Vaginal Estradiol Use in Pessary Management: A Randomized Controlled Trial
试验速览
- 阶段
- 早期 1 期
- 状态
- 终止
- 入组人数
- 11
- 试验地点
- 1
- 主要终点
- Pessary Discontinuation Rates
研究概览
简要总结
The primary outcome of this study compare the rate of pessary discontinuation at 6 months post-pessary fitting in women using vaginal estradiol versus those not using vaginal estradiol.
详细描述
The purpose of the study is to investigate the effects of vaginal estradiol cream on pessary care. All patients presenting to the University of South Florida Urogynecology clinic for pessary fitting for pelvic organ prolapse and/or urinary incontinence are screened as potential study participants. After being informed of risks and benefits of participations and consent is obtained, patients that have been successfully fitted for a pessary and agree to participate will be separated into two groups: the control group or treatment group. The treatment group will be provided with a prescription for vaginal estradiol cream. Vaginal estradiol cream is FDA approved and is the first line treatment for vaginal atrophy, also known as dryness. The study will be unblinded and randomized, neither the participant nor the study doctor will choose which group the will be participant will be placed in. The participant will have an equal chance of being given either treatment. The treatment group will be asked to apply vaginal estradiol cream nightly for two weeks and then twice weekly thereafter. All participants will have 2 study visits over a 6-month period which is standard for pessary care: a regular follow up pessary check visit two weeks after pessary fitting and second visit 6 months later. At these visits, questions regarding symptoms including vaginal bleeding, vaginal discharge, and discomfort with pessary will be assessed and a physical exam will be performed as is standard for all pessary users.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Age ≥ 18 years
- •Postmenopausal status
- •Recent pessary fitting
- •Office-based and home-based pessary care
排除标准
- •Women < 18 years old
- •Women currently on hormone replacement therapy (pill, patch, pellet)
- •Women currently using vaginal estradiol cream within the last 4 weeks
- •Medical contraindications to vaginal estradiol including unevaluated vaginal bleeding
- •Inability to apply vaginal estradiol cream
- •Inability to provide informed consent
- •Inability to comprehend written and/or spoken English or Spanish
- •Inability to comply with study visit schedule
研究组 & 干预措施
Estrogen Group
Participants will receive standard pessary care, and those participants randomized to the experimental group will then be given a prescription for vaginal estradiol and instructed to apply it in the vagina nightly for two weeks and then twice weekly thereafter. Participation requires follow up visit 6 months from initial baseline visit. At this visit, participants are asked about vaginal bleeding, degree of bother due to vaginal discharge, and degree of pessary discomfort and a physical exam is performed.
干预措施: Estradiol vaginal cream (Drug)
结局指标
主要结局
Pessary Discontinuation Rates
时间窗: 6 Months Post-Pessary Fitting
To compare the rate of pessary discontinuation at 6 months post-pessary fitting in estrogen group and no intervention group
次要结局
- Unscheduled office visits(6 Months Post-Pessary Fitting)
- Phone calls/messages(6 Months Post-Pessary Fitting)
- Urinary Tract Infection Rates(Final Visit (6 Months Post-Pessary Fitting))
- Vaginal Erosion Rates(Final Visit (6 Months Post-Pessary Fitting))
- Vaginal Bleeding(Baseline Visit (Pessary Fitting), Final Visit (6 Months Post-Pessary Fitting))
- Pessary Discomfort(Baseline Visit (Pessary Fitting), Final Visit (6 Months Post-Pessary Fitting))
- Vaginal Discharge(Baseline Visit (Pessary Fitting), Final Visit (6 Months Post-Pessary Fitting))