Table 1 Outcome measures
Outcome measure | Time point | Description | Statistics | |
|---|---|---|---|---|
Primary outcome | Change in OABSS from baseline to the end of week 12 | Week 12 | Calculated based on the OABSS. | Modified t-test |
Secondary outcomes | Change in OABSS from baseline to the end of weeks 4, 8, 20, and 32 | Weeks 4, 8, 20, and 32 | Calculated in the same way as the primary outcome. | Covariance analysis or non-parametric test |
Proportion of participants with a decrease in the OABSS of ≥3 | Weeks 4, 8, 12, 20, and 32 | The number of patients with a reduction in OABSS ≥3 divided by the number of participants at baseline. | A chi-square test or Fisher’s test | |
Change in 24 h urination/nocturia/urgency urinary incontinence /urgency episodes from baseline | Weeks 4, 8, 12, 20, and 32 | The average 24 h urination/nocturia/urgency urinary incontinence /urgency episodes equal to the sum of urination/nocturia/urgency urinary incontinence/urgency episodes divided by 7. | Covariance analysis or non-parametric test | |
Change in OABSS for each question from baseline | Weeks 4, 8, 12, 20, and 32 | Calculated based on the OABSS for each question. | Covariance analysis or Non-parametric test | |
Change in OAB-q from baseline | Weeks 4, 8, 12, 20, and 32 | Calculated based on the OAB-q. | Covariance analysis or non-parametric test | |
Descriptive analysis of emergency medications and other treatments and drugs used at baseline, during therapy and at follow-up. | A questionnaire will be completed by participants to collect information regarding their other treatments. | Descriptive statistics | ||
Evaluation of the blinding of acupuncture | Week 12 | After the last treatment, the evaluation for the blinding of acupuncture will be tested within 5 min in the EA and SA groups | Descriptive statistics | |
EA acceptance assessment | Week 12 | After the last treatment, the acceptance of EA will be tested within 5 min with a 5-point scale (‘1’ indicates easily accept and ‘5’ indicates very difficult to accept). Average scores will be calculated. | A chi-square test or Fisher’s test | |
Evaluation of the intervention expectation | Weeks 0 and 12 | A questionnaire will be completed by participants to evaluate their expectations of the intervention. | A chi-square test or Fisher’s test |