Treatment of Vulvo-vaginal Atrophy (VVA) Using Vaginal Dilator in Addition to Usual Treatment
Trial Parameters
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Brief Summary
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
Eligibility Criteria
Inclusion Criteria: * 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). Exclusion Criteria: * 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. * Recent vaginal surgery. * Clinically significant prolapse (POP-Q ≤ 2). * Current urinary tract or vaginal infection, or recent sexually transmitted infection. * Individuals with disabilities unable to communicate. * Women eligible for the study but unwilling to participate.