Prospective, one arm, baseline-controlled At least 30 healthy adult female volunteers, from 2 investigational sites seeking treatment for Symptoms of Vulvovaginal Atrophy Eligible subjects will receive 3 treatments 4 weeks apart with the MorpheusV Applicator according to the study protocol The subject will return for 3 follow up visits: 3 months follow up (3M FU), 6 months follow up (6M FU), 12months follow up (12M FU) after the treatment. Total expected study duration is approximately 12 months.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
30
Eligible subjects will receive 3 treatments 4 weeks apart with the MorpheusV Applicator according to the study protocol
Beyond Regenerative Medicine and Aesthetics
Newport Beach, California, United States
Institute for Female Pelvic Medicine
Knoxville, Tennessee, United States
effect of treatment on VVA symptoms,
effect of treatment on VVA symptoms, such as pain, vaginal burning, vaginal itching, dyspareunia and dysuria, using the Visual Analog Scale (VAS). scored from 1 to 10, the lower the score the better the outcome
Time frame: baseline through 12 months
objective evaluation of vaginal atrophy/estrogenization
measured by the globally validated "Vaginal Health Index" (VHI) score at follow up visits 3M, 6M FU and 12M FU) compared to Baseline. Scored from 5 to 25, the higher the score the better the outcome
Time frame: baseline through 12 months
Assess the effect of treatment on the general quality of life,
by mean of the "Short Form 12" (SF-12) specific questionnaire. Administered at baseline and at follow up visits 3M, 6M and 12M FU).
Time frame: baseline through 12 months
The effect of the treatment on Sexual Function
measured by Female Sexual Function Index (FSFI) at follow up visits (3M FU,6M FU and 12M FU) compared to baseline. the higher the score the better the outcome
Time frame: baseline through 12 months
Assess the degree of difficulty encountered by the physician in performing the treatment,
by mean of a 5-point Likert scale. the higher the score the better the outcome
Time frame: baseline through 12 months
The rate of satisfaction of patients with treatment
assessed by the Patient Global Impression of Improvement (PGI), using a 5-point Likert scale. The subjects will answer this questionnaire at follow up visits 3M FU, 6M and 12M FU). the higher the score the better the outcome
Time frame: baseline through 12 months
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The effect of the treatment on urinary symptoms
by means of Urogenital Distress Inventory 6 Questionnaire. Administered at baseline and at each follow up visit (3M FU, 6M FU, 12M FU). the lower the score the better the outcome
Time frame: baseline through 12 months
Occurrence of expected post-treatment adverse events
Occurrence of expected post treatment immediate response including erythema and edema and during all study period based on predefined scale
Time frame: up to 12 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 at the treatment visit
Time frame: up to 3 months
Adverse events
Number, severity and type of any adverse event recorded throughout the course of the study.
Time frame: baseline through 12 months