Vestibulectomy: A Prospective Comparison of Two Surgical Techniques for the Treatment of Provoked Localized Vulvodynia (PVD)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 118
- 试验地点
- 2
- 主要终点
- Change in Tampon Test pain scores from baseline to 3 months
研究概览
简要总结
Vestibulectomy Surgical Techniques Comparison Study
详细描述
Vestibulectomy: A Prospective Comparison of Two Surgical Techniques for the treatment of Provoked Localized Vulvodynia (PVD)
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 80 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Reported provoked tenderness to the vestibule for at least 3 months in non-pregnant, estrogen-replete healthy subjects aged 18 years or over meeting Friedrich's criteria for PVD44-45 and supported by the ISSVD Terminology Consensus Definition45 for vulvar pain. Subjects who are >45years of age must have either have a maturation index52 of < 10% parabasal cells or willingness to participate in local estrogen replacement until achieving this same clinical result.
- •Cotton swab Test30-31 mean verbal rating score of ≥4/10 in 4 of 6 defined points of the vestibule (2, 4, 6, 8, 10, 12 o'clock) and cotton swab test verbal score ≤ 2/10 for the labia majora and minora, intra labial sulcus, and perineum
- •Ability to insert a regular Tampax® tampon
- •Baseline Tampon Test verbal pain score ≥430
- •f. Phone and internet access e. Willingness to engage in pelvic floor physical therapy (PT)
排除标准
- •Any other clinical reason for dyspareunia (endometriosis pain, chronic pelvic pain, vulvar dermatoses such as psoriasis, lichen sclerosus)
- •Unable or unwilling to complete baseline assessments
- •Prior vestibulectomy or hymen surgery
- •Prior or current use of testosterone dosed for gender affirmation
结局指标
主要结局
Change in Tampon Test pain scores from baseline to 3 months
时间窗: Baseline visit to 3 months after surgery
The change from baseline in pain measured by the Tampon Test at 3 months after surgery. The tampon test is a validated tool used to measure (vulva) vestibular skin pain by having participants insert and remove a tampon. Participants will be asked to rate their pain along a 100 mm Visual Analog Scale on a scale of 0 (No pain) to 10 (Pain as bad as you can imagine). This test will occur at baseline and 3 months follow up.
Change in pain scores from baseline to 6 months
时间窗: Baseline visit to 6 months after surgery
The change from baseline in pain measured by the Tampon Test at 6 months after surgery. The tampon test is a validated tool used to measure (vulva) vestibular skin pain by having participants insert and remove a tampon. Participants will be asked to rate their pain along a 100 mm Visual Analog Scale on a scale of 0 (No pain) to 10 (Pain as bad as you can imagine). This test will occur at baseline and 6 months follow up.
Change in pain scores from baseline to 12 months
时间窗: Baseline visit to 12 months after surgery
The change from baseline in pain measured by the Tampon Test at 12 months after surgery. The tampon test is a validated tool used to measure (vulva) vestibular skin pain by having participants insert and remove a tampon. Participants will be asked to rate their pain along a 100 mm Visual Analog Scale on a scale of 0 (No pain) to 10 (Pain as bad as you can imagine). This test will occur at baseline and 12 months follow up.
次要结局
未报告次要终点
研究者
Catherine M Leclair, MD
Professor
Oregon Health and Science University