Differences in change from baseline between the intervention group and control group for the three post baseline assessments will be evaluated by means of generalized estimating equations (GEE) for longitudinal analysis[ 36].
In addition to the fixed effects for time, treatment, time by treatment and baseline value, covariates at baseline identified as statistically different among the three groups and covariates known or hypothesised to be associated with the particular change from baseline outcome will be evaluated as fixed effects.
At baseline, eligible patients will be evaluated for demographic information, smoking, alcohol drinking status, biochemical data, dialysis variables, concomitant medications, and personal and family disease history.
PVR changes from baseline to 12 weeks will be evaluated because PVR increases when bladder outlet function is incomplete.
For outcomes measured on a continuous scale, differences between groups in the mean change from the baseline to 12 months will be evaluated using the linear mixed modeling.
For outcomes measured on a continuous scale, differences in mean change from baseline to 12 weeks between groups will be evaluated using linear regression modelling while adjusting for baseline levels of the outcome measure.
Baseline comparability between the two treatment groups will be evaluated with respect to disease characteristics, demographics and baseline values of self-report measures.
Both groups will be evaluated at baseline and at 4, 12 and 24 weeks of treatment.
All patients enrolled in the trial will be evaluated at baseline, 6, 12 and 18 months.
All patients will be evaluated at baseline, 6, 12 and 18 months.
