NCT02837796已完成不适用
Effects of Trans-Obturator Tape outside-in Versus Inside-out Procedure for Stres Urinary Incontinence
Istanbul Bakirkoy Maternity and Children Diseases Hospital0 个研究点目标入组 101 人开始时间: 2013年9月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 101
- 主要终点
- postoperative differences at physical PISQ-12 score
研究概览
简要总结
The investigators think that the two techniques of TOT (inside-out and outside-in) procedures both statistically improve the sexual functions, psychosocial state and quality of life after the surgery. Additionally postoperative physical and behavioral-emotional scores in PISQ-12 were statistically more increase in inside-out group than the outside-in group.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •pure urodynamic SUI
- •sexual active before and 2 months after the surgery
- •married or single
- •aged over 20
- •have cured after TOT operation
排除标准
- •preoperative or postoperative detrusor disfunction
- •previous history of malignancy
- •prior vaginal surgery
- •a partner with sexual incapabilities
- •a concomitant gynecologic disorder
- •patients with pelvic organ prolapse over stage II
- •pelvic radiotherapy and a history of psychological diseases
- •participants who had no sexual activity with in the past two months
结局指标
主要结局
postoperative differences at physical PISQ-12 score
时间窗: 1 year
postoperative differences at emotional-behavioral PISQ-12 score
时间窗: 1 year
次要结局
未报告次要终点
研究者
Osman Aşıcıoğlu
medical doctor
Istanbul Bakirkoy Maternity and Children Diseases Hospital
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