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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

160 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-10-16

Study Completion Date

2025-10-31

Brief Summary

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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

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Detailed Description

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Conditions

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Vulvo Vaginal Atrophy Genitourinary Syndrome of Menopause (GSM) Vaginal Atrophy in Breast Cancer Patients Vaginal Atrophy Patients With GSM Treatment Sexual Disfunction Dyspareunia (Female)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Test Group : vaginal dilators

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

Group Type EXPERIMENTAL

vaginal dilators

Intervention Type DEVICE

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

Control Group : placebo

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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vaginal dilators

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

Intervention Type DEVICE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No