Multicenter Prospective Randomized Trial Comparing to Strategies When Incontinence Surgery is Needed in Addition to Prolapse Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 194
- 主要终点
- Any or no leakage of urine when coughing
研究概览
简要总结
It is unknown whether it is best to do the TVT( procedure for urinary stress incontinence in women) at the time of prolapse surgery or at a later date. Women with both conditions were randomized to both procedures together or the TVT 3 months after the prolapse surgery. Any or no leakage when couching was the main end-point, evaluated 1 year after the last surgery
详细描述
All women were evaluated by the POP-Q (pelvic Organ Prolapse Quantification) prior to surgery and 1 year after.
Examination for urinary leakage was done prior to surgery and 1 year after. Group 2 was also examined after prolapse surgery to see if TVT was still needed.
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
- •Pelvic Organ Prolapse that needs surgical repair and objectively proven urinary stress incontinence -
排除标准
- •Not agreed to participate in randomization
研究组 & 干预措施
1
Group I, Prolapse repair and TVT concomitantly
干预措施: Vaginal Repair for prolapse, TVT procedure (Procedure)
1
Group I, Prolapse repair and TVT concomitantly
干预措施: TVT and Prolapse surgery (Procedure)
2
Group II, Prolapse repair and TVT 3 months afterwards if necessary
干预措施: Vaginal Repair for prolapse, TVT procedure (Procedure)
2
Group II, Prolapse repair and TVT 3 months afterwards if necessary
干预措施: TVT and Prolapse surgery (Procedure)
结局指标
主要结局
Any or no leakage of urine when coughing
时间窗: 1 year
次要结局
- The cure of urinary stress incontinence (USI) by only prolapse surgery(1 year)
- Result of prolapse surgery in two intervention strategies in women suffering from both genital prolapse and USI(1 year)