Biowave Overactive Bladder (OAB) Trial
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Overactive Bladder
- Sponsor
- Kenneth Peters, MD
- Enrollment
- 8
- Locations
- 1
- Primary Endpoint
- Global Response Assessment (GRA)
- Status
- Completed
- Last Updated
- 9 years ago
Overview
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.
Investigators
Kenneth Peters, MD
Chairman, Department of Urology
William Beaumont Hospitals
Eligibility Criteria
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)
Outcomes
Primary Outcomes
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.