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NCT Number: NCT06828640

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

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

Recruiting

Interested in participating?

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Key information

Conditions

Vulvo Vaginal Atrophy Dyspareunia Dyspareunia (Female) Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Diseases, Male Genitourinary Syndrome of Menopause (GSM) Male Urogenital Diseases Mental Disorders Sexual Disfunction Sexual Dysfunction, Physiological Sexual Dysfunctions, Psychological Treatment Urogenital Diseases Vaginal Atrophy Patients With GSM Vaginal Atrophy in Breast Cancer Patients

Age range

18 year–85 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Saint Pierre University Hospital Center

Brussels, Brussels Capital, 1000, Belgium

Location status: Recruiting

Location contact

Aurélie Joris, Gynaecologist

CONTACT

[email protected]

+32 2 535 3486

Julie Piral, medical student

CONTACT

[email protected]

+33673428392

Julie Piral, medical student

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

vaginal dilators

Device

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

Primary outcomes

  1. • Vaginal dryness score

    Time frame: At baseline, 4 and 12 weeks

    • None: no feeling of dryness.
    • Mild: occasional feeling of dryness that does not interfere with daily activities.
    • Moderate: feeling dry most of the time but does not interfere with daily activities.
    • Severe: continuous feeling of dryness interfering with daily activities.

  2. • Vaginal and/or vulvar irritation/itching

    Time frame: At baseline, 4 and 12 weeks

    • None: no feeling of irritation.
    • Mild: occasional irritating sensation that does not interfere with daily activities.
    • Moderate: feeling irritated most of the time but does not interfere with daily activities.
    • Severe: continuous feeling of irritation interfering with daily activities.

  3. • Pain during sexual intercourse score

    Time frame: At baseline, 4 and 12 weeks

    • None: pleasant sexual intercourse, rare pain.
    • Mild: occasional pain, not during every sexual intercourse, intercourse should be interrupted occasionally.
    • Moderate: most of the time, little satisfaction during intercourse and it often has to be interrupted.
    • Severe: during each sexual intercourse, no pleasure during intercourse and these must often be interrupted. Often post-coital bleeding. Frequent abstinence due to pain.

  4. Vaginal Health index score

    Time frame: at baseline and 12 weeks

    The vaginal health score (VHIS) consists of analyzing five vaginal parameters: Vaginal elasticity; Volume of vaginal secretions; vaginal pH; the integrity of the epithelium of the vaginal walls and the lubrication/hydration of the vagina.

    For each vaginal parameter we give a score ranging from 1 to 5 The VHIS score is obtained by adding all the scores obtained (minimum score = 5 and maximum score = 25.

    If VHIS <15, the vagina is considered atrophic.

  5. Patient satisfaction : visual analogue scale

    Time frame: At baseline, 4 and 12 weeks

    Evaluation of symptoms linked to vaginal atrophy (dryness, irritation, dyspareunia) on a visual analogue scale for pain (0 to 10) 0 = symptoms absent 10 = unbearable symptoms

  6. Quality of life questionnaire specific to genitourinary syndrome

    Time frame: At baseline, 4 and 12 weeks

    Answer yes or no :

    Over the past week, have you been bothered by:

    Itchy vulva? Burning or tingling in the vulva? Pain in the vulva? Irritations to the vulva? Dryness in the vulva? Unpleasant vulvar or vaginal discharge? Odors coming from your vulva or vagina? Are you worried about your vulvar symptoms? (for example, will it spread, get worse, leave scars? etc.) Frustrations about your vulvar symptoms? Embarrassment about your vulvar symptoms? How do your vulvar symptoms affect your interactions with others? How do your vulvar symptoms affect your desire to be with people? Do your vulvar symptoms prevent you from showing affection? How do your vulvar symptoms affect your daily activities? Do your vulvar symptoms prevent you from having intimate relationships? The effects of your vulvar symptoms on your sexual relations? Do your vulvar symptoms cause pain during sexual activity? Do your vulvar symptoms cause dryness during sexual activity?

  7. Female Sexual Function Index (FSFI) questionnaire

    Time frame: At baseline, 4 and 12 weeks

    • Desire Question :1, 2 Score range (1 - 5 ) min score 1.2 max score 6.0
    • Arousal Question : 3, 4, 5, 6 Score range( 0 - 5) min score : 0 Max score : 6.0
    • Lubrication: Question 7, 8, 9, 10 Score range(0 - 5) min score : 0 max score : 6.0
    • Orgasm : Question 11, 12, 13 Score range (0 - 5) min score 0 max score : 6.0
    • Satisfaction: Question : 14, 15, 16 Score range (0 (or 1) - 5) min score : 0.8 max score : 6.0
    • Pain : Question : 17, 18, 19 Score range(0 - 5) min score : 0 max score : 6.0

    Full Scale Score Range minimum score : 2.0 maximum score : 36.0

Secondary outcomes

  1. Number of participants with treatment-related adverse events

    Time frame: At 4 and 12 weeks

    Did you experience any side effects or discomfort related to the procedure?

    • Yes
    • No

    → If yes, can you specify which ones? 8. Have you considered stopping the procedure at any point?

    • Yes
    • No

  2. Rate of adherence to the study by patients

    Time frame: At 4 and 12 weeks

    Was the intervention compatible with your lifestyle?

    • Yes, absolutely
    • Rather yes
    • Rather no
    • No, not at all 10. Did you encounter any obstacles in following the intervention?
    • Yes
    • No → If yes, can you specify which ones?

Study contacts

Contact information is provided by the study sponsor or research team.

Aurélie Joris, gynaecologist

CONTACT

[email protected]

+32 2 535 34 86

Julie Piral, medical student

CONTACT

[email protected]

+33673428392

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire Saint Pierre

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Feb 14, 2025
Registry last updated
Feb 14, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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