This trial is active, not recruiting.

Condition overactive bladder
Treatment biowave treatment
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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Endpoint classification efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Six weekly treatments
biowave treatment
Six weekly treatments

Primary Outcomes

Global Response Assessment (GRA)
time frame: 3 months

Eligibility Criteria

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.

Additional Information

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.
Trial information was received from ClinicalTrials.gov and was last updated in October 2015.
Information provided to ClinicalTrials.gov by William Beaumont Hospitals.