Use of Vaginal Estrogen With Pessary Treatment of Pelvic Organ Prolapse and Urinary Incontinence
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Vaginal infections
研究概览
简要总结
Patients presenting with pelvic organ prolapse will be offered the use of a pessary. Vaginal estrogen cream treatment with the pessary will be randomized amongst the patients and patient satisfaction and complication rates will be assessed during follow-up.
详细描述
This will be a double-blinded, placebo-controlled, randomized controlled trial. Eligible patients presenting to the urogynaecology clinic with pelvic organ prolapse will be offered management with a pessary and participation in the study
Patients who agree to participate in the study will be given a consent form
Patients in the study and thus those who have opted for pessary use will be randomized between two groups:
- Treatment group - will be given instructions for use and prescription for Premarin vaginal cream 2g at bedtime twice weekly
- Control group - will utilize pessary with an inactive placebo cream
Both the patient and the investigators will be blinded to patient treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Any patient presenting to the clinic with pelvic organ prolapse will be offered management with a pessary and will be offered participation in the study.
排除标准
- •have a contraindication to the use of estrogen cream or products
- •have any allergy to the use of estrogen cream or products
- •have a past medical or family history of breast cancer
- •have a past medical history of thromboembolism, myocardial infarction and stroke or are pregnant
- •have previously used Premarin vaginal cream
- •are currently using oral estrogen
- •are not competent to consent
研究组 & 干预措施
Treatment group
These patients will utilize a pessary and be given instructions for use and prescription for Premarin vaginal cream 2g at bedtime twice weekly.
干预措施: Premarin vaginal cream (Drug)
Control group
These patients will utilize a pessary with an inactive placebo cream.
干预措施: Placebo cream (Drug)
结局指标
主要结局
Vaginal infections
时间窗: 60 weeks
Vaginal swabs at each follow up visit will be used to detect presence or absence of vaginal infection. A total count of vaginal infections per patient will be compared between groups.
次要结局
- Frequency of urinary tract infection(60 weeks)
- Quality of life(60 weeks)