Clinical Evaluation of Fractional Bi-Polar Radio-Frequency for Symptoms of Stress Urinary Incontinence and Vulvovaginal Atrophy
The objective of this trial is to evaluate the safety and efficacy of the MorpheusV Applicator for Symptoms of Stress Urinary Incontinence and Vulvovaginal Atrophy
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
41
1 treatment with the MorpheusV Applicator
Miklos and Moore Urogynecology
Alpharetta, Georgia, United States
Advanced Women's Care of the Lowcountry, PC
Bluffton, South Carolina, United States
An objective change as measured by standardized cough stress test
An objective change as measured by standardized cough stress test performed in standing position before treatment and at 6 months (6M FU) after the treatment
Time frame: Day 0, Month 6
An objective evaluation of vaginal atrophy/estrogenization
An objective evaluation of vaginal atrophy/estrogenization measured by the globally validated "Vaginal Health Index" (VHI) score at 6M FU compared to Baseline.
Time frame: Day 0, month 6
The effect of the treatment on urinary symptoms and quality of life by means of the Incontinence 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. Administered at baseline and at 6M FU.
Time frame: Day 0, month 6
The effect of the treatment on urinary symptoms by means of Urogenital Distress Inventory 6 Questionnaire
The effect of the treatment on urinary symptoms by means of Urogenital Distress Inventory 6 Questionnaire. Administered at baseline and at 6M FU.
Time frame: day 0, month 6
The effect of the treatment on urinary symptoms by means of Bladder voiding diary after the treatment
The effect of the treatment on urinary symptoms by means of Bladder voiding diary after the treatment, and at 6M FU versus baseline.
Time frame: Day 0, month 6
The effect of the treatment on urinary symptoms by means of 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 at 6M FU versus baseline.
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Time frame: Day 0, month 6
Evaluation of histological changes to vaginal canal tissue
Evaluation of histological changes to vaginal canal tissue taken immediately post treatment and at 3M FU versus baseline. (for 5 subjects)
Time frame: Day 0, month 3
Occurrence of expected post treatment immediate response
Occurrence of expected post treatment immediate response including erythema and edema and during all study period based on predefined scale
Time frame: day 0, through study completion, on average 6 months
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 energy application
Time frame: day 0
Adverse Events
Number, severity and type of any adverse event recorded throughout the course of the study.
Time frame: Through study completion, an average of 6 months