This is a randomized, controlled trial aiming to evaluate the effectiveness of adding vaginal dilators to the treatment of vulvovaginal atrophy.
Study Population:
Peri- and postmenopausal women with VVA, including breast cancer survivors.
Design: Monocentric pilot RCT evaluating SoC (MHT, lubricants, moisturizers) (control group) to SoC + vaginal dilators (test group).
Vaginal Dilator : A silicone medical device will be used for gradual stretching progression. The kit includes dilators of progressively larger sizes.
Procedures: Assessments at baseline, at 4 \& 12 weeks
Measures : Vulvo Vaginal Atrophy severity , dyspareunia, Vaginal Health Index Score, Female Sexual Fonction Index, and Visual Analogue Scale (for vaginal dryness, vaginal and/or vulvar irritation/itching, and pain during sexual intercourse).
Statistical Analysis:
Differences at baseline, 4 weeks, and 12 weeks will be tested using:
Two-sample t-test Mann-Whitney test
Statistical Power:
Assuming a 20% improvement in Group 1 and 40% in Group 2, with:
p \< 0.05 (type I error) 80% power (type II error), 160 patients needed across both groups.
SoC = Standard of care RCT = Randimized control trial MHT = Menopausal hormonal therapy
Peri- or postmenopausal women suffering from vulvovaginal atrophy (VVA)
Breast cancer survivors with VVA symptoms
Understand the study, be willing to participate, and sign an informed consent form.
The use of estrogen/progestogen-based products (vaginal, oral, pellets, transdermal, etc.) is permitted but must be documented (this will be considered during randomization).
Undiagnosed abnormal genital bleeding.
Administration of any investigational drug within 30 days prior to the screening visit.
Presence of a serious medical condition, neurological disorder, or significant comorbidities.
Other gynecological malignancies.
Parallel
vaginal dilators
DeviceEvaluate the efficacy of vaginal dilators as an addition to Standard of Care in premenopausal or menopausal women, including breast cancer survivors
• Vaginal dryness score
* None: no feeling of dryness. * Mild: occasional feeling of dryness that does not interfere with daily activities. * Moderate: feeling dry most of the time but does not interfere with daily activities. * Severe: continuous feeling of dryness interfering with daily activities.
• Vaginal and/or vulvar irritation/itching
* None: no feeling of irritation. * Mild: occasional irritating sensation that does not interfere with daily activities. * Moderate: feeling irritated most of the time but does not interfere with daily activities. * Severe: continuous feeling of irritation interfering with daily activities.
• Pain during sexual intercourse score
* None: pleasant sexual intercourse, rare pain. * Mild: occasional pain, not during every sexual intercourse, intercourse should be interrupted occasionally. * Moderate: most of the time, little satisfaction during intercourse and it often has to be interrupted. * Severe: during each sexual intercourse, no pleasure during intercourse and these must often be interrupted. Often post-coital bleeding. Frequent abstinence due to pain.
Vaginal Health index score
The vaginal health score (VHIS) consists of analyzing five vaginal parameters: Vaginal elasticity; Volume of vaginal secretions; vaginal pH; the integrity of the epithelium of the vaginal walls and the lubrication/hydration of the vagina. For each vaginal parameter we give a score ranging from 1 to 5 The VHIS score is obtained by adding all the scores obtained (minimum score = 5 and maximum score = 25. If VHIS \<15, the vagina is considered atrophic.
Number of participants with treatment-related adverse events
Did you experience any side effects or discomfort related to the procedure? * Yes * No → If yes, can you specify which ones? 8. Have you considered stopping the procedure at any point? * Yes * No
Rate of adherence to the study by patients
Was the intervention compatible with your lifestyle? * Yes, absolutely * Rather yes * Rather no * No, not at all 10. Did you encounter any obstacles in following the intervention? * Yes * No → If yes, can you specify which ones?
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