A Randomized, Double-blind, Placebo Controlled Clinical Trial to Investigate the Effects of Transpelvic Magnetic Stimulation (Using QRS®-1010 PelviCenter) in Patients With Stress Urinary Incontinence.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Change in International consultation on incontinence questionnaire for urinary incontinence-short form (ICIQ-UI SF)
研究概览
简要总结
The aim of the study is to investigate the effects of QRS®-1010 PelviCenter in female patients with stress urinary incontinence.
Based on the available data on magnetic stimulation, the investigators hypothesize that magnetic stimulation via QRS®-1010 PelviCenter will reduce the number and amount of urinary leakage upon exertion as well as improve patients' quality of life.
详细描述
A total of 120 female patients will be randomly assigned into two treatment groups (active arm and sham arm) in a 1:1 ratio. The standard QRS®-1010 PelviCenter treatment plan involves 16 sessions of 20 minutes each. Each subject will attend 2 sessions per week (total 16 sessions).
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female aged at least 21 years old
- •Demonstration of stress urinary incontinence by vaginal examination with half full bladder (200 to 250ml)
- •ICIQ UI SF score ≥ 6 points
- •Able and agree to carry out one hour pad test
排除标准
- •Acute severe infections
- •Urinary tract infections and hematuria, active vaginal lesions or infections
- •Pelvic organ prolapse stage III and IV, severe urethral sphincter weakness/defect, suspected fistula
- •Severe cardiac arrhythmia
- •Cardiac pacemaker or other implanted metallic devices
- •History of pelvic irradiation
- •Pregnant, or actively trying to conceive.
- •Neurologic conditions such as epilepsy, Parkinson disease, multiple sclerosis
- •Patient who has been treated with electromagnetic stimulation
- •Concurrent medications with alpha-adrenergic antagonists (e.g. terazosin, tamsulosin, doxazosin), diuretics, serotonin/norepinephrine reuptake inhibitors (SNRIs) or any other medications known to worsen incontinence.
- •Post void residual volume of ≥ 200ml
- •Random blood sugar >10 mmol/L
- •Patient who had pelvic or gynaecological surgery for less than three weeks
- •Patient scheduled for pelvic or gynaecological surgery in the next eight weeks
研究组 & 干预措施
Magnetic stimulation
Active magnetic stimulation delivered to the pelvic floor muscles
干预措施: Magnetic stimulation (Device)
Sham magnetic stimulation
Sham magnetic stimulation delivered to the pelvic floor muscles
干预措施: Sham magnetic stimulation (Device)
结局指标
主要结局
Change in International consultation on incontinence questionnaire for urinary incontinence-short form (ICIQ-UI SF)
时间窗: Baseline, Week 4, 8. Follow-up at 3-,6- and 12-months post treatment
次要结局
- Change in Incontinence Episode Frequency (IEF)(Baseline, Week 4, 8. Follow-up at 3-,6- and 12-months post treatment)
- Change in 1-hour exercise (stress) pad test(Baseline, Week 4, 8. Follow-up at 3-,6- and 12-months post treatment)
- Change in Patient Global Impression of Improvement (PGI-I)(Week 4, 8. Follow-up at 3-,6- and 12-months post treatment)
- Change in International consultation on incontinence questionnaire-Lower Urinary Tract Symptoms Quality of Life (ICIQ-LUTSqol)(Baseline, Week 4, 8. Follow-up at 3-,6- and 12-months post treatment)
研究者
Lim Renly
M. Pharm
QRS Asia Sdn Bhd