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

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.