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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
31
Eligible subjects will receive 3 treatments(every 2 weeks) with the FormaV and VTone Applicators according to the study protocol.
Advanced Women's Care of the Lowcountry, PC
Bluffton, South Carolina, United States
Lisa M Jukes MD
West Lake Hills, Texas, United States
Cough stress test
Change as measured by standardized cough stress test performed in standing position before treatment and 6 months after the treatment
Time frame: Baseline through month 6
Quality of Life (IQOL) Questionnaire
The effect of the treatment on urinary symptoms and quality of life by means of the Incontinence Quality of Life (IQOL) Questionnaire.
Time frame: baseline through month 6
Female Sexual Function Index questionnaire
The effect of the treatment on female sexual function by means of Female Sexual Function Index
Time frame: baseline through month 6
Urogenital Distress Inventory 6 Questionnaire
The effect of the treatment on urinary symptoms by means of Urogenital Distress Inventory 6 Questionnaire
Time frame: baseline through month 6
Medical, Epidemiologic, and Social Aspects of Aging Urinary Incontinence (MESA) Questionnaire
The effect of the treatment on urinary symptoms by means of Medical, Epidemiologic, and Social Aspects of Aging Urinary Incontinence (MESA) Questionnaire (
Time frame: baseline through month 6
Patient Global Impression of Improvement (PGI), using a 5-point Likert scale
The rate of satisfaction of patients with treatment assessed by the Patient Global Impression of Improvement (PGI), using a 5-point Likert scale
Time frame: month 6
Discomfort scale
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
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: post treatment
Adverse events
Number, severity and type of any adverse event recorded throughout the course of the study.
Time frame: throughout the study