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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
Study Summary
The objective of this trial is to evaluate the safety and efficacy of the combined FormaV and VTone Applicators for Symptoms of Mixed Urinary Incontinence. Eligible subjects will receive 3 treatments(every 2 weeks) with the FormaV and VTone Applicators according to the study protocol. The subject will return for 3 follow-up visits: 4 weeks (1M FU), 3 months follow up (3M FU), 6 months follow up (6M FU) after the treatment.
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
23 Previous Clinical Trials
1,334 Total Patients Enrolled
2 Trials studying Urinary Incontinence
91 Patients Enrolled for Urinary Incontinence
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Who else is applying?
What state do they live in?
Nevada
How old are they?
18 - 65
What portion of applicants met pre-screening criteria?
Did not meet criteria
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