FREEOAB Study for Overactive Bladder (NCT04547920) | Clinical Trial Compass
CompletedNot Applicable
FREEOAB Study for Overactive Bladder
United States96 participantsStarted 2021-01-11
Plain-language summary
This is a prospective, multicenter study that was conducted to evaluate the safety and efficacy of a novel, closed-loop, continuous-sensing wearable neuromodulation system for Overactive Bladder symptom control.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Male or female and 18 years of age or older at the time of enrollment
✓. Willing and capable of giving informed consent
✓. Willing and able to comply with study-related requirements and procedures
✓. Are an appropriate candidate for the system required in this study based on the clinical judgment of the Investigator.
✓. Have been diagnosed or have symptoms of OAB for at least 3 months Page 8 of 30 Version 1.0 dated July 06, 2020 prior to enrollment
✓. Have an average of 10 or more frequency events per day in a 3-Day Voiding Diary
✓. Able to provide clear, thoughtful responses to questions and questionnaires
✓. Able to toilet self and have and maintain personal hygiene
Exclusion criteria
✕. Have evidence of an active disruptive psychological or psychiatric disorder or other known condition significant enough to impact perception of pain, compliance of intervention and/or ability to evaluate treatment outcomes, in the opinion of the investigator.
✕. Allergic, or have shown hypersensitivity, to any materials of the system which come into contact with the body
✕. Have a pacemaker or implanted defibrillator
✕. Have a documented current or reoccurring Urinary Tract Infection (3 or more in the 12months prior to enrollment)
What they're measuring
1
Percentage of Responders in Voiding (Urinary Frequency) Events