Platelet-rich Fibrin Versus HIFU in Management of Stress Urinary Incontinence
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- Improvement of patient's comfort and satisfaction
研究概览
简要总结
Aim of the study is to compare effect of High Intensity Focused Ultrasound (HIFU) and platelet-rich fibrin in management of stress urinary incontinence.
It is a randomized prospective study. After assigning to one of the two groups, patients will undergo relevant treatment.
First group will undergo 3 cycles of intravaginal HIFU treatment in 6-weeks interval.
Second group will undergo 3 injections of platelet-rich fibrin under urethra. Before the treatment and after 2, 6 and 12 months after treatment is finished patients will be asked to fill questionaries concerning quality of life ICIQ-UI SF, ICIQ-LUTS, PISQ12, FSFI.
Before each treatment cycle patients will be examined and asked to fill daily micturition plan.
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 60 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •stress urinary incontinence of low grade
- •separate episodes of urinary incontinence (associated with increase of abdominal pressure)
- •no cystocoele or cystocoele POPQ1
- •positive cough test when filled bladder
排除标准
- •POPQ 2 and more
- •patients after urogenital operations or radiation
- •neuromuscular, hematologic, autoimmune, uncontrolled psychiatric diseases
- •uncontrolled diabetes
- •pregnancy, lactation
- •patients undergoing conservative treatment for stress urinary incontinence
- •ASA or other anti-platelet drug intake less than 7 days before and 7 days after procedure
- •active carcinomas or status less than 5 years after treatment
- •infection in treated region
结局指标
主要结局
Improvement of patient's comfort and satisfaction
时间窗: 1 year
Improvement of patient's comfort and satisfaction measured in questionnaire ICIQ-UI SF (International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form), scale 0-21 points, higher score meaning worse outcome.
次要结局
未报告次要终点
研究者
Tomasz Basta
Principal Investigator
Intima Clinic