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

NCT06828640 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 160

Last updated 2025-02-14

No results posted yet for this 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

Conditions

  • Vulvo Vaginal Atrophy
  • Genitourinary Syndrome of Menopause (GSM)
  • Vaginal Atrophy in Breast Cancer Patients
  • Vaginal Atrophy Patients With GSM
  • Treatment
  • Sexual Disfunction
  • Dyspareunia (Female)

Interventions

DEVICE

vaginal dilators

Evaluate the efficacy of vaginal dilators as an addition to Standard of Care in premenopausal or menopausal women, including breast cancer survivors

Sponsors & Collaborators

  • Centre Hospitalier Universitaire Saint Pierre

    lead OTHER

Principal Investigators

  • Serge Rozenberg, Gynaecologist · Saint Pierre University Hospital Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-10-16
Primary Completion
2025-10-31
Completion
2025-10-31

Countries

  • Belgium

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06828640 on ClinicalTrials.gov