Clinical trial NCT06828640: Treatment of Vulvo-vaginal Atrophy (VVA) Using Vaginal Dilator in Addition to Usual Treatment
Official title: Treatment of Vulvo-vaginal Atrophy (VVA) Using Vaginal Dilator in Addition to Usual Treatment : a Randomized Control Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
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
Lead sponsor: Centre Hospitalier Universitaire Saint Pierre
Sponsor class: OTHER
First posted: 2025-02-14
Enrollment: 160
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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
Primary purpose: TREATMENT

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


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.

Primary outcomes:
measure: • Vaginal dryness score
timeFrame: At baseline, 4 and 12 weeks
measure: • Vaginal and/or vulvar irritation/itching
timeFrame: At baseline, 4 and 12 weeks
measure: • Pain during sexual intercourse score
timeFrame: At baseline, 4 and 12 weeks
measure: Vaginal Health index score
timeFrame: at baseline and 12 weeks
measure: Patient satisfaction : visual analogue scale
timeFrame: At baseline, 4 and 12 weeks
measure: Quality of life questionnaire specific to genitourinary syndrome
timeFrame: At baseline, 4 and 12 weeks
measure: Female Sexual Function Index (FSFI) questionnaire
timeFrame: At baseline, 4 and 12 weeks
Secondary outcomes:
measure: Number of participants with treatment-related adverse events
timeFrame: At 4 and 12 weeks
measure: Rate of adherence to the study by patients
timeFrame: At 4 and 12 weeks
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: Saint Pierre University Hospital Center
Study officials:
affiliation: Saint Pierre University Hospital Center
name: Serge Rozenberg, Gynaecologist
role: STUDY_DIRECTOR
References:
citation: 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.