Clinical trial NCT01848366: Utilization of the BIOWAVE Device to Treat Overactive Bladder
Official title: Biowave Overactive Bladder (OAB) Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Overactive Bladder
Keywords: Frequency
urgency
incontinence
Lead sponsor: William Beaumont Hospitals
Sponsor class: OTHER
First posted: 2013-05-07
Enrollment: 8
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Global Response Assessment (GRA)
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Royal Oak
country: United States
facility: William Beaumont Hospital
state: Michigan
Study officials:
affiliation: William Beaumont Hospitals
name: Kenneth M Peters, MD
role: PRINCIPAL_INVESTIGATOR
References: