Safety and Effectiveness of a Non-invasive Neuromodulation Device on Urgency Urinary Incontinence in Overactive Bladder (Beacon)

• Measure decrease in mean urinary frequency [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  Evaluate the 12 week change from baseline in decrease of mean urinary frequency between the active and sham treatment groups
• Measure increase in mean volume per void [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  Evaluate the 12 week change from baseline in mean volume per void between the active and sham treatment groups
• Measure decrease in mean urgency episodes [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  Evaluate the 12 week change from baseline in mean urgency episodes between the active and sham treatment groups
• Measure improvement in mean OAB-Symptom Composite score [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  Evaluate the 12 week change from baseline improvement in mean OAB-Symptom Composite score between the active and sham treatment groups

The purpose of this study is to evaluate the change from baseline between the active and sham treatment groups in the treatment of urgency (urinary) incontinence episodes (leaks).

• Device: (VERV™ System)
  Active electrode patches are worn for 12 weeks, one per week. The patch is placed by the subject. All subjects will have access to active patches for 9 months after the sham-controlled 12-week portion of the study is complete.
  Other Name: Non-invasive neurostimulation device
• Device: Sham version of (VERV™ System)
  Inactive (sham) electrode patches are worn for 12 weeks, one per week. The patch is placed by the subject. All subjects will have access to active patches for 9 months after the sham-controlled 12-week portion of the study is complete.
  Other Name: Inactive Non-invasive neurostimulation device

• Active Comparator: Active Treatment group
  Intervention: Device: (VERV™ System)
• Sham Comparator: Sham Treatment Group
  Intervention: Device: Sham version of (VERV™ System)

Inclusion Criteria:

• Males and Females, at least 18 years of age
• Failure on primary OAB treatment, such as behavior modification or fluid/diet management, AND at least one (1) anti-cholinergic drug (unless patient was contra-indicated for anti-cholinergic use)
• Symptoms of overactive bladder for at least 6 months
• An average of one (1) or more urgency (urinary) incontinence episodes per 24-hours, over a 3-day period, confirmed by the 3-day baseline voiding diary, with a maximum of 12 urgency (urinary) incontinence episodes per 24-hours
• Dexterity and ability to place and operate the device
• Females of child-bearing capability agrees to use a reliable form of birth control for the duration of the trial
• An average of eight (8) or more voids per 24-hours, over a 3-day period, confirmed by the 3-day baseline voiding diary
• Willing and capable of understanding and complying with all requirements of the protocol, including proper completion of the baseline voiding diary
• Signed and dated the IRB-approved Informed Consent document.

Exclusion Criteria:

• Dysfunctional voiding symptoms unrelated to OAB, such as clinically significant bladder outlet obstruction, and urinary retention (pvr > 100 cc)
• Morbidly obese, defined as having Body Mass Index (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 and uncontrolled 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
• Any neuromodulation therapy for overactive bladder within the past 3 months
• Failure to respond to previous neuromodulation therapy for overactive bladder
• Leading edge of any vaginal prolapse is beyond hymenel ring.
• Prior peri-urethral or transurethral bulking agent injections for bladder problems within the past 12 months.
• 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.
• Presence of an implanted electro-medical device (e.g. pacemaker, defibrillator, InterStim®, etc.), or any metallic implant in the lower back.
• Pregnant, nursing, suspected to be pregnant (by urine pregnancy method), or plans to become pregnant during the course of the study.
• Known latex allergies, or allergies or hypersensitivity to patch materials that will be in contact with the body (e.g., hydrogel, acrylic-based adhesive, polyurethane).
• Uncontrolled diabetes and/or diabetes with peripheral neuropathy.
• Current Urinary Tract Infection (UTI) or history of recurrent UTIs (>3 UTIs in the past year).
• History of lower tract genitourinary malignancies within the last 6 months or any previous pelvic radiation.
• Any clinically significant systemic disease or condition that in the opinion of the Investigator would make the patient unsuitable for the study.

• Novella Clinical, Inc.
• Data & Inference, Inc.