Outcome measure | Time frame | Description | Statistics | |
---|---|---|---|---|
Primary outcome | Proportion of change from baseline in 72-h IEF over week1-12 | Week 1-12 | The average 72-h IEF is calculated based on a 72-h bladder diary. The average 72-h IEF of week 1-12 is calculated by averaging the IEF of week 2, 4, 6, 8, 10, 12. | Covariance analysis or nonparametric test |
Secondary outcome | Proportion of change from baseline in 72-h IEF | Week 13–36, week 1–4, week 5–8, week 9–12, week 13–24, week 25–36 | Calculated as the same way as the primary outcome. But this outcome will be assessed at different time point. | A t test or nonparametric test |
Proportion of participants with ≥50% decrease in average 72-h IEF | Week 1–12, 13–24, 13–36 | Count the number of cases with the reduction of average 72-h incontinence episode frequency ≥50% and divide t by the number of participants at baseline. | A chi-square test or nonparametric test | |
Change from baseline in 72-h IEF | Week 1–12, 13–24, 13–36 | The average 72-h IEF (urinary incontinence, stress urinary incontinence and urgency urinary incontinence respectively) is calculated based on a 72-h bladder diary. For example, the average 72-h incontinence episodes from the 13th to 36th week equal to the sum of 72-h incontinence episodes of the 16th, 20th, 24th, 28th, 32nd, 36th weeks divided by 6. | A t test or nonparametric test | |
Change from baseline in the International Consultation on Incontinence Questionnaire-Short Form score | Baseline, week 1–12, 13–36 | The score of week 1–12 equals to the sum score of week 4, 8, 12 divided by 3. | A t test or nonparametric test | |
Change from baseline in the amount of urine leakage | Baseline, week 4, week 12 | The amount of urine leakage was tested by 1-h pad test. | A t test or nonparametric test | |
Change from baseline in average 72-h urgencies/urination/nocturia episodes | Baseline, week 1–12, 13-36 | The average 72-h urgencies/urination/nocturia episodes within a period equal to the sum of urgencies/urination/nocturia episodes (counted according to the urinary diary) divided by the number of weeks recorded. | A t test or nonparametric test | |
Change from the baseline in the number of pads used in one week | Baseline, week 1–12, 13–36 | The mean of pads used in one week equals to the sum of pad used in a period divided by the number of weeks within this period. | A t test or nonparametric test | |
Proportion of change from the baseline in 72-h IEF of subgroups | Week 1–12, 13–36 | Stratified by incontinence severity/types of mixed urinary incontinence/age at the baseline, the percent of change in 72-h incontinence episode frequency will be analyzed. | A covariance analysis or nonparametric test | |
Satisfaction degree | Week 12, 36 | A questionnaire will be done by participants to evaluate whether they are satisfied with the treatment | A chi-square test or nonparametric test | |
Patient global impression improvement | Week 12, 36 | Participants will be asked to finish one item evaluating their present condition. | A chi-square test or nonparametric test | |
Electroacupuncture acceptance assessment | Treatment session 1, 18, 36 | After the 1st, 18th and 36th session, the acceptance of electroacupuncture will be tested within 5 minute with a 5-point scale (‘0’ means very difficult to accept and ‘4’ means accept easily). Mean of scores of the three times will be calculated. | A chi-square test or nonparametric test |