NCT02775526已完成不适用
Trans-Obturator Tape, Tension-Free Vaginal Tape and Burch Colposuspension for Treatment of Female Mixed Urinary Incontinence: A Randomized Clinical Trial
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 220
- 试验地点
- 1
- 主要终点
- objective cure rate
研究概览
简要总结
This prospective interventional randomized controlled trial will recruit women with MUI scheduled for surgical treatment where patients will be randomized to either Burch colposuspension, TOT or TVT. Regular postoperative follow up will be planned for at least 2 years. The primary outcome measures will be the objective and subjective cure rates.
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
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women with mixed urinary incontinence.
排除标准
- •Women with associated gynecological surgery e.g. uterine prolapse, previous anti-incontinence surgery, intrinsic sphincter deficiency (ISD), and medical disorders affecting the bladder innervation as diabetes mellitus were excluded from the study.
- •Women who improved on medical treatment with persistence of stress element only were also excluded.
研究组 & 干预措施
TOT
Active Comparator
TOT
干预措施: TOT (Procedure)
TVT
Active Comparator
TVT
干预措施: TVT (Procedure)
Burch colposuspension
Active Comparator
Burch colposuspension
干预措施: Burch Colposuspension (Procedure)
结局指标
主要结局
objective cure rate
时间窗: 2 years
subjective cure rate
时间窗: 2 years
次要结局
未报告次要终点
研究者
Mohamed S Sweed, MD
Dr
Ain Shams University
研究点 (1)
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