Utilization of the BIOWAVE Device to Treat Overactive Bladder

Launched by KENNETH PETERS, MD · May 6, 2013

Keywords

ClinConnect Summary

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.

Gender

FEMALE

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)
• • 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.