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

Last updated: February 11, 2025
Sponsor: Centre Hospitalier Universitaire Saint Pierre
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

vaginal dilators

Clinical Study ID

NCT06828640
B0762024240710
  • Ages 18-85
  • Female

Study 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

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 duringrandomization).

Exclusion

Exclusion Criteria:

  • Undiagnosed abnormal genital bleeding.

  • Administration of any investigational drug within 30 days prior to the screeningvisit.

  • Presence of a serious medical condition, neurological disorder, or significantcomorbidities.

  • Other gynecological malignancies.

  • Recent vaginal surgery.

  • Clinically significant prolapse (POP-Q ≤ 2).

  • Current urinary tract or vaginal infection, or recent sexually transmittedinfection.

  • Individuals with disabilities unable to communicate.

  • Women eligible for the study but unwilling to participate.

Study Design

Total Participants: 160
Treatment Group(s): 1
Primary Treatment: vaginal dilators
Phase:
Study Start date:
October 16, 2024
Estimated Completion Date:
October 31, 2025

Connect with a study center

  • Saint Pierre University Hospital Center

    Brussels, 1000
    Belgium

    Active - Recruiting

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