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, randomize

Conditions: Genitourinary Syndrome of Menopause

Summary: 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


Eligibility criteria:
inclusion criteria: * informed consent signature * willingness to undergo treatment and follow-up evaluations according to the schedule outlined in the protocol * age \> 18 years cohort 1: * diagnosis of non-metastatic breast cancer (m0/mx according to tnm system) who have undergone surgical and/or chemotherapy and/or immunotherapy and/or radiotherapy and/or endocrine treatment. * postmenopausal women (fsh \> 30 uiiu/l, e2 \< 20 pg/ml), either naturally or surgically induced, or iatrogenic post-chemotherapy with absent menstrual cycle for at least 6 months; or premenopausal women on treatment with lhrh analog +/- tamoxifen and/or aromatase inhibitor for at least 6 months. * at least a score of 2 (moderate) for vaginal dryness associated with vulvovaginal atrophy (score 2-3 on the mbs scale). * signs of pelvic static alterations not exceeding pop-q score 2 (pop-q). cohort 2: * postmenopausal women (fsh \> 30 ui/l, e2 \< 20 pg/ml), with absent menstrual cycle for at least 6 months, or women who have undergone bilateral adnexectomy at least 6 months ago. * at least a score of 2 (moderate) for vaginal dryness associated with vulvovaginal atrophy (score 2-3 on the mbs scale). * signs of pelvic static alterations not exceeding pop-q score 2 (pop-q). exclusion criteria: * other current therapy aimed at resolving symptoms associated with vulvo-vaginal atrophy, with the exception of the use of lubricants if sexual activity is present; * hrt in progress or discontinued for less than 6 months; * ongoing vulvo-vaginal and urinary infections; * bleeding of ndd; * pathological pap-test within the previous 12 months.