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

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

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

Study Overview

• Status: Recruiting
• Conditions: Treatment; Vulvo Vaginal Atrophy; Dyspareunia (Female); Genitourinary Syndrome of Menopause (GSM); Vaginal Atrophy in Breast Cancer Patients; Sexual Disfunction; Vaginal Atrophy Patients with GSM
• Intervention / Treatment: Device: vaginal dilators

• Study Type: Interventional
• Enrollment (Estimated): 160
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Julie Piral, medical student; Phone Number: +33673428392; Email: julie.piral@ulb.be
• Study Contact Backup: Name: Aurélie Joris, gynaecologist; Phone Number: +32 2 535 34 86; Email: aurelie.joris@stpierre-bru.be

Study Locations

• Belgium
  • Brussels, Belgium, 1000
    • Recruiting
    • Saint Pierre University Hospital Center
    • Contact: Julie Piral, medical student; Phone Number: +33673428392; Email: julie.piral@ulb.be
    • Contact: Aurélie Joris, Gynaecologist; Phone Number: +32 2 535 3486; Email: aurelie.joris@stpierre-bru.be
    • Contact: Julie Piral, medical student

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Test Group : vaginal dilators; A Test group receiving the standard treatment + a kit of vaginal dilators with progressively larger sizes.	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
No Intervention: Control Group : placebo; A control group receiving the standard treatment (which includes MHT, vaginal lubricants, and Moisturizers).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
• Vaginal dryness score	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.	At baseline, 4 and 12 weeks
• Vaginal and/or vulvar irritation/itching	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.	At baseline, 4 and 12 weeks
• Pain during sexual intercourse score	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.	At baseline, 4 and 12 weeks
Vaginal Health index score	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.	at baseline and 12 weeks
Patient satisfaction : visual analogue scale	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	At baseline, 4 and 12 weeks
Quality of life questionnaire specific to genitourinary syndrome	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?	At baseline, 4 and 12 weeks
Female Sexual Function Index (FSFI) questionnaire	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	At baseline, 4 and 12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of participants with treatment-related adverse events	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	At 4 and 12 weeks
Rate of adherence to the study by patients	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?	At 4 and 12 weeks

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire Saint Pierre
• Investigators: Study Director: Serge Rozenberg, Gynaecologist, Saint Pierre University Hospital Center

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (Actual): October 16, 2024
• Primary Completion (Estimated): October 1, 2025
• Study Completion (Estimated): October 1, 2025

Study Registration Dates

• First Submitted: February 4, 2025
• First Submitted That Met QC Criteria: February 11, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 11, 2025
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Keywords: treatment; Vulvo vaginal atrophy; Genitourinary syndrome of menopause; vaginal dilators
• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Mental Disorders; Genital Diseases, Male; Male Urogenital Diseases; Pathological Conditions, Anatomical; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Genital Diseases, Female; Sexual Dysfunction, Physiological; Sexual Dysfunctions, Psychological; Atrophy; Dyspareunia
• Other Study ID Numbers: B0762024240710

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: all collected IPD, all IPD that underlie results in a publication
• IPD Sharing Time Frame: October 2024 -2025 : 1 year
• IPD Sharing Access Criteria: on request
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No