Palo Alto, California 94304

  • Overactive Bladder

Purpose:

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.


Criteria:

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


NCT ID:

NCT03595215


Primary Contact:

N/A


Backup Contact:

N/A


Location Contact:

Palo Alto, California 94304
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: June 21, 2021

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