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Bi-Polar Radio-Frequency and Electrical Muscle Stimulation for Symptoms of Mixed Urinary Incontinence (MUI)

NCT05287490 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 31

Last updated 2022-08-11

No results posted yet for this 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.

Conditions

Interventions

DEVICE

FormaV and VTone

Eligible subjects will receive 3 treatments(every 2 weeks) with the FormaV and VTone Applicators according to the study protocol.

Sponsors & Collaborators

  • InMode MD Ltd.

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
20 Years
Max Age
75 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-04-04
Primary Completion
2022-07-30
Completion
2022-07-30
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05287490 on ClinicalTrials.gov