Overview

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

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.