Urinary Incontinence
Conditions
Brief 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.
Interventions
DEVICEFormaV and VTone
Eligible subjects will receive 3 treatments(every 2 weeks) with the FormaV and VTone Applicators according to the study protocol.
Sponsors
InMode MD Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
20 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Signed informed consent to participate in the study. * Female subjects, 20 to 75 years of age at the time of enrolment with moderate to severe symptoms of MUI, who had scored a relative even proportion of urge and stress subscale scores on the Medical, Epidemiologic, and Social Aspects of Aging Urinary Incontinence (MESA) Questionnaire completed at the screening assessment * General good health confirmed by medical history and examination of the treated area. * The patients should be willing to comply with the study procedure and schedule, including the follow up visit, and will refrain from using any other aesthetic treatment methods for the last 6 months and during the entire study period.
Exclusion criteria
7.5
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Patient Global Impression of Improvement (PGI), using a 5-point Likert scale | month 6 | The rate of satisfaction of patients with treatment assessed by the Patient Global Impression of Improvement (PGI), using a 5-point Likert scale |
| Urogenital Distress Inventory 6 Questionnaire | baseline through month 6 | The effect of the treatment on urinary symptoms by means of Urogenital Distress Inventory 6 Questionnaire |
| Medical, Epidemiologic, and Social Aspects of Aging Urinary Incontinence (MESA) Questionnaire | baseline through month 6 | The effect of the treatment on urinary symptoms by means of Medical, Epidemiologic, and Social Aspects of Aging Urinary Incontinence (MESA) Questionnaire ( |
| Cough stress test | Baseline through month 6 | Change as measured by standardized cough stress test performed in standing position before treatment and 6 months after the treatment |
| Quality of Life (IQOL) Questionnaire | baseline through month 6 | The effect of the treatment on urinary symptoms and quality of life by means of the Incontinence Quality of Life (IQOL) Questionnaire. |
| Female Sexual Function Index questionnaire | baseline through month 6 | The effect of the treatment on female sexual function by means of Female Sexual Function Index |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Adverse events | throughout the study | Number, severity and type of any adverse event recorded throughout the course of the study. |
| Discomfort scale | post treatment | A 10cm visual analog scale from 0 (no discomfort) to 10 (worst possible discomfort) to measure discomfort associated with probe insertion, and RF/EMS energy application at the treatment visit |
Countries
United States
Outcome results
None listed