eCoin Tibial Nerve Stimulation for OAB

Inclusion Criteria

• Women and men 18 years and older.
• Diagnosis of overactive bladder with urgency urinary incontinence or mixed urge and stress incontinence with a predominant urgency component, for at least 6 months (self-reported).
• Individual has at least four urgency incontinence episodes on a three-day voiding diary with at least one episode per 24 hour time period
• Individual with urinary frequency, defined as an average of greater than or equal to 8 times/24 hours (ie. a total of greater than or equal to 24 micturitions on a 3 day diary)
• Individual is unresponsive to, inadequately responsive to, or intolerant of behavioral, rehabilitation, and pharmacologic therapy.
• Individual is able to give his or her written, informed consent.
• Individual is mentally competent and able to understand all study requirements.
• Individual is willing and able to complete a 3-day voiding diary and quality of life questionnaire.
• Individual is without pharmacological treatment of overactive bladder (antimuscarinics and beta-3 agonists) for 2 weeks prior to screening.
• The individual demonstrates a positive nerve integrity test.

Exclusion Criteria

• Individual has predominantly stress urinary incontinence
• Individual has clinically significant bladder outlet obstruction.
• Individual has clinically significant pelvic organ prolapse.
• Individual has abnormal post void residual (i.e., greater than 150 cc).
• Individual has clinically significant urethral stricture disease or bladder neck contracture
• Individual has an active urinary tract infection at time of enrollment.
• Individual has recurrent urinary tract infections defined as 4 or more UTI's per year.
• Individual has morbid obesity.
• Individual has had positive urine cytology or diagnosis of bladder or prostate cancer.
• Individual has neurogenic bladder dysfunction.
• Individual is taking an alpha-blocker for benign prostatic hyperplasia.
• Individual is pregnant or intends to become pregnant during the study.
• Patient is breast feeding or is less than 9-month post-partum.
• Individual has the presence of urinary fistula, bladder stone, or interstitial cystitis.
• Individual has uncontrolled diabetes mellitus.
• Individual has a cardiac pacemaker or implanted defibrillator.
• Individual has been previously treated with sacral nerve stimulation.
• Individual has been treated with onabotulinumtoxinA in the previous 9 months prior to enrollment.
• Individual has been treated with percutaneous tibial nerve stimulation within the previous 12 weeks prior to enrollment.
• Individual requires regular Magnetic Resonance Imaging for other health care conditions. (ASK)
• Individual has a clotting or bleeding disorder; antiplatelet and anticoagulant therapy may be continued or held at the discretion of the investigator
• Individual has a clinically significant peripheral neuropathy.
• Individual is neutropenic or immunocompromised.