Utilization of the BIOWAVE Device to Treat Overactive Bladder

Study Overview
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Brief Summary
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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
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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.

Official Title
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Biowave Overactive Bladder (OAB) Trial

Conditions
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Overactive Bladder

Intervention / Treatment
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* Device: Biowave Treatment


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Biowave Treatment<br>Twelve weekly treatments | Device: Biowave Treatment<br>* Twelve weekly treatments<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Global Response Assessment (GRA) | 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. | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Frequency, urgency, incontinence