NCT03539107已完成不适用
Voiding Assessment Based on Minimum Spontaneous Void of 150 mL Compared to Retrograde Fill Method After Female Pelvic Floor Reconstructive Surgery: A Randomized Controlled Trial
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 110
- 试验地点
- 2
- 主要终点
- Failure rate
研究概览
简要总结
This study will compare voiding assessment based on a minimum spontaneous voided volume of 150 cc with the standard retrograde fill approach in women after pelvic floor procedures.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 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
- •All 18-year-old or older women who undergo surgery for urinary incontinence and/or pelvic organ prolapse (POP)
排除标准
- •Patients who require prolonged Foley catheter or suprapubic catheter
结局指标
主要结局
Failure rate
时间窗: Up to 2 days post op
The percentage of subjects who did not meet the required voiding assessment criteria and needed catheterization .
次要结局
- Patient Satisfaction Questionnaire for Voiding Assessment-method used(Up to 2 days post-surgery.)
- Force of stream (FOS)(Up to 2 days post-surgery.)
- False pass rate(up to 30 days after discharge.)
- Patient Satisfaction Questionnaire for Voiding Assessment-negative emotions(Up to 2 days post-surgery.)
- Patient Satisfaction Questionnaire for Voiding Assessment-preferred method(Up to 2 days post-surgery.)
- Urinary tract infection (UTI)(Up to 30 days post surgery.)
- Length of hospital stay(Up to 2 days post-surgery.)
- Patient Satisfaction Questionnaire for Voiding Assessment-recommend method(Up to 2 days post-surgery.)
- Patient Satisfaction Questionnaire for Voiding Assessment-convenience of method(Up to 2 days post-surgery.)
- Postoperative pain score(One day post-surgery.)
- Post-operative complications(Up to 30 days post-surgery.)
研究者
研究点 (2)
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