Utilization of the BIOWAVE Device to Treat Overactive Bladder (OAB)
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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.
Condition or disease
Device: Biowave Treatment
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.
Global Response Assessment (GRA) [ Time Frame: 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.
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Layout table for eligibility information
Ages Eligible for Study:
18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
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