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

NCT06828640 | Recruiting

• 1 other identifier: B0762024240710
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

Brief 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)

Keywords

Vulvo vaginal atrophy; vaginal dilators; Genitourinary syndrome of menopause; treatment

Outcome Measures

Primary Outcomes (7)

• • 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 Outcomes (2)

• Number of participants with treatment-related adverse events

  At 4 and 12 weeks

• Rate of adherence to the study by patients

  At 4 and 12 weeks

Study Arms (2)

Test Group : vaginal dilators

EXPERIMENTAL

A Test group receiving the standard treatment + a kit of vaginal dilators with progressively larger sizes.

Device: vaginal dilators

Control Group : placebo

NO INTERVENTION

A control group receiving the standard treatment (which includes MHT, vaginal lubricants, and Moisturizers).

Interventions

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

Test Group : vaginal dilators

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Centre Hospitalier Universitaire Saint Pierre: lead

Study Sites (1)

Saint Pierre University Hospital Center

Brussels, Brussels Capital, 1000, Belgium

RECRUITING

Related Publications (1)

• 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 BACKGROUND

MeSH Terms

Conditions

Dyspareunia

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Genital Diseases, Male; Sexual Dysfunction, Physiological; Male Urogenital Diseases; Sexual Dysfunctions, Psychological; Mental Disorders

Study Officials

• Serge Rozenberg, Gynaecologist

  Saint Pierre University Hospital Center

  STUDY DIRECTOR

Central Study Contacts

Julie Piral, medical student

CONTACT

+33673428392; julie.piral@ulb.be

Aurélie Joris, gynaecologist

CONTACT

+32 2 535 34 86; aurelie.joris@stpierre-bru.be

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Monocentric pilot RCT evaluating SoC (MHT, lubricants, moisturizers) (control group) to SoC + vaginal dilators (test group). SoC = Standard of care RCT = randomized control trial MHT = Menopausal hormonal therapy

Study Record Dates

• First Submitted: February 4, 2025
• First Posted: February 14, 2025
• Study Start: October 16, 2024
• Primary Completion: October 1, 2025
• Study Completion: October 1, 2025
• Last Updated: February 14, 2025

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: October 2024 -2025 : 1 year
• Access Criteria: on request

Locations

BE (1)