Biowave Overactive Bladder Trial
This trial is active, not recruiting.
|Sponsor||Kenneth Peters, MD|
|Start date||May 2013|
|End date||December 2015|
|Trial size||20 participants|
|Trial identifier||NCT01848366, 2013-034|
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.
|Endpoint classification||efficacy study|
|Intervention model||single group assignment|
Six weekly treatments
Global Response Assessment (GRA)
time frame: 3 months
Female participants at least 18 years old.
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.
|Official title||Biowave Overactive Bladder (OAB) Trial|
|Principal investigator||Kenneth M Peters, MD|
|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.|
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