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Device
Treatment for Overactive Bladder (EVANESCE-OAB Trial)
N/A
Waitlist Available
Research Sponsored by FemPulse Corporation
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up approximately 11 days in total
Summary
The purpose of this clinical trial is to investigate a new medical device treatment for Overactive Bladder (OAB) in women.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ approximately 11 days in total
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~approximately 11 days in total
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
All device- and procedure-related adverse events will be collected and tabulated
Incontinence Impact Questionnaire - Short Form
OAB Symptom Score
+5 moreTrial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: TreatmentExperimental Treatment1 Intervention
FemPulse System at one device setting
Group II: ControlPlacebo Group1 Intervention
FemPulse System at a different device setting
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Who is running the clinical trial?
FemPulse CorporationLead Sponsor
3 Previous Clinical Trials
37 Total Patients Enrolled
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