Treatment of Vulvo-vaginal Atrophy (VVA) Using Vaginal Dilator in Addition to Usual Treatment : a Randomized Control Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 160
- 试验地点
- 2
- 主要终点
- • Vaginal dryness score
研究概览
简要总结
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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).
排除标准
- •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.
结局指标
主要结局
• Vaginal dryness score
时间窗: At baseline, 4 and 12 weeks
* None: no feeling of dryness. * Mild: occasional feeling of dryness that does not interfere with daily activities. * Moderate: feeling dry most of the time but does not interfere with daily activities. * Severe: continuous feeling of dryness interfering with daily activities.
• Vaginal and/or vulvar irritation/itching
时间窗: At baseline, 4 and 12 weeks
* None: no feeling of irritation. * Mild: occasional irritating sensation that does not interfere with daily activities. * Moderate: feeling irritated most of the time but does not interfere with daily activities. * Severe: continuous feeling of irritation interfering with daily activities.
• Pain during sexual intercourse score
时间窗: At baseline, 4 and 12 weeks
* None: pleasant sexual intercourse, rare pain. * Mild: occasional pain, not during every sexual intercourse, intercourse should be interrupted occasionally. * Moderate: most of the time, little satisfaction during intercourse and it often has to be interrupted. * Severe: during each sexual intercourse, no pleasure during intercourse and these must often be interrupted. Often post-coital bleeding. Frequent abstinence due to pain.
Vaginal Health index score
时间窗: at baseline and 12 weeks
The vaginal health score (VHIS) consists of analyzing five vaginal parameters: Vaginal elasticity; Volume of vaginal secretions; vaginal pH; the integrity of the epithelium of the vaginal walls and the lubrication/hydration of the vagina. For each vaginal parameter we give a score ranging from 1 to 5 The VHIS score is obtained by adding all the scores obtained (minimum score = 5 and maximum score = 25. If VHIS \<15, the vagina is considered atrophic.
Patient satisfaction : visual analogue scale
时间窗: At baseline, 4 and 12 weeks
Evaluation of symptoms linked to vaginal atrophy (dryness, irritation, dyspareunia) on a visual analogue scale for pain (0 to 10) 0 = symptoms absent 10 = unbearable symptoms
Quality of life questionnaire specific to genitourinary syndrome
时间窗: At baseline, 4 and 12 weeks
Answer yes or no : Over the past week, have you been bothered by: Itchy vulva? Burning or tingling in the vulva? Pain in the vulva? Irritations to the vulva? Dryness in the vulva? Unpleasant vulvar or vaginal discharge? Odors coming from your vulva or vagina? Are you worried about your vulvar symptoms? (for example, will it spread, get worse, leave scars? etc.) Frustrations about your vulvar symptoms? Embarrassment about your vulvar symptoms? How do your vulvar symptoms affect your interactions with others? How do your vulvar symptoms affect your desire to be with people? Do your vulvar symptoms prevent you from showing affection? How do your vulvar symptoms affect your daily activities? Do your vulvar symptoms prevent you from having intimate relationships? The effects of your vulvar symptoms on your sexual relations? Do your vulvar symptoms cause pain during sexual activity? Do your vulvar symptoms cause dryness during sexual activity?
Female Sexual Function Index (FSFI) questionnaire
时间窗: At baseline, 4 and 12 weeks
* Desire Question :1, 2 Score range (1 - 5 ) min score 1.2 max score 6.0 * Arousal Question : 3, 4, 5, 6 Score range( 0 - 5) min score : 0 Max score : 6.0 * Lubrication: Question 7, 8, 9, 10 Score range(0 - 5) min score : 0 max score : 6.0 * Orgasm : Question 11, 12, 13 Score range (0 - 5) min score 0 max score : 6.0 * Satisfaction: Question : 14, 15, 16 Score range (0 (or 1) - 5) min score : 0.8 max score : 6.0 * Pain : Question : 17, 18, 19 Score range(0 - 5) min score : 0 max score : 6.0 Full Scale Score Range minimum score : 2.0 maximum score : 36.0
次要结局
- Number of participants with treatment-related adverse events(At 4 and 12 weeks)
- Rate of adherence to the study by patients(At 4 and 12 weeks)