Effect of Electroacupuncture Versus PFMT Plus Solifenacin for Moderate and Severe Mixed Urinary Incontinence in Female: a Multicenter, Noninferiority, Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 500
- 试验地点
- 1
- 主要终点
- Percentage of Change From Baseline in 72-hour Incontinence Episode Frequency (IEF) Over Weeks 1-12
研究概览
简要总结
A noninferiority randomized controlled trial aimed at comparing the effect and safety of electroacupuncture versus the pelvic floor muscle training (PFMT) plus solifenacin for mixed urinary incontinence (MUI).
详细描述
Participants experiencing mixed urinary incontinence will be recruited from 10 centers. A gynecologist or urologist will make the diagnosis. Central randomization will be performed by the Clinical Evaluation Center of the China Academy of Chinese Medical Sciences in Beijing.
Sample size: Sample size is based on the primary outcome. According to literature, the investigators predict that MUI patient's average 72-h incontinence episode frequency of the week 1-12 will decrease by 60% from the baseline after treatment of PFMT plus solifenacin. The number of the acupuncture group is 57%. For the assessment of noninferiority, 250 participants will be needed for each group allowing for a 15% dropout (α=0.05，β=0.2，δ=15%).
Quality control: A 3-level monitoring system (monitors responsible for one center, monitors responsible for all centers and monitors responsible for the whole trial) will be established to check the performance of the trial in time. Outcome assessment, completion of case report forms and data management will be under strict supervision.
Data management: The Remote Dara Capture (RDC) system will be used for data entering. Both paper and electronic case report form will be reserved. A data verification plan is made.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 35 Years 至 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •females meet the meet the diagnostic criteria of mixed urinary incontinence
- •aged 35-75 years
- •moderate and severe urinary incontinence with the urinary incontinence severity index between 3 and 9
- •suffering from urinary incontinence at least for 3 months with the 72-h incontinence episode frequency≥2 in the baseline assessment
- •voluntarily join the research and sign the informed consent
排除标准
- •pure stress urinary incontinence, pure urgency urinary incontinence, overflow incontinence and neurogenic bladder
- •medicine use for urinary incontinence or may affect the bladder function, or taking any non-drug therapy (such as electric stimulation, bladder training and pelvic floor muscle training) in the last month
- •symptomatic urinary tract infection and non-functional urologic disease
- •having ever undergone an operation for urinary incontinence or on the pelvic floor (including hysterectomy)
- •pelvic organ prolapse degree ≥2
- •residual urinary volume (RUV) >30 mL
- •maximum flow rate (Qmax) <20 mL/s;
- •be allergic to solifenacin or having contradictions for muscarine antagonist (such as urinary retention, gastric retention, myasthenia gravis, ulcerative colitis and angle closure glaucoma)
- •diseases affect function of lower urinary tract, such as uncontrolled diabetes, multiple sclerosis, Alzheimer's disease, Parkinson's disease, spinal injury, cauda equina injury and multiple system atrophy.
- •serious cardiovascular, pulmonary, cerebral, liver, kidney, hematopoietic system or psychiatric disease and cognitive impairment
- •patients with severe renal dysfunction or moderate hepatic dysfunction who are using strong Cyp3a4 Inhibitor like ketoconazole
- •unable or limited to walking, up and down stairs and running
- •poor compliance with electroacupuncture, pelvic floor muscle training or drug
- •pregnancy, lactation or within the 12 months after birth
- •having a cardiac pacemaker, a metal allergy, or a severe needle phobia.
- •volunteer of other trials
研究组 & 干预措施
acupuncture
BL33 and BL35 of both sides are used. Every session will last for 30 minuets and will be given every other day. There are 36 sessions for each participant in all (3 session per week, 12 weeks).
干预措施: acupuncture (Procedure)
Solifenacin plus PFMT
Both PFMT and solifenacin will be given for 36 weeks. Solifenacin will be taken 5mg once daily, before or after meal. PFMT includes intensive exercises conducted in hospital and home exercises. Intensive exercises will be done once every week for the first 12 weeks and once every four weeks for the 13th to 36th week. Home exercises will be done three times daily for 36 weeks.
干预措施: solifenacin (Drug)
Solifenacin plus PFMT
Both PFMT and solifenacin will be given for 36 weeks. Solifenacin will be taken 5mg once daily, before or after meal. PFMT includes intensive exercises conducted in hospital and home exercises. Intensive exercises will be done once every week for the first 12 weeks and once every four weeks for the 13th to 36th week. Home exercises will be done three times daily for 36 weeks.
干预措施: PFMT (Procedure)
结局指标
主要结局
Percentage of Change From Baseline in 72-hour Incontinence Episode Frequency (IEF) Over Weeks 1-12
时间窗: baseline, weeks 1-12
The average 72-h IEF is calculated based on a 72-h bladder diary. All relevant time points used in the calculation in the Time Frame (baseline, weeks 1-12)
次要结局
- Percentage of Participants With ≥50% Decrease in Average 72-h Incontinence Episode Frequency(Weeks 1-12, 13-24, 25-36)
- the Amount of Urine Leakage (Grams) Measured by the 1-hour Pad Test at Weeks 4 and 12(Weeks 4 and 12)
- Percentage of Change From Baseline in Mean 72-hour IEF During Weeks 13-24 and Weeks 25-36(baseline, weeks 13-24, week 25-36)
- Change of Episodes From Baseline in Average 72-hour Urgencies/Urination/Nocturia Episodes(Baseline, weeks 1-12, 13-24, 25-36)
- Change From Baseline in the International Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF) Score(baseline, weeks 12, 24 and 36)
- Weekly Median Number of Urine Pads Used During Weeks 1-12, 13-24, and 25-36(Baseline, weeks 1-12, 13-24, 25-36)
- The Number of Participants Using Urine Pads(Weeks 1-12, 13-24, 25-36)
- Change of Episodes From Baseline in Mean 72-h Incontinence Episodes(Weeks 1-12, 13-24, 25-36)
- Patient Global Impression Improvement(Weeks 12, 36)
- Patient's Treatment Satisfaction Degree(Weeks 12, 36)
- Electroacupuncture Acceptance Assessment(Weeks 2, 6 and 12)
研究者
Liu Zhishun
Dean of Acupuncture Department of Guangan'men Hospital
Guang'anmen Hospital of China Academy of Chinese Medical Sciences