Table 2 Trial outcomes
Primary outcome | Time point |
|---|---|
Change in amount of urine leakage at week 6 from the baseline measured by 1-h pad test | Evaluated at week 6 |
Secondary outcomes | |
1. 72-h IEF | Evaluated at weeks 6, 18, and 30. The change of average 72-h IEF from the baseline will be analyzed |
Based on a 72-h bladder diary, the average 72-h IEF of week 6 is calculated by averaging the IEF of weeks 2, 4, and 6; values of week 18 and 30 are calculated by averaging IEF of weeks 15–18 and 27–30, respectively | |
2. ICIQ-UI Short Form score | Evaluated at weeks 6, 18, and 30. The change of score from the baseline will be analyzed |
3. Severity of urinary incontinence | Evaluated at weeks 6, 18, and 30. Change in the number and percentage of severity rating from the baseline will be analyzed |
The most severe degree during weeks 2, 4, and 6 will be taken as severity of urinary incontinence of week 6 | |
The most severe degree during weeks 15–18 and weeks 27–30 will be taken as severity of urinary incontinence of week 18 and week 30, respectively | |
4. Self-report assessment of therapeutic effect | Evaluated at weeks 6, 18, and 30 |
A 4-point scale is used: no help, little help, medium help, and great help | |
5. Weekly consumption of pads | Evaluated at weeks 6, 18, and 30. The change in average consumption of pads from the baseline will be analyzed |
The pads consumption of weeks 6, 18, and 30 will be calculated by averaging the weekly usage of pads during weeks 1–6, weeks 7–18, and weeks 19–30, respectively | |
6. Application of other treatment for SUI (including drugs and other specialist treatment) | Evaluated at weeks 6, 18, and 30. The number of patients who used other treatments for SUI during the trial will be analyzed between the two groups |
7. Subgroup analysis stratified by incontinence severity | Evaluated at weeks 6, 18, and 30 |
Stratified by incontinence severity at the baseline, the correlation between the rating of incontinence severity and the treatment effect will be analyzed. Different outcomes of treatment effect are used in each evaluation: week 6, the change in amount of urine leakage at week 6 from the baseline measured by 1-h pad test; week 18, the change of average 72-h IEF at week 18 from the baseline; and week 30, the change of average 72-h IEF at week 30 from the baseline |