Comparison of Minisling Suburethral Sling Use and Laparoscopic Buch Colposuspension Application in Terms of Surgical Efficacy and Side Effects in True Stress Urinary Incontinence Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- urinary stress test for evaluating objective cure
研究概览
简要总结
When the studies in the literature including the mini-sling procedure and the laparoscopic buch colposuspension procedure are examined, it is seen that both methods are successful in the surgical treatment of stress urinary incontinence (SUI), but there is no study in which both procedures have been found to be superior to each other in terms of efficacy and safety. The aim of this study is to compare the minisling suburethral sling and laparoscopic buch colposuspension application in terms of efficacy and side effects in patients who will undergo surgical treatment due to genuine SUI.
详细描述
When the studies in the literature including the mini-sling procedure and the laparoscopic buch colposuspension procedure are examined, it is seen that both methods are successful in the surgical treatment of stress urinery incontinence (SUI), but there is no study in which both procedures have been found to be superior to each other in terms of efficacy and safety. The aim of this study is to compare the minisling suburethral sling and laparoscopic buch colposuspension application in terms of efficacy and side effects in patients who will undergo surgical treatment due to genuine SUI. Investigators planned to measure patients' Kings Health Questionary and Prolapse Quality of Life test at first and 6 months after the surgery and to determine how the operation affects the quality of life.
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
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •To be between the ages of 18-80
- •Isolated genuine stress incontinence or accompanying pelvic organ prolapse
- •Having accepted surgery for stress urinary incontinence -
排除标准
- •Previously undergo pelvic organ prolapse surgery
- •Having a chronic lung disease such as asthma or Chronic obstructive pulmonary disease (COPD)
- •Having juvenile diabetes mellitus
- •History of gynecological cancer
- •Mesh allergy
结局指标
主要结局
urinary stress test for evaluating objective cure
时间窗: changes in urodynamics test at postoperative first and the 6th month
In the postoperative period, urodynamics test will be determined at the 6th month and the absence of incontinence will be considered a cure.
次要结局
- Prolapse quality of life (P-QoL) scale(changes at postoperative first and the 6th month)
- subjective continence(changes at postoperative first and the 6th month)
- Female sexual function scale (FSFI)(changes at postoperative first and the 6th month)
- King's Health Questionnaire(changes at postoperative first and the 6th month)
研究者
Gamze Nur Cimilli Şenocak
assistant professor
Ataturk University