Evaluation of Integrated Optimization Schemes for Female Stress Incontinence
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 358
- 试验地点
- 4
- 主要终点
- The change of urine loss
研究概览
简要总结
The aim of this study is to determine the effectiveness of PFMT added to EA vs PFMT added sham EA for SUI in women.
详细描述
We will perform a multicenter, randomized, double-blind, sham-controlled, parallel-group clinical trial in four hospitals in China to compare the effectiveness of EA added to PFMT vs sham EA added to PFMT for women with SUI.
The participated women with SUI will be recruited from four participating hospitals or through community clinics by advertising. Participated hospitals include: Yueyang Hospital of Integrated Traditional Chinese and Western Medicine Affiliated to Shanghai University of Traditional Chinese Medicine (Shanghai, China); Shaanxi Hospital of Traditional Chinese Medicine (Xi'an, China); First Teaching Hospital of Tianjin University of Traditional Chinese Medicine (Tianjin, China); and Nanjing Hospital of Chinese Medicine Affiliated to Nanjing University of Chinese Medicine (Nanjing, China).
Patients will be screened for eligibility. Chief complaint, medical history, and general characteristics (such as age, race, education level, body mass index, manner of child delivery, menopause) will be obtained. Those who met inclusion criteria and are interested in participating in the study will sign an informed consent form and then make another appointment to complete the baseline data collection, including the 72-hr bladder diary, 1-h pad test, International Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF) score, the weekly mean number of urine pads used). Participants will then be assigned randomly to either a PFMT (3 sets/day for 8 weeks) + EA (3 times per week for 8 weeks) group or a PFMT + sham EA group. The primary and secondary outcome will be measured from week 2 to 32. The participant-reported severity of UI and subjective self-evaluation of therapeutic effects will be recorded. Written informed consent will be obtained from all participants before they are included in the study. All clinical investigations will be conducted according to the principles of the Declaration of Helsinki.
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)
盲法说明
A central randomized system of clinical research (provided by the Clinical Evaluation Center of the Chinese Academy of Traditional Chinese Medicine) will be used for randomization. When eligible subjects are enrolled, randomized personnel from each center will log on to the central random online system to apply for a randomized number. Then the participants will be randomly assigned to PFMT+EA group or PFMT+sham EA group at a ratio of 1:1 to one of four hospitals. The following individuals in the trial will be blinded: 1) participants, this will be achieved by using sham EA procedure; (2) Evaluators, evaluation and record of measurements will be conducted by the evaluators who do not know the grouping situation; (3) Statisticians, group allocation will not be revealed until the statistical analyses are completed.
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
- •Women who are 40-75 years of age
- •Involuntary leakage of urine during increased intra-abdominal pressure in the absence of a bladder contraction, such as coughing, sneezing, or other physical activities
- •a 1-hour pad test exceeds 1 g
- •no other treatments are administered for urinary incontinence currently
排除标准
- •Subject has urgency and mixed urinary
- •Subjects with pelvic organ prolapse, pregnancy, a history of pelvic surgery, chronic respiratory diseases, urinary tract infection, cardiac pacemaker installation, metal allergy, severe needle fear, and currently taking medications for SUI or psychological disorders.
结局指标
主要结局
The change of urine loss
时间窗: The evaluation will be performed when the participants are first distributed into the groups as a baseline, and then at weeks 2, 4, 6 and 8 of treatment.
The change of urine loss is measured by the 1-hour urine pad test. The 1-hour pad test will be performed as follows: 1) Empty the bladder and wear a preweighted pad. 2) Drink 500 ml of sodium-free liquid in 15 minutes; 3) walk for half hours, including going up and down stairs; 4) perform the following activity in the remaining 30 minutes: squat and stand up 10 times; cough hard 10 times; run in place for 1 minute; bend down to pick up a small object on the ground 5 times; wash hands for 1 minute with running water. 5) Weigh the pad again to calculate the urine leakage (1 gram equivalent to 1 ml of urine).
次要结局
- Incidence of adverse events(the 1-8 weeks)
- severity of urinary incontinence(weeks 2, 4, 6, and 8)
- Participants using urine pads(week 2-8, week 17-20, week 29-32)
- Subjective self-evaluation of therapeutic effects(week 2, week 4, week 6, week 8, week 20, week 32)
- The average 24-hour urinary incontinence episodes and reduction of more than 50%(The average 24-hour urinary incontinence episodes and reduction of more than 50% at weeks 2, 4, 6, and 8 of treatment measured by a urinary diary. Reduction more than 50% in urine leakage at week 8 from baseline measured by the 1-hour pad test.)
- The International Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF) scores(The evaluation will be performed at baseline, weeks 4, 6, 8 of treatment, and weeks 20 and 32 of follow-up.)