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.