NCT01299363已完成4 期
Vaginal Dilators for Prevention of De Novo Dyspareunia After Prolapse Surgery: A Randomized Controlled Trial
Medstar Health Research Institute2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2010年9月1日最近更新:
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- To compare rates of de novo dyspareunia in women with and without vaginal dilator use following surgery for pelvic organ prolapse with posterior repair (colporrhaphy).
研究概览
简要总结
This is a randomized clinical trial comparing rates of de novo dyspareunia in women with and without vaginal dilator use following surgery for pelvic organ prolapse with traditional posterior repair. Our hypothesis is daily use of vaginal dilators from post-op week 4 through week 8 after posterior repair will reduce the rate of de novo dyspareunia.
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
- 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
- •Women who undergo pelvic organ prolapse surgery with a posterior repair
- •Age ≥18 years
- •Sexually active with heterosexual vaginal intercourse
- •English speaking
- •Available for 6 month follow up
- •Able to complete study questionnaires
- •Able to use dilators
排除标准
- •Significant baseline dyspareunia
- •Pregnancy by self-report or positive pregnancy test
- •Prior pelvic radiation therapy
- •Active pelvic infection, herpes, candidiasis
结局指标
主要结局
To compare rates of de novo dyspareunia in women with and without vaginal dilator use following surgery for pelvic organ prolapse with posterior repair (colporrhaphy).
时间窗: 6 months
次要结局
- Sexual function(6 month)
- Physical exam(6 months)
研究者
研究点 (2)
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