NCT06828640

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

Treatment of Vulvo-vaginal Atrophy (VVA) Using Vaginal Dilator in Addition to Usual Treatment : a Randomized Control Trial

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 160 (estimated)
• Sponsor: Centre Hospitalier Universitaire Saint Pierre · Academic / Other
• Sex: Female
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

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)

Interventions

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

Timeline

• Start date: 2024-10-16
• Primary completion: 2025-10-01
• Completion: 2025-10-01
• First posted: 2025-02-14
• Last updated: 2025-02-14

Locations

1 site across 1 country: Belgium