Optimized Acupuncture Treatment for Female Stress Urinary Incontinence: a Study Protocol for a Multicenter Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 360
- 试验地点
- 1
- 主要终点
- The change of urine leakage measured by the 1-hour pad test
研究概览
简要总结
This multicenter randomized controlled trial is designed to explore a relatively suitable application of acupoint combinations and to provide certain clinical evidence for the optimization of acupuncture treatment of female SUI.
详细描述
Stress urinary incontinence (SUI) mainly refers to the involuntary leakage of urine when abdominal pressure increases, such as sneezing, coughing, laughing or exercise. According to epidemiological studies, the global median prevalence of female urinary incontinence is 27.6% (4.8%-58.4%), of which SUI accounts for more than 50%. Previous study have demonstrated that acupuncture intervention can reduce the urine leakage in pad test, decrease the ICIQ-SF score, so as to help the patients alleviate the symptoms and improve their quality of life. This multicenter randomized controlled trial set 3 groups. Patients will receive 3 different applications of acupoint combinations so that the optimization of acupuncture treatment of female SUI will be find.
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
- 40 Years 至 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Patients with mild to moderate SUI mentioned in the diagnostic criteria above;
- •Aged 40～75 years;
- •Sign the informed consent.
排除标准
- •Other types of urinary incontinence (urgent, overflow or mixed).
- •History of urinary incontinence surgery or pelvic floor surgery;
- •Pelvic organ prolapse ≥ stage II;
- •Symptomatic urinary tract infection;
- •Residual urine volume > 30 mL;
- •Maximum urinary flow rate < 20ml/s.
- •Limitation of movement (walk and/or run and/or climb stairs);
- •Patients who have been using drugs that may affect bladder function or receiving SUI specialized treatment;
- •Severe cardiovascular, cerebral, liver, kidney and hematopoietic system disease, mental disorders, diabetes, multiple system atrophy, cauda equina neuropathy and spinal cord disease;
- •Pregnancy or lactation period.
- •With cardiac pacemaker, acupuncture phobia or metal allergies;
结局指标
主要结局
The change of urine leakage measured by the 1-hour pad test
时间窗: Week 6
Quantity of fluid loss will be measured by 1-hour pad test, compared with the baseline (week 0).
次要结局
- Urethral funnel formation by pelvic floor ultrasonography(Week 6)
- Participant Self-evaluation of Therapeutic Effects(Week 4, 6, 18, 30, 42 and 54)
- The number of patients who used other treatment for SUI(Week 18, 30, 42 and 54)
- Incidence of adverse events(Week 1-6)
- Lowest point of bladder by pelvic floor ultrasonography(Week 6)
- Severity of SUI according to '72 hours bladder diary'(Week 4, 6, 18, 30, 42 and 54)
- The type of bladder bulging by pelvic floor ultrasonography(Week 6)
- Subgroup analysis: correlation between 1-hour pad test and severity of SUI(Week 6)
- Number of urine pads used weekly(Week 4, 6, 18, 30, 42 and 54)
- Evaluation of discomfort during treatment(Within 5 minutes after the first and ninth acupuncture treatment)
- The change of mean episodes of urinary incontinence in 72 hours(Week 4, 6, 18, 30, 42 and 54)
- Urethral rotation angle by pelvic floor ultrasonography(Week 6)
- Retrovesical angle by pelvic floor ultrasonography(Week 6)
- The change of International Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF)(Week 4, 6, 18, 30, 42 and 54)
- Bladder neck mobility by pelvic floor ultrasonography(Week 6)
- Subgroup analysis: correlation between episodes of urinary incontinence in 72 hours and severity of SUI(Week18, 30, 42 and 54)
- Patient acceptability evaluation(Within 5 minutes after the first and ninth acupuncture treatment)
研究者
Yin Ping
Shanghai University of Traditional Chinese Medicine
Shanghai University of Traditional Chinese Medicine