Clinical Investigation to Assess Safety and Efficacy of INNEA AQUA in Adult Women With Vulvo-Vaginal Atrophy (VVA)

Clinical investigation to assess safety and efficacy of INNEA AQUA in adult women with Vulvo-Vaginal Atrophy (VVA).

To assess the Safety and efficacy of INNEA AQUA

• product: Innea Aqua vaginal use (Device): product object of the investigation: Innea Aqua for vaginal use, 2 mL product. Labelled as Innea Aqua.
• arm 2: standard of care (Device): the comparator is the standard of care selected by the centre

Primary outcomes

• safety: Incidence of AE and SAE [From enrollment to the end of treatment and second follow up visit at 120 days from the first injection]: To evaluate the safety of INNEA AQUA in adult participants. Incidence of adverse events, early withdrawal rate due to AEs, and device deficiencies, whether serious or not

Secondary outcomes

• Efficacy: change in pruritus [From enrollment to the end of treatment and second follow up visit at 120 days from the first injection]: Change in Pruritus (0-10 visual analogue scales (VAS)) on Day 0, Day 30, Day 51, and Day 120
• Efficacy: Change in soreness [From enrollment to the end of treatment and second follow up visit at 120 days from the first injection]: Change in Soreness (0-10 visual analogue scales (VAS)) on Day 0, Day 30, Day 51, and Day 120
• Efficacy: change in dyspareunia [From enrollment to the end of treatment and second follow up visit at 120 days from the first injection]: Change in Dyspareunia (0-10 visual analogue scales (VAS)) on Day 0, Day 30, Day 51, and Day 120
• efficacy: change in irritation [From enrollment to the end of treatment and second follow up visit at 120 days from the first injection]: Change in Irritation (0-10 visual analogue scales (VAS)) on Day 0, Day 30, Day 51, and Day 120
• efficacy: evaluation of pH [From enrollment to the end of treatment and second follow up visit at 120 days from the first injection]: Vaginal Ph Normalization
• efficacy: change in vaginal moisture [From enrollment to the end of treatment and second follow up visit at 120 days from the first injection]: Change in Vaginal moisture - Modified Schirmer test (mm) change on Day 30, Day 51, and Day 120 compared with baseline
• efficacy: change in VHX [From enrollment to the end of treatment and second follow up visit at 120 days from the first injection]: Change in Vaginal Health Index (VHI) score on Day 30, Day 51, and Day 120
• efficacy: evaluation of vaginal aging [From enrollment to the end of treatment and second follow up visit at 120 days from the first injection]: Change in Day-to-Day Impact of Vaginal Aging Questionnaire on Day 30, Day 51, and Day 120
• safety (AE/SAE) [From enrollment to the end of treatment and second follow up visit at 120 days from the first injection]: Incidence of adverse events, early withdrawal rate due to AEs, and device deficiencies, whether serious or not
• efficacy: satisfaction of the patient [From enrollment to the end of treatment and second follow up visit at 120 days from the first injection]: Participant satisfaction in using the Device (PGI-I) Day 120
• efficacy: satisfaction of the investigator [From enrollment to the end of treatment and second follow up visit at 120 days from the first injection]: Investigator satisfaction in using the Device (VAS) Day 120
• efficacy: evaluation of quality of life [From enrollment to the end of treatment and second follow up visit at 120 days from the first injection]: Change in baseline score in QoL score when compared to Day 30, 51 and 120.

Sex: Female, ages: 18 Years to 75 Years

Inclusion Criteria:

* Adult women aged 18-75 (both fertile and post-menopausal)
* Vulvovaginal atrophy diagnostic
* Signed written informed consent.
* Vaginal Ph more than 4.5
* Willing to sign the informed consent form
* Willing to comply with the clinical investigation visits.

Exclusion Criteria:

* patients who tend to develop hypertrophic scarring,
* patients with a history of autoimmune disease or who are receiving immune therapy,
* patients who are known to be hypersensitive or allergic to hyaluronic acid and other INNEA AQUA components,
* pregnant or breastfeeding women,
* patients under 18 years of age,
* vagina with hypertrophic scars from different etiology,
* patients with presence of ≥ stage 2 apical pelvic organ prolapse,
* patients with stress urinary incontinence,
* patients with vaginismus, vulvovaginal or urinary tract infection,
* patients with Hemorrhagic or neoplastic genital pathologies or hormone-dependent tumor
* patients with genital bleeding of unknown etiology, recurrent porphyria, uncontrolled epilepsy, heart conduction disorders, recurrent angina, rheumatic fever, previous vulvovaginal or uro-gynecological surgery, and hemostatic disorders,
* Anticoagulated patients or patients receiving platelet aggregation inhibitors should not be treated with INNEA AQUA,
* INNEA AQUA must not be used in areas presenting inflammatory and/or infectious processes (e.g., papilloma, herpes). INNEA AQUA must not be used in association with other invasive treatments,
* Avoid using in combination with any other concomitant therapies for same indication;
* Patients who are using substances that can prolong bleeding (such as aspirin, nonsteroidal anti-inflammatory drugs, and warfarin) may, as with any injection, experience increased bruising or bleeding at treatment sites.