Evaluating Sexual Function After Vaginal Repair With Perineorrhaphy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 44
- 试验地点
- 2
- 主要终点
- Change in sexual function as measured by validated questionnaire
研究概览
简要总结
This is a single center, double-blind, randomized controlled trial evaluating the change in sexual function in women undergoing vaginal repair for pelvic organ prolapse. Participants will be sexually active women who agree to randomization to having perineorrhaphy added to or excluded from their surgical repair. We hypothesize that sexual function will improve more significantly in women undergoing vaginal repair with perineorrhaphy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 19 Years 至 105 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •sexually active
- •genital hiatus measured between 4 and 6 centimeters
- •desires sexual function
- •undergoing vaginal repair with native tissues
- •agrees to use vaginal estrogen for 12 months after surgery
排除标准
- •genital hiatus > 6 cm
- •planned obliterative procedure
- •perineal body length <0.5cm
- •disrupted external anal sphincter
研究组 & 干预措施
No perineorrhaphy
Subjects will not have a perineorrhaphy procedure added to the vaginal prolapse repair
Perineorrhaphy
Subjects will have a perineorrhaphy added to the vaginal repair of prolapse
干预措施: Perineorrhaphy (Procedure)
结局指标
主要结局
Change in sexual function as measured by validated questionnaire
时间窗: 6 months and 12 months after surgery
Validated questionnaires will be administered prior to surgery, as well as at intervals after surgery.
次要结局
- Prolapse recurrence(6 months, 12 months)