Status:
COMPLETED
Utilization of the BIOWAVE Device to Treat Overactive Bladder
Lead Sponsor:
Kenneth Peters, MD
Conditions:
Overactive Bladder
Eligibility:
FEMALE
18+ years
Phase:
NA
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 hypothesi...
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 voidin...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
May 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2014
Estimated Enrollment :
8 Patients enrolled
Trial Details
Trial ID
NCT01848366
Start Date
May 1 2013
End Date
August 1 2014
Last Update
December 7 2016
Active Locations (1)
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1
William Beaumont Hospital
Royal Oak, Michigan, United States, 48073