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

Официальное название

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

Обзор

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

Вмешательства

• Устройство High-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
• Устройство hyaluronic acid-based gel (Hydeal-D®)
  hyaluronic acid-based gel (Hydeal-D®) applied once every three days for 12 weeks

Первичные конечные точки

• vaginal dryness one month after the completion of treatment [Срок оценки: one month]

Вторичные конечные точки (1)

• treatment compliance [Срок оценки: one month]

Критерии участия

Критерии включения

• 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).

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Италия · 1 центр

• Fondazione IRCCS Policlinico San Matteo, SSD Ostetricia e Ginecologia 2 - Riproduzione e P — Pavia

Идентификаторы

NCT: NCT06879938 · Caress

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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