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

ConditionGenitourinary Syndrome of Menopause

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexFemale

Age18+

SponsorFondazione IRCCS Policlinico San Matteo di Pavia

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

Informed consent signature

Willingness to undergo treatment and follow-up evaluations according to the schedule outlined in the protocol

Age > 18 years

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.

Disqualifiers

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;

Trial design

Design model

Parallel

Treatments tested in this trial

High-concentration vaginal oxygen therapy (Caress Flow) with topical hyaluronic acid
Device
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
hyaluronic acid-based gel (Hydeal-D®)
Device
hyaluronic acid-based gel (Hydeal-D®) applied once every three days for 12 weeks

Treatment groups

80 Participants

are divided into 2 treatment groups

Group A: High-concentration vaginal oxygen therapy (Caress Flow) with topical hyaluronic acidExperimental treatment 1 intervention

Group B: Hyaluronic acid-based gel (Hydeal-D®) applied once every three daysActive comparator 1 intervention

Trial outcomes

Primary outcomes

vaginal dryness one month after the completion of treatment

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).

Time frame

one month

Secondary outcomes

treatment compliance

Comparison of the percentage of patients who, at the visit conducted one month after the completion of treatment, report not having followed the treatment

Time frame

one month

Sponsors and contacts

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Fondazione IRCCS Policlinico San Matteo di Pavia

Lead sponsor

Source ClinicalTrials.gov

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