Vulvo Vaginal Atrophy
Conditions
Keywords
VVA, hyaluronic acid, vulvo vaginal atrophy, vaginal atrophy
Brief summary
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
Detailed description
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
Interventions
DEVICEproduct: Innea Aqua vaginal use
product object of the investigation: Innea Aqua for vaginal use, 2 mL product. Labelled as Innea Aqua.
DEVICEarm 2: standard of care
the comparator is the standard of care selected by the centre
Sponsors
Innate srl
CEBIS International
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
This is an open, double-arm, prospective, multicenter clinical investigation to evaluate the safety and efficacy of INNEA AQUA in adult women aged 18-75 with Vulvo-vaginal atrophy (VVA). The enrollment period will be 6 months, and the clinical investigation period will be up to 12 weeks per patient.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
Romania
Outcome results
None listed