Treatment of Vulvo-vaginal Atrophy (VVA) Using Vaginal Dilator in Addition to Usual Treatment

Centre Hospitalier Universitaire Saint Pierre

Status

Enrolling

Conditions

Vaginal Atrophy in Breast Cancer Patients

Treatment

Vulvo Vaginal Atrophy

Dyspareunia (Female)

Vaginal Atrophy Patients with GSM

Sexual Disfunction

Genitourinary Syndrome of Menopause (GSM)

Treatments

Device: vaginal dilators

Study type

Interventional

Funder types

Other

Identifiers

NCT06828640

B0762024240710

Details and patient eligibility

About

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

Enrollment

160 estimated patients

Sex

Female

Ages

18 to 85 years old

Volunteers

No Healthy Volunteers

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.