POST-MARKETING CLINICAL STUDY to EVALUATE the EFFICACY and SAFETY of the VAGINAL FILLER MEDICAL DEVICE in CORRECTING THINNING of the GENITAL TISSUE of the LABIA MAJORA in WOMEN, RE-PROPORTIONING the FEMALE EXTERNAL GENITAL AREA and IMPROVING SEXUAL FUNCTION.

The Female Sexual Function Index (FSFI) will be used to evaluate the improvement of sexual functions at each study visit, comparing the results between the treatment and the control group. This questionnaire consists of 19 questions addressed to the patient, who can answer with a score from 0 or 1 (worst result) to 5 (best result). At baseline visit V0, the FSFI will be evaluated pre-injection; the pre-injection scores will be considered as baseline value.

Subjects' Quality of Life (QoL) will be assessed at each study visit using the Perceived Stress Scale (PSS), comparing the results between the treatment and the control group. This questionnaire consists of 10 questions addressed to the patient, who can answer with a score from 0 (never) to 5 (usually).

Labia minora hypertrophy classification will be performed using the S. Motakef Classification at each visit. Labial protrusion will be assessed measuring, with the help of tweezers and a ruler, the distance of the lateral edge of the labia minora from that of the labia majora. Three classes of labial protrusion could be identified: class I protrusion from 0 to 2 cm, class II , from 2 to 4 cm, and class III ,protrusion >4 cm. At V0, labial protrusion will be evaluated pre and post injection; the pre-injection score will be considered as baseline value.

The change in the Global Aesthetic Improvement Scale (GAIS) between the treatment and the control group will be utilized to assess the performance of Vaginal Filler for vulvar reshaping. For evaluation of the GAIS, 2D photographs will be taken using an I-phone with standardized settings. Subjects should be photographed in frontal gynecological position and at 45° right and left and cranio-caudal orientation as well as in frontal upright position.

The GAIS is a five-point scale for assessing global aesthetic improvement, where a score of 1 corresponds to the optimal cosmetic result and 5 to a worsening of appearance compared to the original condition.

At V0, the GAIS will be evaluated pre and post injection; the pre-injection scores will be considered as baseline value. The GAIS will be completed independently by both the subjects and the physician investigators.

The Visual Analog Scale (VAS) will be used to assess the impact of Vaginal Filler on the symptoms of vulvar atrophy and hypotrophy at each visit. VAS is a straight horizontal line of fixed length (100 mm). The ends are defined as the extreme limits of the parameter to be measured (improvement of symptoms related to vulvar hypotrophy and atrophy) orientated from the left (0 - No improvement in symptoms) to the right (10 - Maximum improvement of symptoms). The patient should mark with a vertical line a point from 0 to 10 based on the perceived improvement in symptoms. The investigator will then measure the distance between the score 0 and the mark made by the patient with a 10-cm ruler and record the data in digits to one decimal place.

The VAS score of the treatment group will be compared with the score of the control.

To evaluate pain intensity after injection of Vaginal Filler, a Numerical Rating Scale (NRS) will be used at baseline visit V0. Only patients in the treatment group will be asked to fill out the NRS, selecting a number from 0 to 10 indicating the degree of pain experienced after the injection (0 - No pain; 10 - The most intense pain imaginable).

The NRS can be administered verbally soon after the injection and by telephone after the injection in the case the anesthetic will be used. In this case, the Investigator should wait until the effect of the anesthetic is resolved before asking the Subject the numerical value that best describes her pain intensity.

At End-Of-Study visit (V4), patience tolerance and overall satisfaction with Vaginal Filler treatment will be assessed by means of 5-point Likert Scale. Only patients in the treatment group will be asked to fill out the Likert Scale, selecting a number from 1 to 5 that better corresponds to the degree of satisfaction about the treatment (0 - Not satisfied at all; 5 - Totally satisfied).

Safety data including examination of the vulva and vital signs of the patient will be collected at each visit.

During the screening phase (V-1), a gynecological examination will be performed to assess the presence of vulvar reddening, small fissures, fibrous whitish areas, ecchymosis and lacerations. Any abnormality identified at screening should be recorded on the General Medical History of CRF as Baseline Conditions. At subsequent visits (or as clinically indicated), limited, symptom-directed vulvar examinations should be performed. Changes from baseline abnormalities should be recorded in patient notes. New or worsened abnormalities after screening should be recorded as adverse events if appropriate.

Device deficiency/incident information will be collected by the investigator or its delegates on the CRF's.

Adverse event (AE) and adverse device effect information will be collected throughout the study. The event, date of onset, severity, duration, and relationship to the device will be recorded. Any AE will be monitored until it is adequately resolved or explained. All subjects will be also requested to report in a diary any adverse effect, in order to allow the Investigator to take the best decision to ensure the safety and well-being of trial subjects. During scheduled visits, patients will be properly interviewed by the medical staff to evaluate any adverse event. All AEs reported by the subject, observed by the Investigator, or documented in medical records will be recorded in the CRF, whether believed by the Investigator to be related or unrelated to the investigational device. Starting with the study enrollment, any new event/experience that was not present at baseline, or worsening of an event present at baseline, is considered an AE.

All concomitant medications should be registered by the investigator on the appropriate page in the electronic case report form (eCRF) with the dosage and the medication (active substance).

During the study, subjects will also be asked to record side effects and concomitant medications in a diary that will be dispensed at visit V0. At each scheduled visit, the investigator or delegates will properly interview the patients and check the diary to evaluate any concomitant medication.

Safety data including examination of the vulva and vital signs of the patient will be collected at each visit. Blood Pressure (systolic and diastolic pressures in mmHg) will be recorded for each patient using a sphygmomanometer.

Safety data including examination of the vulva and vital signs of the patient will be collected at each visit. Heart Rate (beats/min) will be recorded for each patient using a sphygmomanometer.