Randomized Trial of rPMS Pelvic Floor Stimulation Device Compared With Pelvic Floor Exercises for Treatment of Urinary Incontinence
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 4
- 主要终点
- Evaluation of incontinence episodes using Bladder diary
研究概览
简要总结
This study will compare the clinical efficacy and safety between rPMS device and pelvic floor exercises for the treatment of urinary incontinence. The subjects will be enrolled and assigned into two study groups - active and control group. Subjects will be required to complete six (6) treatment visits and five follow-up visits - 1, 3, 6, 9 and 12 months after the final treatment.
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
- 25 Years 至 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female aged 25-70 years
- •Suffers from specific types of UI - Stress Urinary Incontinence (SUI), Urge Urinary Incontinence (UUI) and/or Mixed Urinary Incontinence (MUI)
- •Voluntarily signed informed consent form
- •Subjects willing and able to abstain from partaking in any treatment of urinary incontinence other than the study procedure
- •Subjects currently undergoing any treatment for stress, urge and/or mixed urinary incontinence, have to undergo a two-week wash-out period before start of the study
排除标准
- •Use of Botox® in the bladder or pelvic muscles in the last year
- •Use of Interstim® or similar device for the treatment of UI
- •Suffers from other types of urinary incontinence other than SUI, UUI, MUI
- •Pelvic organ prolapse grade 2 and higher
- •Pronounced lesions of the pudendus nerve during clinical neurophysiological examination
- •Currently lactating
- •Cardiac pacemakers
- •Implanted defibrillators and/or neurostimulators
- •Electronic implants
- •Metal implants, including copper IUD
- •Drug pumps
- •Hemorrhagic conditions
- •Anticoagulation therapy
- •Pregnancy
- •Following recent surgical procedures when muscle contraction may disrupt the healing process
- •Application over areas of the skin which lack normal sensation
- •Any disorders that the Investigator deems would interfere with study endpoints or subject safety
研究组 & 干预措施
Control Group
Control group
干预措施: Pelvic floor muscle training (Procedure)
Treatment Group
Treatment with the investigational device - rPMS
干预措施: rPMS device (Device)
结局指标
主要结局
Evaluation of incontinence episodes using Bladder diary
时间窗: 13 months
Evaluation of change in incontinence episodes before and after the study treatment in both study groups.
Evaluation of quality of life improvement using the Pad Usage Questionnaire
时间窗: 13 months
Evaluation of change in Pad Usage Questionnaire before and after the study treatment in both study groups. Decrease in number of used pads will be considered as an improvement.
Evaluation of quality of life improvement using the UDI-6 questionnaire
时间窗: 13 months
Evaluation of change in UDI-6 score before and after the study treatment in both study groups. Decrease of the score will be considered as an improvement.
Evaluation of quality of life improvement using the ICIQ-LUTSqol questionnaire
时间窗: 13 months
Evaluation of change in ICIQ-LUTSqol score before and after the study treatment in both study groups. Decrease of the score will be considered as an improvement.
Evaluation of pelvic floor muscle strength
时间窗: 13 months
Evaluation of pelvic floor muscle strength with measurement of voluntary contraction in both study groups.
次要结局
- Subject Satisfaction evaluation(13 months)
- Safety evaluation(13 months)
- Therapy comfort evaluation(1 month)