Utilization of the BIOWAVE Device to Treat Overactive Bladder

Biowave Overactive Bladder (OAB) Trial

Demonstrate a response to stimulation of the posterior tibial nerve using the Biowave device and a microneedle patch electrode in patients with overactive bladder symptoms. The investigators hypothesize that after at least 6 weekly treatments there will be modest improvements in overactive bladder symptoms trending toward more improvement.

Women 18 years old and over with a score of equal to or greater than 4 on the OAB-q short form for urgency and average daily urinary frequency equal to or greater than 10 times based on a 3-day voiding diary plus other inclusion criteria will be reviewed for possible enrollment in this study. Outcomes measured include Global Response Assessment (GRA) for overall bladder symptoms, a change in the 3-day voiding diary parameters and adverse events.

Inclusion Criteria:

• Women >18 years of age
• A score of > 4 on the OAB-q short form for urgency (question 1)
• Average daily urinary frequency > 10 times based on a 3-day voiding diary
• Self-reported bladder symptoms present > 3 months
• Self-reported failed conservative care (i.e., dietary restriction, fluid restriction, bladder training, behavioral modification, pelvic muscle training, biofeedback, etc.)
• Off all antimuscarinics for at least 2 weeks prior to enrollment
• Capable of giving informed consent
• Ambulatory and able to use a toilet independently, without difficulty
• Capable and willing to follow all study-related procedures

Exclusion Criteria:

• Pregnant as confirmed by urine pregnancy test, or plans to become pregnant during the study period
• Neurogenic bladder
• Botox® use in bladder or pelvic floor muscles in the past year
• Pacemakers or implantable defibrillators
• Primary complaint of stress urinary incontinence
• Current urinary tract infection (UTI)
• Current vaginal infection
• Current use of InterStim®
• Current use of Bion®
• Previously been treated with Percutaneous Tibial Nerve Stimulation (PTNS)
• Use of investigational drug/device therapy within the past 4 weeks.
• Participating or have participated within the past 4 weeks in any clinical investigation involving or impacting gynecologic, urinary or renal function.
• Deemed unsuitable for enrollment in study by the investigators based on subjects' history or physical examination (including skin disorders at the treatment site or peripheral neuropathy).
• Subjects with nerve damage that would impact either percutaneous tibial nerve or pelvic floor function.