Efficacy of Personalized Extracorporeal Biofeedback Device for Pelvic Floor Muscle Training on Post-prostatectomy Incontinence
试验速览
- 阶段
- 不适用
- 入组人数
- 84
- 试验地点
- 1
- 主要终点
- Recovery of urinary continence
研究概览
简要总结
To evaluate the efficacy of postoperative pelvic floor muscle training using personalized extracorporeal biofeedback device among patients with post-prostatectomy incontinence
详细描述
- Post prostatectomy urinary incontinence (PPI) was common complication after radical prostatectomy among prostate cancer patients.
- The prevalence of post-prostatectomy urinary incontinence was reported at 87%.
- The pelvic floor muscle therapy (PFMT) using Kegel exercise was first methods to prevent PPI after prostatectomy.
- However, there was no standardized protocol of the PFMT and it was necessary of biofeedback to PFMT.
- Therefore, we hypothesis the efficacy of personalized device of PFMT with biofeedback among patients who underwent radical prostatectomy
- In this study, we evaluate the efficacy of postoperative pelvic floor muscle training using personalized extracorporeal biofeedback device among patients with post-prostatectomy incontinence.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 85 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Prostate cancer patients who underwent robotic radical prostatectomy
- •Neurovascular saving at least one side
- •Bladder neck reconstruction at prostatectomy
- •Posterior reconstruction at prostatectomy
- •Patients who have post-prostatectomy incontinence after Foley catheter removal
排除标准
- •Patients who have not post-prostatectomy incontinence after Foley catheter removal
- •Neurological deficits
- •Anatomic deformities of pelvic bone
- •Pelvic irradiation history
- •History of other major urological procedures
- •Complications influencing urinary incontinence
研究组 & 干预措施
Kegel exercise education
Prostate cancer patients of control group will received Kegel exercise education for pelvic floor muscle exercise (PFME) to improve the post-prostatectomy incontinence after robot-assisted laparoscopic radical prostatectomy.
Extracorporeal biofeedback device
Prostate cancer patients of intervention group will received extracorporeal biofeedback device (Any Kegel) for pelvic floor muscle exercise (PFME) to improve the post-prostatectomy incontinence after robot-assisted laparoscopic radical prostatectomy.
干预措施: Extracorporeal biofeedback device (Any Kegel) (Device)
结局指标
主要结局
Recovery of urinary continence
时间窗: postoperative 1 month
weight of pad (g) by 24 hours pad test
次要结局
- Recovery of urinary continence(postoperative 1 and 3 months)
- Recovery of urinary continence(postoperative 3 month)
研究者
Seok-Soo Byun
Professor
Seoul National University Hospital