Atrophic Vulvovaginitis
Conditions
Brief summary
This randomized, controlled, prospective, multicenter study aims to evaluate the efficacy and safety of Lactobacillus crispatus M247 in combination with vaginal laser therapy for improving vaginal microbiota composition and reducing genitourinary symptoms in menopausal women with atrophic vulvovaginitis (VVA). Participants will be randomized into two groups: one receiving laser therapy alone and the other receiving laser therapy combined with daily administration of the probiotic Lactobacillus crispatus M247 (Crispact®). Primary outcomes include changes in genitourinary symptoms assessed using a validated vulvovaginal symptom questionnaire and evaluation of safety. Secondary outcomes include changes in vaginal microbiota composition.
Detailed description
Atrophic vulvovaginitis (VVA) is a common condition affecting menopausal women, characterized by symptoms such as vaginal dryness, dyspareunia, itching, and recurrent urinary tract infections. These symptoms result from decreased estrogen levels leading to an imbalance in vaginal microbiota. Standard treatments for VVA include hormonal therapy, but this approach is often associated with adverse effects and contraindications. This study investigates a non-hormonal approach using Lactobacillus crispatus M247 (Crispact®), a probiotic strain known for its ability to maintain a healthy vaginal microbiota, in combination with vaginal laser therapy. The study will include 75 menopausal women diagnosed with VVA who will be randomized in a 2:1 ratio, with a greater proportion allocated to the laser-only group and the remaining participants receiving laser therapy combined with the probiotic. Primary outcomes will include changes in genitourinary symptoms assessed using a validated vulvovaginal symptom questionnaire and evaluation of safety over the study period. Secondary outcomes will include changes in vaginal microbiota composition, including Lactobacillus crispatus levels, assessed at baseline (T0) and three months (T3). The study is approved by the Ethics Committee for Human Experimentation (CESU), University of Urbino Carlo Bo, under protocol 124\_6March2025\_Lactobacillus crispatus M247\_Sisti, on 29.04.2025.
Interventions
DEVICEMonnalisa Touch® Laser Therapy
Monnalisa Touch® laser therapy is a non-ablative fractional CO2 laser applied to the vaginal mucosa to promote tissue regeneration and maintain vaginal health. Participants in this group will receive three sessions of laser therapy, one session every 30 days.
COMBINATION_PRODUCTMonnalisa Touch® Laser Therapy + Lactobacillus crispatus M247 (Crispact®)
Participants in this group will receive three sessions of Monnalisa Touch® laser therapy, one session every 30 days, along with daily administration of Lactobacillus crispatus M247 (Crispact®), a probiotic containing 20 billion CFU, taken orally for three months.
Sponsors
Università degli Studi dell'Insubria
Liaquat University of Medical & Health Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Participants will be randomized to one of two groups in a 2:1 (Laser-only : Laser + Crispact) Group 1: Vaginal laser therapy only. Group 2: Vaginal laser therapy + Lactobacillus crispatus M247 (Crispact®) probiotic.
Eligibility
Sex/Gender
FEMALE
Age
40 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Menopausal women with no menstrual cycle for \>12 months. * Diagnosed with atrophic vulvovaginitis (VVA) and experiencing related symptoms (vaginal dryness, introital and profound dyspareunia, itching, burning, bleeding during intercourse). * Symptoms related to genitourinary syndrome of menopause (GSM), including urinary urgency, increased frequency, nocturia, recurrent cystitis, or post-coital cystitis. * Prior negative PAP test performed within one year of enrollment. * Women who are unresponsive to or dissatisfied with prior topical estrogen therapy or who have contraindications to local and/or systemic estrogen prescription.
Exclusion criteria
* Pregnancy or breastfeeding. * Presence of preneoplastic or neoplastic lesions of the cervix, vagina, or vulva. * Active genital and/or urinary tract infections. * Dermatological contraindications to laser therapy. * Ongoing systemic or local hormone therapy. * Neurological or psychiatric disorders. * Chronic systemic diseases of autoimmune or dysmetabolic nature.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Genitourinary Symptoms | Baseline (T0) to Month 3 (M3). | Assessment using the Vulvovaginal Atrophy Symptom Questionnaire (VASQ), evaluating symptom severity (e.g., vaginal dryness, itching, dyspareunia, urinary symptoms) from baseline (T0) to Month 3 (M3). |
| Safety Assessment | Baseline (T0) to Month 3 (M3). | Evaluation of safety and tolerability of Lactobacillus crispatus M247 based on the incidence of adverse events throughout the study period (Baseline to Month 3). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Vaginal Microbiota Composition (Lactobacillus crispatus Abundance) | Baseline (T0) and 3 months (T3). | Assessment of the change in the abundance of Lactobacillus crispatus in the vaginal microbiota, measured using vaginal swab samples analyzed at baseline (T0) and after 3 months (T3). |
Countries
Italy
Outcome results
None listed