Outcomes | Time frame | Statistics |
---|---|---|
Primary outcome | ||
NIH-CPSI total score and change from baseline | baseline, week 1-8 | Covariance analysis or generalized estimating equations |
Secondary outcomes | ||
NIH-CPSI subscales score | Baseline, week 4,8,20,32 | Covariance analysis or generalized estimating equations |
NIH-CPSI total score in follow-up | week 20,32 | Covariance analysis or generalized estimating equations |
IPSS total score and change from baseline | baseline, week 4,8,20,32 | Covariance analysis or generalized estimating equations |
Global response assessment improvement | week 4,8,20,32 | CMH test or nonparametric test |
Degree of expectation | baseline | linear regress |
Degree of satisfaction | week 8,20,32 | CMH test or nonparametric test |