Urinary Incontinence After Radical Prostatectomy
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 66
- 试验地点
- 2
- 主要终点
- 24-hour pad weigh test
研究概览
简要总结
The aims of this project are; 1) To examine the efficacy of ultrasound-guided pelvic floor muscle training compared to standard care on urinary incontinence in patients undergoing robot assisted radical prostatectomy and 2) To compare physical function, incontinence, and QoL in two groups of patients with low or high function of the pelvic floor muscles respectively before the surgery.
This study consists of two parts. The first part is a randomized controlled trial where 44 patients with weak pelvic floor muscle function are randomized to either treatment as usual (control group 1) or ultrasound-guided pelvic floor muscle training (Intervention group). In the second part the patients in control group 1 will be compared with 22 patients with normal/strong pelvic floor muscle function (control group 2).
Patients not able to perform the pelvic floor muscle test consisting of 8 repetitions of 4-seconds pelvic floor muscle contraction and 1 repetition of 15-seconds pelvic floor muscle contraction will be randomized to either intervention group or control group 1. Patients able to perform the pelvic floor muscle test will be included in control group 2.
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
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Men aged 18 and above
- •Diagnosis of prostatic adenocarcinoma and referred to robot assisted radical prostatectomy
- •No comorbidity that prevents pelvic floor training or effects the function of the pelvic floor
- •Adequacy in written and spoken Danish Performance status 0-1
- •Able to understand the study procedures and willing to provide written informed consent
排除标准
- •Major surgery within the last month that may affect pelvic floor function.
- •Urinary incontinence prior to surgery
结局指标
主要结局
24-hour pad weigh test
时间窗: 12 month after the operation
The patients have to weigh their pads before use and retain them in sealed plastic bags for repeated weight assessment when the 24-hour period has ended. The total increase in weight (gram) of all the pads will be recorded
次要结局
未报告次要终点
研究者
Sara Birch
Principal investigator
Regional Hospital West Jutland