The Effects of Local Vaginal Estrogen in Postmenopausal Women With Pelvic Organ Prolapse: A Randomized Control Trial
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 54
- 试验地点
- 1
- 主要终点
- Vaginal tissue samples obtained at the time of vaginal repair of pelvic organ prolapse will be analyzed for epithelial and subepithelial thickness, vascularity and inflammatory cells using standard H&E stains.
研究概览
简要总结
The purpose of this study is to find out how long it takes the vagina to respond to hormonal vaginal cream in women with pelvic organ prolapse (bulge in the vagina). It also will address the appropriate amount to use prior to vaginal repair of pelvic organ prolapse.
详细描述
Subjective and objective vaginal health symptoms, validated pelvic floor questionnaires, cytology and histology will be analyzed.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 45 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women aged 45 years or older
- •Postmenopausal (>55 if natural menopause)
- •Clinical atrophic vaginitis (at least mild atrophy)
- •Pelvic organ prolapse(at least stage 2 or greater)
- •Posthysterectomy
- •Surgery date between 2-12 weeks after recruitment
排除标准
- •Uterus present
- •Well-estrogenized appearing vagina
- •Known or suspected history of breast carcinoma
- •Hormone-dependent tumor
- •Genital bleeding of unknown cause
- •Acute thrombophlebitis or thromboembolic disorder associated with estrogen use
- •Vaginal infection requiring treatment
- •Allergy to estrogen or its constituents
- •Any serious disease or chronic condition that would interfere with study compliance or preoperative surgical clearance.
- •Use of exogenous corticosteroid or sex hormones (including homeopathic preparation) within the 8 weeks prior to recruitment
- •Initiation or continuation of anticholinergic medication (which could bias the results of the pelvic floor questionnaires)
研究组 & 干预措施
Premarin cream 0.5gm
Application of 0.5gm of vaginal estrogen cream nightly until surgery.
干预措施: Vaginal conjugated estrogen cream 0.5gm (Drug)
Premarin cream 1.0gm
Application of 1.0gm of vaginal estrogen cream nightly until surgery.
干预措施: Vaginal conjugated estrogen cream 1.0gm (Drug)
结局指标
主要结局
Vaginal tissue samples obtained at the time of vaginal repair of pelvic organ prolapse will be analyzed for epithelial and subepithelial thickness, vascularity and inflammatory cells using standard H&E stains.
时间窗: baseline and 2-12 weeks after treatment (at time of surgery)
次要结局
- Vaginal histology will be compared to validated pelvic floor quality of life questionnaires, vaginal health symptoms, vaginal health scoring, and vaginal cytology.(baseline and 2-12 weeks after treatment (at time of surgery))