Utilization of the BIOWAVE Device to Treat Overactive Bladder

Not Applicable

Completed

Brief Summary: 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.

Detailed Description: 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.

Recruitment & Eligibility

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.

Arm && Interventions

Group	Intervention	Description
Biowave Treatment	Biowave Treatment	Twelve weekly treatments

Primary Outcome Measures

Name	Time	Method
Global Response Assessment (GRA)	3 months	The GRA will be used to assess for changes in urinary condition and symptoms after 12 weekly BIOWAVE treatments. The GRA asks the participant to indicate how their condition or symptoms have changed compared to when they started the study. Eight questions addressed bladder symptoms, urine leakage related to activity, urine leakage associated with urge, urinary frequency, Interstitial Cystitis/Painful Bladder Syndrome (IC/BPS), fecal incontinence, and irritable bowel syndrome. Responses range from 1=Markedly Worse to 7=Markedly Improved.

Secondary Outcome Measures