Role of Hormonal Status on Vascularization and Vaginal Tissue in Women With Pelvic Organ Prolapse
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 7
- 试验地点
- 1
- 主要终点
- Vaginal Epithelial Thickness
研究概览
简要总结
Our primary aim in the current study is to determine important tissue differences, including muscle and connective tissue changes, between postmenopausal women and reproductive age women with pelvic floor dysfunction to help develop targeted and noninvasive treatments.
详细描述
Our primary aim in the current study is to determine important tissue differences, including muscle and connective tissue changes, between postmenopausal women and reproductive age women with pelvic floor dysfunction to help develop targeted and noninvasive treatments. We will perform in vivo evaluations with colposcopy and OCT to determine epithelial thickness and overall mucosal health prior to surgery. At the time of surgery, we will obtain tissue for histologic and imaging analysis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 21 Years 至 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •21 to 70 years of age
- •Stage II or greater pelvic organ prolapse (POP)
- •Individuals electing surgery to treat their POP
- •Willing and able to comply with study procedures
- •Willing and able to provide written informed consent
排除标准
- •Contraindication for estrogen cream
- •Any medical condition that in the opinion of the investigator would place the subject at increased risk for participation
- •History of connective tissue disease
- •Previous hysterectomy or pelvic organ prolapse surgery
- •Known allergic reaction to any agent required by the protocol
- •Use of hormone therapy in postmenopausal women in the last 90 days
- •Pregnant or lactating females
- •History of prior noncompliance or the presence or history of psychiatric condition that would in the opinion of the investigator make it difficult for the subject to comply with study procedures or follow instructions
研究组 & 干预措施
Postmenopausal, topical vaginal cream
Postmenopausal participants randomized to topical vaginal cream containing estrogen or placebo for about one month's use prior to scheduled surgery. These will include those women randomized to estrogen cream.
干预措施: Postmenopausal, topical vaginal estrogen cream (Drug)
结局指标
主要结局
Vaginal Epithelial Thickness
时间窗: Change in thickness visit 1 to visit 2 for the postmenopausal group (approximately 1 month apart), and change in thickness from follicular to luteal phase for premenopausal group (approximately 1 month apart).
Measure of vaginal epithelial thickness obtained by optical coherence tomography
次要结局
- Histologic Assessment of Excised Tissue(1 month after visit 1 (3-17days after visit 2))