Biowave Overactive Bladder Trial
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Overactive Bladder |
| Therapuetic Areas: | Gastroenterology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/21/2016 |
| Start Date: | May 2013 |
| End Date: | December 2015 |
Biowave Overactive Bladder (OAB) Trial
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.
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.
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.
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.
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.
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