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Concomitant Treatment with Topical Hyaluronic Acid and High Concentration Oxygen Therapy (Vaginal Natural Oxygenation Device - VNOD) in the Improvement of Symptoms Related to Genitourinary Syndrome of Menopause in Women with Natural and Oncological Postmenopause: Open-Label, Single-Center, Randomized Study (Caress)
The Caress study is a single-center, open-label, randomized controlled trial (RCT) evaluating the efficacy of a combined treatment using topical hyaluronic acid and high-concentration oxygen therapy (Vaginal Natural Oxygenation Device - VNOD) in improving symptoms of Genitourinary Syndrome of Menopause (GSM) in postmenopausal women, including those with a history of breast cancer. The primary objective is to assess vaginal dryness improvement one month after treatment, comparing two groups: an experimental group receiving VNOD therapy with hyaluronic acid and a control group using a hyaluronic acid-based gel (Hydeal-D®). Secondary endpoints include the evaluation of additional vaginal symptoms (pain, irritation, itching, sexual health, quality of life) up to six months post-treatment. The study will enroll 80 women (40 with a history of breast cancer and 40 without). Statistical analysis will use chi-square tests and logistic regression to compare symptom severity reduction between the two groups. With a duration of 18 months, the study aims to provide an innovative, non-hormonal treatment option to improve the quality of life for postmenopausal women, particularly those with a history of breast cancer
Details
| Lead sponsor | Fondazione IRCCS Policlinico San Matteo di Pavia |
|---|---|
| Phase | NA |
| Status | RECRUITING |
| Enrolment | 80 |
| Start date | 2023-10-16 |
| Completion | 2025-12 |
Conditions
- Genitourinary Syndrome of Menopause
Interventions
- High-concentration vaginal oxygen therapy (Caress Flow) with topical hyaluronic acid
- hyaluronic acid-based gel (Hydeal-D®)
Primary outcomes
- vaginal dryness one month after the completion of treatment — one month
comparison of the two treatment arms for the percentage of patients with a moderate or severe degree of vaginal dryness according to the Most Bothersome Symptoms - MBS scale (scores 2-3) one month after the end of treatment in the total enrolled women (Cohort 1 + Cohort 2).
Countries
Italy