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Electrical Stimulation
treatment for Urinary Incontinence
N/A
Waitlist Available
Research Sponsored by InMode MD Ltd.
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 month 6
Awards & highlights
Summary
This trial is testing the safety and effectiveness of two devices, FormaV and VTone, for treating mixed urinary incontinence. FormaV tightens tissues using heat, while VTone strengthens pelvic muscles with electrical stimulation. The goal is to reduce urinary leakage in patients who have both stress and urge incontinence.
Eligible Conditions
- Urinary Incontinence
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ month 6
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~month 6
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Cough stress test
Female Sexual Function Index questionnaire
Medical, Epidemiologic, and Social Aspects of Aging Urinary Incontinence (MESA) Questionnaire
+3 moreSecondary outcome measures
Adverse events
Discomfort scale
Trial Design
1Treatment groups
Experimental Treatment
Group I: treatmentExperimental Treatment1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
FormaV and VTone
2021
N/A
~40
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Who is running the clinical trial?
InMode MD Ltd.Lead Sponsor
24 Previous Clinical Trials
1,359 Total Patients Enrolled
2 Trials studying Urinary Incontinence
91 Patients Enrolled for Urinary Incontinence
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