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Recruiting NCT06828640

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

No phase Interventional Vulvo Vaginal Atrophy Genitourinary Syndrome of Menopause (GSM) Vaginal Atrophy in Breast Cancer Patients Vaginal Atrophy Patients With GSM

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: vaginal dilators.
Who it may be relevant to
Registry conditions: Vulvo Vaginal Atrophy, Genitourinary Syndrome of Menopause (GSM), Vaginal Atrophy in Breast Cancer Patients, Vaginal Atrophy Patients With GSM. Basic parameters: 18 years — 85 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Belgium
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Treatment of Vulvo-vaginal Atrophy (VVA) Using Vaginal Dilator in Addition to Usual Treatment : a Randomized Control Trial

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

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

Primary outcome measures

  • • Vaginal dryness score [Time frame: At baseline, 4 and 12 weeks]
  • • Vaginal and/or vulvar irritation/itching [Time frame: At baseline, 4 and 12 weeks]
  • • Pain during sexual intercourse score [Time frame: At baseline, 4 and 12 weeks]
  • Vaginal Health index score [Time frame: at baseline and 12 weeks]
  • Patient satisfaction : visual analogue scale [Time frame: At baseline, 4 and 12 weeks]
  • Quality of life questionnaire specific to genitourinary syndrome [Time frame: At baseline, 4 and 12 weeks]
  • Female Sexual Function Index (FSFI) questionnaire [Time frame: At baseline, 4 and 12 weeks]
Secondary outcome measures (2)
  • Number of participants with treatment-related adverse events [Time frame: At 4 and 12 weeks]
  • Rate of adherence to the study by patients [Time frame: At 4 and 12 weeks]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

Belgium · 1 center
  • Saint Pierre University Hospital Center — Brussels

Publications

  • Kingsberg SA, Wysocki S, Magnus L, Krychman ML. Vulvar and vaginal atrophy in postmenopausal women: findings from the REVIVE (REal Women's VIews of Treatment Options for Menopausal Vaginal ChangEs) survey. J Sex Med. 2013 Jul;10(7):1790-9. doi: 10.1111/jsm.12190. Epub 2013 May 16. PMID 23679050

Identifiers

NCT: NCT06828640 · B0762024240710

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗