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Table 1 Outcome measures

From: Effect of electroacupuncture versus pelvic floor muscle training plus solifenacin for moderate and severe mixed urinary incontinence in women: a study protocol

 

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