A Multi-center, Randomized, Open-label, Parallel-group, Feasibility-controlled Trial of Vaginal Estrogen for Improvement of Outcomes Following Pelvic Organ Prolapse Surgery
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- Sarah Wozney
- 入组人数
- 180
- 试验地点
- 4
- 主要终点
- Recruitment Rate
研究概览
简要总结
This open-label randomized control trial will study the use of vaginal estrogen in the first six weeks after pelvic organ prolapse (POP) repair surgery. This is a pilot trial that will examine the feasibility of the study, focussing on recruitment rates. Participants will be randomized to one of three groups; (1) no vaginal estrogen for 6 weeks, (2) vaginal estrogen twice weekly for 6 weeks, or (3) vaginal estrogen daily for 6 weeks. Participants will be seen at 6 weeks post surgery, 6 months post surgery, 1 year and 2 years post surgery. Additional outcomes will include patient satisfaction, Genitourinary Syndrome of Menopause (GSM) symptoms, post-operative complications, adherence and safety.
详细描述
Multi-center, randomized, open-label, parallel-group, feasibility-controlled trial
The intervention is the use of vaginal estrogen for 6 weeks after pelvic organ prolapse surgery. Participants will be randomized into 3 groups:
- No vaginal estrogen
- Vaginal estrogen 2 times per week
- Vaginal estrogen daily
Participants may be enrolled after diagnosis of pelvic organ prolapse and decision to proceed with surgery. Participants will be seen for a randomization visit within 6 weeks of their scheduled surgery. The intervention lasts from the day of surgery until 6 weeks after surgery. Participants will be seen for a post-operative follow-up visit at 6 weeks, and study follow-up visits at 6 months, 1 year and 2 years.
Sample Size: N=60 in each group, for a total of N=180 participants. For this pilot trial, we will recruit approximately 15% of the sample size required for the full-scale trial. Data from this pilot trial will be used to adjust the event rate in the sample size calculation for the full trial, if needed. Our sample size accounts for a non-compliance rate of 5% and a loss to follow-up rate of 5%.
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 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Participants must meet all the following inclusion criteria to be eligible for enrollment into the study:
- •Participant who, in the opinion of the investigator, can and will comply with the requirements of the protocol.
- •The participant has given written consent after the study has been explained according to local regulatory requirements and before any study specific procedures.
- •Age ≥18 years at the time of consent.
- •Undergoing an apical suspension (vaginal or abdominal, mesh or native tissue) for pelvic organ prolapse at one of the participating centers.
- •Primary or recurrent prolapse surgery without a history of mesh surgery.
- •Willing to complete surveys related to demographics, pelvic health and function, and sexual health and function.
- •Plans to reside in the study area for at least 2 years after their surgery.
排除标准
- •Any individual meeting any of the following criteria is not eligible for participation in this study:
- •Participant undergoing anterior and/or posterior repair only (no apical prolapse repair).
- •Participant undergoing obliterative procedures.
- •Participant with a history of mesh surgery for prolapse.
- •Participant undergoing uterine sparing surgery.
- •Participant with a contraindication to vaginal estrogen use, including but not limited to the following list, at the discretion of the study investigator:
- •Patients who are hypersensitive to the drug or to any ingredient in the formulation or component of the container.
- •Liver dysfunction or disease as long as liver function tests have failed to return to normal.
- •Known or suspected estrogen-dependent malignant neoplasia (e.g. endometrial cancer).
- •Endometrial hyperplasia.
- •Known, suspected, or past history of breast cancer.
- •Undiagnosed abnormal genital bleeding.
- •Known or suspected pregnancy
- •Active or past history of arterial thromboembolic disease (e.g. stroke, myocardial infarction, coronary heart disease).
- •Partial or complete loss of vision due to ophthalmic vascular disease.
- •Known thrombophilic disorders (e.g., protein C, protein S OR antithrombin deficiency); prothrombin mutation or anticardiolipin antibodies).
- •Any conditions that, in the Investigator's judgement, may interfere with participant's ability to comply with study procedures or receipt of care, such as behavioral or cognitive impairment or neuropsychiatric illness.
- •Concurrently participating in another clinical study, at any time during the study period, in which the participant has been or will be exposed to an investigational or a non-investigational vaccine/product.
研究组 & 干预措施
No Vaginal Estrogen Group
No vaginal estrogen
Twice Weekly Vaginal Estrogen Group
Twice Weekly Vaginal Estrogen
干预措施: Vaginal Estrogen - Twice Weekly (Drug)
Daily Vaginal Estrogen Group
Daily Vaginal Estrogen
干预措施: Vaginal Estrogen - Daily (Drug)
结局指标
主要结局
Recruitment Rate
时间窗: 12 months
For the primary feasibility outcome, the trial will be considered feasible if at least 75% of the target sample can be recruited in 12 months.
次要结局
- Loss to Follow Up Rate - 1 year(1 year post surgery)
- Loss to Follow Up Rate - 6 months(6 Months post surgery)
- Loss to Follow Up Rate - 2 years(2 years post surgery)
- Patient Satisfaction - 6 weeks(6 weeks post surgery)
- Patient Satisfaction - 6 months(6 months post surgery)
- GSM Symptoms - 6 weeks(6 weeks post surgery)
- GSM Symptoms - 6 months(6 weeks post surgery)
- GSM Symptoms - 1 year(1 year post surgery)
- GSM Symptoms - 2 years(2 years post surgery)
- Prolapse Quality of Life - 6 weeks(6 weeks post surgery)
- Prolapse Quality of Life - 6 months(6 months post surgery)
- Prolapse Quality of Life - 1 year(1 year post surgery)
- Prolapse Quality of Life - 2 years(2 years post surgery)
- Complications - 6 weeks(6 weeks post surgery)
- Complications - 6 months(6 months post surgery)
- Treatment Failure - 1 year(1 year post surgery)
- Treatment Failure - 2 years(2 years post surgery)
研究者
Sarah Wozney
Assistant Professor
Queen's University