NL-OMON55598
Recruiting
Not Applicable
A prospective study to assess the efficacy and safety of the BlueWind RENOVA iStim* System for the treatment of patients diagnosed with overactive bladder (OASIS - OverActive bladder StImulation System study) - BlueWind RENOVA iStim* System for the treatment of OAB
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Overactive bladder
- Sponsor
- BlueWind Medical Ltd.
- Enrollment
- 25
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •2 \- Female aged 18 or greater (21 or greater in the US), with no plans to
- •become pregnant
- •during the trial; if of bearing potential, negative pregnancy test and
- •if sexually active, using
- •acceptable contraception.
- •4 \- Diagnosis of UUI demonstrated on a 7\-consecutive days voiding diary
- •a minimum of nine (9\) leaking episodes associated with urgency with at
- •least one episode per
- •day for 5 days.
- •5 \- More than or equal to 6 months history of UUI diagnosis
Exclusion Criteria
- •1 \- Previous participation in another study with any investigational drug or
- •within the past 90 days
- •5 \- Any significant medical condition that is likely to interfere with study
- •procedures,
- •device operation, or likely to confound evaluation of study endpoints
- •19 \- More than minimal level of stress incontinence or mixed incontinence
- •with stress
- •component likely to confound study outcome, based on a 7\-day voiding
- •diary or medical history,or when stress incontinence score in the MESA
- •incontinence questionnaire is higher than the urgency incontinence score
Outcomes
Primary Outcomes
Not specified
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