To Investigate the Effect of High-Intensity Focused Electromagnetic (HIFEM) Technology in the Treatment of Stress Urinary Incontinence Compared With Standard of Care in Chinese Men Who Had Undergone Robotic Radical Prostatectomy
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 184
- 试验地点
- 1
- 主要终点
- Weight of 1-hour pad test
研究概览
简要总结
This is a prospective, randomized trial to evaluate the efficacy and safety of High-Intensity Focused Electromagnetic (HIFEM) Technology in the treatment of stress urinary incontinence compared with standard of care in Chinese men who had undergone robotic radical prostatectomy.
详细描述
This is a prospective randomised control trial of consecutive patients with prostatectomy to have either standard of care versus HIFEM assisted pelvic floor exercise. Randomization will be performed for patients when the subject has completed the informed consent for study participation. Randomization will be performed in 1:1 ratio into 2 arms: HIFEM assisted (BTL EMsella) pelvic floor muscle training (Arm A) plus Standard of care or Standard of care (Arm B).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Months 至 —（Child, Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Undergone robotic radical prostatectomy
- •Able to carry out 1-hour pad test
- •Voluntary participation and signing of the informed consent form
排除标准
- •Pre-existing stress urinary incontinence
- •Post-void residual urine greater than 200ml
- •Active urinary tract infection
- •Urethral or bladder fistula
- •History of pelvic irradiation
- •Neurological condition (Spinal cord problems, stroke with poor neurological recovery, epilepsy, Parkinson disease, multiple sclerosis)
- •Previous surgery for SUI
- •Concurrent medication with diuretics, serotonin-norepinephrine reuptake inhibitors or any other medication known to worsen incontinence
- •Condition contraindicated for electromagnetic therapy i.e. Arrhythmia, on a pacemaker or implanted metallic device; Coagulopathy or on anticoagulant
研究组 & 干预措施
Standard of Care
Standard of care. Perioperative education for information related to prostatectomy and pelvic floor exercise training. Patient were advice to perform pelvic floor exercise at least 30 times per day
干预措施: Standard of care (Other)
EM Chair
Patients who randomised to intervention group (Arm A) will receive HIFEM assisted (BTL EMsella) pelvic floor muscle training for total 6 sessions (2 session per week, 30 minutes per session with modulated intensity) plus standard of care. The intervention will be started within 2 weeks after Foley Catheter removed. Patients will attend follow up for training and at 1, 3 and 6 month post-operatively.
干预措施: EM Chair (Device)
结局指标
主要结局
Weight of 1-hour pad test
时间窗: Baseline, Month 1, Month 3 and Month 6
Weight of 1-hour pad test
次要结局
- Severity of Incontinence.(Baseline, Month 1, Month 3 and Month 6)
- Sexual Function(Baseline, Month 1, Month 3 and Month 6)
- Severity of Incontinence(Baseline, Month 1, Month 3 and Month 6)
- Complications(Month 1, Month 3 and Month 6)
研究者
Chi Fai NG
Professor
Chinese University of Hong Kong