Impact of Vaginal Estrogen in the Treatment of Symptomatic Mild Pelvic Organ Prolapse With Pelvic Floor Physical Therapy
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 53
- 试验地点
- 1
- 主要终点
- Patient Global Impression of Improvement
研究概览
简要总结
This is a randomized controlled trial in which women with symptomatic mild pelvic organ prolapse undergoing Pelvic Floor Physical Therapy (PFPT) receive vaginal estrogen versus placebo to see if a combined approach to treatment leads to improvement in clinical outcomes. The investigators predict that PFPT in combination with vaginal estrogen will lead to decreased pelvic floor symptoms and improved anatomical support corroborated by biomarker data.
详细描述
The pathogenesis of pelvic organ prolapse (POP) is unknown. Few studies have correlated patient symptoms and amount of prolapse with biomarkers. POP has traditionally been managed with a pessary or surgery. Recent studies suggest a reduction in POP symptoms following Pelvic Floor Physical Therapy (PFPT). Vaginally delivered hormones are also commonly used to treat prolapse symptoms, with little evidence supporting a clinical benefit. The investigators hypothesize that the optimal approach to improving prolapse symptoms in the patient with mild prolapse requires re-alignment and strengthening of levator muscles via PFPT, and optimization of tissue integrity via local estrogen therapy. The investigators propose to test this hypothesis in a randomized controlled trial in which women with symptomatic mild prolapse opting for PFPT, receive treatment with PFPT in combination with vaginal estrogen versus placebo. The investigators predict that the combined approach will lead to decreased symptoms and improved anatomical support corroborated by biomarker data.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 80 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women in good health aged 40-80
- •Has symptoms of pelvic organ prolapse; answers yes to at least 1 of the following questions:
- •Do you feel or see a vaginal bulge? Do you feel pressure in the vagina?
- •Meets POP-Q criteria on exam for stage I, II, or III prolapse
- •Interested in PFPT for management of POP
- •Normal mammogram within 1 year of enrollment
排除标准
- •Prior surgery for prolapse or incontinence
- •Other prior interventions for prolapse (e.g. pessary, PFPT)
- •Previous bilateral salpingo-oophorectomy (women with 1 ovary will be eligible)
- •Known liver dysfunction
- •Connective tissue diseases known to affect collagen or elastin remodeling (including: Lupus, Rheumatoid Arthritis, Scleroderma, Sjogrens syndrome, Marfan syndrome, and Ehlers-Danlos syndrome)
- •Unevaluated abnormal vaginal bleeding or abnormal pap smear in the previous year
- •BMI > 35 kg/m2
- •Estrogen therapy (including birth control) in the previous year
- •Current or prior breast or pelvic malignancy (ovarian, tubal, uterine, cervical or vaginal)
- •Contraindication to hormone use (i.e. thromboembolic disorder, use of anti-coagulants, coronary artery disease, history of stroke)
研究组 & 干预措施
Vaginal estrogen
Patients in the experimental group will receive vaginal estrogen cream
干预措施: Vaginal estrogen (Drug)
Placebo cream
Patients in the comparison group will receive placebo vaginal cream
干预措施: Placebo (Drug)
结局指标
主要结局
Patient Global Impression of Improvement
时间窗: 6 months after starting vaginal cream
The Patient Global Impression of Improvement (PGI-I) is a global index that may be used to rate the response of a condition to a therapy (transition scale). It is a simple, direct, easy to use scale that is intuitively understandable to clinicians. Potential Responses: 1. Very Much Better 2. Much Better 3. A Little Better 4. No Change 5, A Little Worse 6. Much Worse 7. Very Much Worse Lower scores indicate more imiprovment / better outcome.
次要结局
- Pelvic Floor Symptoms(6 months)
- General Quality of Life(6 months)
- Pelvic Organ Prolapse Stage(6 months)
- Collagenase Activity(6 months)
- Sexual Function(6 months)
研究者
Pamela Moalli
Associate Professor
University of Pittsburgh