicians and researchers accept the theory that a problem in the communication between the central nervous system and the bladder is a factor. Research has shown that a process called neuromodulation of the nerves controlling the bladder can overcome this communication problem. In patients who have symptoms caused by the communication problem, neuromodulation has been clinically proven to eliminate or significantly reduce those symptoms. While neuromodulation has been previously achieved by implanting an electrode near the sacral nerve in the spine, the new concept under investigation within this protocol is believed to achieve a similar effect from adhesive electrodes placed on the skin over spinal nerves in the lower back.

Official Title
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Pilot Clinical Trial to Study the Effectiveness of a Four-week Exposure to a Transcutaneous, High-frequency, Amplitude-modulated, Non-invasive Neurostimulation Device on Urgency (Urinary) Incontinence in Subjects With Idiopathic Overactive Bladder (OAB)

Conditions
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Overactive Bladder

Intervention / Treatment
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* Device: Non-invasive neurostimulation device
* Device: Non-invasive neurostimulation device


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Potential subjects must satisfy the following criteria in order to be enrolled in the study: Males and Females, at least 18 years of age Documented symptoms of idiopathic overactive bladder for at least 6 months Failure on primary OAB treatment, such as behavior modification or fluid/diet management, AND at least one (1) anti-cholinergic drug An average of one (1) or more urgency (urinary) incontinence episodes per 24-hours, confirmed by the 3-day baseline voiding diary, with a maximum of 12 urgency (urinary) incontinence episodes per 24-hours An average of eight (8) or more voids per 24-hours, confirmed by the 3-day baseline voiding diary Demonstrated ability to adequately complete the 3-day baseline voiding diary Willing and capable of understanding and complying with all requirements of the protocol Signed Informed Consent to participate in the study after full discussion of the research nature of the treatment and its risks and benefits. Exclusion Criteria: Potential subjects who meet any of the following criteria will be excluded from participating in the study: Urinary retention Clinically significant bladder outlet obstruction Morbidly obese, defined as having BMI > 40 kg/m2 Stress predominant mixed urinary incontinence Neurological disease affecting urinary bladder function, including but not limited to Parkinson's disease, multiple sclerosis, stroke, spinal cord injury. History of epilepsy Pelvic surgery (such as sub-urethral sling, pelvic floor repair) within the past 6 months Intravesical or urethral sphincter Botulinum Toxin Type A injections within the past 12 months Failure of previous neuromodulation therapy for overactive bladder Percutaneous Tibial Nerve Stimulation (PTNS) therapy for overactive bladder within the past 6 months Any clinically significant congenital or acquired disorder of the urogenital tract (including denovo OAB following sub-urethral sling) Vaginal prolapse greater than Stage II in the anterior compartment of the vagina using International Continence Society (ICS) Pelvic Organ Prolapse Quantification (POPQ) criteria. Prior peri-urethral or transurethral bulking agent injections for bladder problems within the past 12 months. History of pelvic radiation therapy Any skin conditions affecting treatment or assessment of the treatment sites History of lower back surgery or injury that could impact placement of the patch, or where underlying scar tissue or nerve damage may impact treatment. Unable to operate the device remote control. Lacking dexterity to properly utilize the components of the device system. Presence of an implanted electro-medical device (e.g. pacemaker, defibrillator, InterStim®, etc.), Any metallic implant in the back. Pregnant, nursing, suspected to be pregnant (by urine pregnancy method), or plans to become pregnant during the course of the study. History of dementia or Alzheimer's disease. Known latex allergies Uncontrolled diabetes and/or diabetes with peripheral neuropathy. Transurethral instrumentation within the preceding month. Scheduled for any of the following during the course of the study: Magnetic Resonance Imaging (MRI), Positron Emission Tomography (PET), X-ray, Ultrasound, or Radiotherapy (targeting full body or back region) Recurrent Urinary Tract Infections (>3 UTI's in the past year) Clean catch Urinalysis results >10wbc/hpf History of or current lower tract genitourinary malignancies Any clinically significant systemic disease or condition that in the opinion of the Investigator would make the patient unsuitable for the study

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Investigator Placement Group<br> | Device: Non-invasive neurostimulation device<br>* Active electrode patches are worn for 4 weeks, one per week, during the treatment phase of the study. The patch is placed by the investigator.<br>|
| Active Comparator: Subject Placement Group<br> | Device: Non-invasive neurostimulation device<br>* Active electrode patches are worn for 4 weeks, one per week, during the treatment phase of the study. The patch is placed by the subject.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Mean Daily Urgency Incontinence Episodes | Mean urgency incontinence episodes (or urinary leaks) over 24 hours is based on a 3-day diary maintained by the subject. Urgency incontinence is when a subject has urinary leakage, i.e., uncontrolled release of fluid prior to making it to the bathroom. The number of leaks over 3 days was recorded for each subject at baseline and again at Week 4. The 3-day average at each time point was used as the mean over 24 hours and the change from baseline to Week 4 was calculated for each subject. | From baseline to Week 4 of active treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Mean Daily Voiding Frequency | Mean daily voiding frequency over 24 hours is based on a 3-day diary maintained by the subject. Voiding frequency is defined as the number of times a subject urinates. The number of voids over 3 days was recorded for each subject at baseline and again at Week 4. The 3-day average at each time point was used as the mean over 24 hours and the change from baseline to Week 4 was calculated for each subject. | From baseline to Week 4 of active treatment | 
| Change in Mean Volume Per Void | Mean volume per void (or amount of urine per urination) over 24 hours is based on a 3-day diary maintained by the subject. The volume of void (in milliliters) over 3 days was recorded for each subject at baseline and again at Week 4. The 3-day average at each time point was used as the mean over 24 hours and the change from baseline to Week 4 was calculated for each subject. | From Baseline to Week 4 of active treatment | 
| Change in Mean Urgency Episodes Per Day | Mean urgency episodes per day is based on a 3-day diary maintained by the subject. An urgency episode is identified by the subject as a case where they have a strong urge to urinate, i.e. difficulty controlling the bladder and thus are rushing to the bathroom. The number of urgency episodes over 3 days was recorded for each subject at baseline and again at Week 4. The 3-day average at each time point was used as the mean over 24 hours and the change from baseline to Week 4 was calculated for each subject. | From Baseline to Week 4 of active treatment | 
| Change in Mean Overactive Bladder Symptom Composite Score | The Overactive Bladder Symptom Composite is a composite symptom score of toilet voids, urgency severity and urge urinary incontinence. It combines the Indevus Urgency Severity Scale for capture of urgency severity per toilet void with 24-hour frequency and urinary urge incontinence episodes. A complete reference for this validated measure can be found in teh Journal of Urology, Vol. 173, pgs 1639-1643, May 2005. The scale is specific to the instrument and lower scores represent an improvement in symptoms. The scale is a weighted average of each void a subject has. The weights are assigned as 0=no urgency, 1=mild, 2=moderate, 3=severe. The minimum score is 0, corresponding to no urgency in every void. There is no quantifiable upper limit since the scale is based on the number of voids per day, but there are reasonable upper limits. For example, if a subject had 15 voids in 1 day and all 15 were severe (=3), the Composite Score would be 45. Full details are in the reference above. | From Baseline to Week 4 of active treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Urinary Incontinence, Overactive Bladder, Frequency, Urgency