Comparison of Anatomical and Subjective Short-term Outcomes of TOT, TVT, and Burch Colposuspension: A Randomized Controlled Trial Using Transperineal Ultrasound
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Change in Urethrovesical and Urethral Angles Assessed by Transperineal Ultrasound
研究概览
简要总结
Stress urinary incontinence is a common condition in women and is often treated with surgical procedures such as transobturator tape (TOT), tension-free vaginal tape (TVT), and Burch colposuspension. Although these procedures are widely used, there is limited information comparing their short-term anatomical and patient-reported outcomes using imaging techniques.
The aim of this study is to compare the short-term anatomical and subjective outcomes of TOT, TVT, and Burch colposuspension in women with stress urinary incontinence. Transperineal ultrasonography will be used to assess anatomical changes before surgery and during follow-up. Patient-reported outcomes and clinical findings will also be evaluated.
The results of this study may help improve the understanding of surgical outcomes in stress urinary incontinence and support clinical decision-making.
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
- Single (Participant)
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
- •Female patients aged 18 years or older
- •Diagnosis of stress urinary incontinence based on clinical evaluation
- •Candidates for surgical treatment with transobturator tape (TOT), tension-free vaginal tape (TVT), or Burch colposuspension
- •Ability to provide written informed consent
- •Willingness to participate in the study and comply with follow-up visits
排除标准
- •Mixed or urge-predominant urinary incontinence
- •Previous anti-incontinence or pelvic floor surgery
- •Neurogenic bladder disorders
- •Active urinary tract infection at the time of evaluation
- •Pregnancy or planned pregnancy during the study period
- •Known pelvic malignancy
- •Inability to undergo transperineal ultrasonographic evaluation
结局指标
主要结局
Change in Urethrovesical and Urethral Angles Assessed by Transperineal Ultrasound
时间窗: Baseline (preoperative) and 3 months postoperatively
The primary outcome is the change in urethrovesical and urethral angles measured by transperineal ultrasonography before surgery and at 3 months after surgery.
次要结局
- Subjective Improvement in Stress Urinary Incontinence Symptoms(Baseline and 3 months postoperatively)
- Subjective Improvement in Stress Urinary Incontinence Symptoms(Baseline and 3 months postoperatively)
研究者
gizem boz izceyhan
doctor
Zeynep Kamil Maternity and Pediatric Research and Training Hospital