safety and effectiveness of a non-invasive neuromodulation device on urgency urinary incontinence in overactive bladder

Conditions: Overactive Bladder

Summary: 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).


Eligibility criteria:
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.

Keywords: urinary incontinence overactive bladder frequency urgency