Urinary Bladder, Overactive Clinical Trial
Official title:
EMED Detruset Intravesical Electrical Stimulation Catheter for Treatment of Urge Urinary Incontinence and Overactive Bladder Syndrome in Females
The pilot study is intended to show the efficacy of intravesical electrical stimulation in treating overactive bladder with or without frequency and/or urgency urinary incontinence.
The EMED Technologies detrusetTM intravesical electrical stimulation (IVES) catheter is
indicated for use with the EMED detrusanTM 500 electrical generator for the treatment of
overactive bladder and urge urinary incontinence (UI) in women who are not satisfied with or
cannot tolerate other conservative treatments. EMED is interested in conducting a
prospective randomized multi-center study of IVES therapy vs conventional UI treatments. In
order to gain sufficient knowledge of the treatment effect and variability of IVES therapy
to power an RCT, a pilot study will be initially conducted.
The pilot study is intended to show the efficacy of IVES in treating overactive bladder with
or without frequency and/or urgency urinary incontinence with safety profile of IVES being
no worse than with standard urological catheters.
A primary endpoint at 3 months showing reduction in incontinence events via a 7-level
patient global impression of improvement will be established. Secondary endpoints will
include PCI for subsets of symptoms, 3 day voiding diary, and patient satisfaction
questionnaires.
Follow up at end of therapy and 3 months from the first therapy session will be conducted.
6-month, 9-month, and 12-month follow up can be conducted to establish durability of IVES
therapy if it is found to be effective at 3 months after the first treatment
;
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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