Palo Alto, California 94304

  • Overactive Bladder


This pilot clinical study, which focuses on feasibility and proof-of-principle, will be conducted in 11 female subjects (55-100 years old) with UI. Subjects will use the device three times a week for 8 weeks and complete 3-day "voiding diaries" to record instances of UI episodes and OAB quality of life.


Inclusion Criteria: 1. Females 2. 55-100 years old 3. Have an average urinary frequency of ≥ 8 voids per 24 hours (based on a pre-treatment 3-day voiding "training" diary) 4. Have self-reported bladder symptoms of more than 3 months 5. Are ambulatory and able to use the toilet independently 6. Have been off antimuscarinics, anticholinergics or beta-3 agonists for at least 2 weeks prior to enrollment OR on a stable dose for the prior 3 months 7. Patient has urinary urge incontinence of ≥ 8 episodes from a 3-day diary (with incontinence associated at urge level moderate or severe) 8. Able to provide informed consent 9. Capable and willing to follow all study-related procedures Exclusion Criteria: 1. Have primary complaint of stress urinary incontinence 2. Have a pacemaker or implantable defibrillator 3. Had botox injections in the bladder or pelvic floor muscles in the past 12 months 4. Have a current urinary tract or vaginal infection 5. Have an active implantable SNS device (InterStim & Bion) 6. Have been diagnosed with peripheral neuropathy or nerve damage 7. Currently pregnant 8. Deemed unsuitable for enrollment in study by the investigator based on subjects' history or physical examination



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Palo Alto, California 94304
United States

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Site Status: N/A

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Date Processed: June 21, 2021

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