A Pilot Randomized Placebo Controlled Trial of Electroacupuncture for Women With Pure Stress Urinary Incontinence
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Change From Baseline of Urine Leakage Measured by 1-hour Pad Test
研究概览
简要总结
The purpose of this study is to preliminarily assess the efficacy of electroacupuncture (EA) for women with pure stress urinary incontinence (SUI).
详细描述
This was a pilot randomized, placebo controlled trial to preliminarily assess the efficacy of EA for women with pure SUI. Eligible participants were randomly assigned to EA group or sham EA group in a 1:1 ratio via a central randomization system by acupuncturists. Participants, outcome assessors and statisticians were blinded to treatment allocation. Subject blinding is achieved via the aid of adhesive pads used in both groups, placebo needle with a blunt tip and sham EA electrode lines. Assuming a two-sided alpha of 0.05, power of 90%, and a 20% drop-out, a sample size of 36 would be needed for each group. The investigators expanded the sample size to 80 cases (40 cases per group) to increase the reliability of the study. The investigators performed statistical analysis based on the intention-to-treat principle. All patients accepting randomization were included in the analysis. Missing data were filled in by the last observed value. Student t tests or Mann-Whitney U tests were used for the comparison of continuous variables; chi-square tests, Fisher's exact tests or Kruskal-Wallis H tests were used to compare categorical variables, as appropriate. For measures collected at two time points, paired t-tests or Wilcoxon signed rank tests were used as appropriate. A statistically significant difference was set at P<0.05.
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 (Participant, 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
- •Eligible women were 40 to 75 years of age, and met the clinical diagnosis recommendations of SUI by the International Consultation on Urological Diseases:
- •involuntary urine leakage on effort, exertion, sneezing or coughing which stopped when the stress ends;
- •visible involuntary leakage from the urethra synchronous with increased abdominal pressure, or a pad weight gain >1 g in 1-hour pad test;
- •without symptoms of urinary frequency and urgency.
排除标准
- •Women were excluded from the study if they met any of the following criteria: *other type of urinary incontinence (UI) (urge, mixed, or overflow UI, etc);
- •symptomatic urinary tract infection;
- •ever received UI or pelvic surgery;
- •a severity of pelvic organ prolapse ≥ degree 2;
- •residual urinary volume >30 ml;
- •maximum flow rate ≤ 20 ml/s;
- •limited in walking, stairs climbing and running;
- •receiving specialized treatment for SUI, or taking medicine affecting bladder function;
- •serious cardiovascular, cerebral, liver, kidney, or psychiatric disease, diabetes, multiple system atrophy, injury of cauda equina, or myeleterosis;
- •being pregnant or breastfeeding;
- •with cardiac pacemaker, metal allergy or severe needle phobia;
- •unlike to give written formed consent.
结局指标
主要结局
Change From Baseline of Urine Leakage Measured by 1-hour Pad Test
时间窗: Baseline and week 6
次要结局
- Patient Self-evaluation of Therapeutic Effect(weeks 6, 18 and 30)
- Change From Baseline of the Total ICIQ-SF Scores(Baseline, and weeks 6, 18 and 30)
- Change From Baseline of the 72-hour Incontinence Episode Frequency (IEF)(Baseline, weeks 1-6, weeks 15-18 and weeks 27-30)
研究者
huanfang xu
doctor
Guang'anmen Hospital of China Academy of Chinese Medical Sciences