Peripheral Electrical Stimulation for the Treatment of Overactive Bladder

Peripheral Electrical Stimulation for the Treatment of Overactive Bladder

This clinical trial testing three different sites of transcutaneous electrical nerve stimulation for the treatment of overactive bladder (OAB).

Inclusion Criteria:

• Males and Females, at least 18 years of age
• Documented symptoms of idiopathic overactive bladder for at least 3 months
• Failure on primary OAB treatment, such as behavior modification or fluid/diet management
• Patients can remain on stable medication
• 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:

• Urinary retention or post voiding residual greater than 100 ml
• Clinically significant bladder outlet obstruction
• 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.
• Pelvic surgery (such as sub-urethral sling, pelvic floor repair) within the past 6 months
• Denovo OAB following pelvic surgery sub-urethral sling Intravesical or urethral sphincter Botulinum Toxin Type A injections within the past 6 months
• Percutaneous Tibial Nerve Stimulation (PTNS) therapy for overactive bladder within the past 6 months
• Any form of electric stimulation to the pelvis or lower limbs within 4 weeks
• Vaginal prolapse greater than Stage II in the anterior compartment of the vagina using International Continence Society (ICS) Pelvic Organ ProlapseQuantification (POPQ) criteria.
• Prior periurethral or transurethral bulking agent injections for bladder problems within the past 12 months.
• History of pelvic radiation therapy
• Any skin conditions affecting treatment sites
• Lacking dexterity to properly utilize the components of the stimulator system.
• Presence of an implanted electro-medical device (e.g. pacemaker, defibrillator, InterStim®, etc.),
• Pregnant, nursing, suspected to be pregnant (by urine pregnancy method), or plans to become pregnant during the course of the study.
• Recurrent Urinary Tract Infections UTI (>3 UTI's in the past year)
• 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
• Any other clinical trial within 6 months