Genitourinary Syndrome of Menopause
Conditions
Brief 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
Interventions
DEVICEHigh-concentration vaginal oxygen therapy (Caress Flow) with topical hyaluronic acid
five treatment sessions of high-concentration vaginal oxygen therapy (Caress Flow) with topical hyaluronic acid 2 weeks apart with a duration of approximately 15 minutes
DEVICEhyaluronic acid-based gel (Hydeal-D®)
hyaluronic acid-based gel (Hydeal-D®) applied once every three days for 12 weeks
Sponsors
Fondazione IRCCS Policlinico San Matteo di Pavia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| treatment compliance | one month | Comparison of the percentage of patients who, at the visit conducted one month after the completion of treatment, report not having followed the treatment |
Countries
Italy
Contacts
Primary ContactRossella Nappi, MD
Outcome results
None listed