Actively Recruiting
Led by Centre Hospitalier Universitaire Saint Pierre · Updated on 2025-02-14
160
Participants Needed
1
Research Sites
N/A
Total Duration
Researchers are investigating the effectiveness of adding vaginal dilators to the usual treatment for vulvovaginal atrophy (VVA) in peri- and postmenopausal women, including breast cancer survivors. This randomized controlled trial compares standard care, which includes menopausal hormonal therapy (MHT), lubricants, and moisturizers, with the same care plus the use of vaginal dilators. The purpose is to assess whether vaginal dilators provide additional benefits for symptoms related to VVA and genitourinary syndrome of menopause. The trial randomly assigns participants to one of two groups: a control group receiving standard treatment and a test group receiving standard treatment plus a kit of silicone vaginal dilators of progressively larger sizes for gradual stretching. The study includes assessments at the start, 4 weeks, and 12 weeks to monitor changes over time. The vaginal dilator is used as a device intervention alongside existing treatments. Participants will undergo evaluations using several measures including vaginal dryness, vaginal and vulvar irritation or itching, pain during sexual intercourse, Vaginal Health Index Score, Female Sexual Function Index, and quality of life questionnaires specific to genitourinary syndrome. Patient satisfaction and adherence to treatment are also monitored. Safety is assessed by tracking treatment-related adverse events. The total participation duration covers 12 weeks, with assessments at multiple time points to understand the treatment's impact.
CONDITIONS
Treatment of Vulvo-vaginal Atrophy (VVA) Using Vaginal Dilator in Addition to Usual Treatment
You may qualify if you...
You will not qualify if you...
Complete this quick 3-step screening to check your eligibility
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 12 weeks
Participants receive vaginal dilators alongside their usual treatment as part of the study intervention.
Visits at baseline, Week 4, and Week 12
Total: 1 location
1
Saint Pierre University Hospital Center
Brussels, Brussels Capital, Belgium, 1000
Actively Recruiting
J
Julie Piral, medical student
A
Aurélie Joris, gynaecologist
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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Sheryl A Kingsberg, Susan Wysocki, Leslie Magnus...
https://pubmed.ncbi.nlm.nih.gov/23679050