Table 2 Appendix.
Per-Protocol Between Group Comparisons: Median UUIa Episodes on 3 day diary & Percent
Hypnotherapy Median UUI Episodes on 3 day diary (Q1,Q3) Median % Change (95% CI)b | Pharmacotherapy Median UUI Episodes on 3 day diary (Q1,Q3) Median % Change (95% CI)b | Median Difference in % Change Between Groupsc,d(95% CI) | Meets Non-Inferiority Criteriae(95% CI Lower Bound > − 5%)e | |
---|---|---|---|---|
Change Between Groups | ||||
Baseline UUI (N=142) Median UUI Episodes (Q1,Q3) | N=67 8 (4, 12.5) | N=61 7 (4, 11) | Not Applicable | Not Applicable |
2 months UUI (N=128) Median UUI Episodes (Q1,Q3) Median % Change UUI episodes (95% CI) | N=67 1 (0, 5) 75.0% (62.5% to 88.9%) | N=61 1 (0, 3) 88.9% (83.3% to 100.0%) | 0% (−2.0% to 1.0%) | YES |
6 months UUI (N=109) Median UUI Episodes (Q1,Q3) Median % Change UUI episodes (95% CI) | N=54 1 (0, 3) 93.7% (81.8% to 100.0%) | N=55 1 (0, 4) 83.3% (64.7% to 100.0%) | −2.0% (−4.0% to 0.0%) | YES |
12 months UUI (N=100) Median UUI Episodes (Q1,Q3) Median % Change UUI episodes (95% CI) | N=53 1 (0, 3) 85.7% (66.7% to 93.8%) | N=47 1 (0, 5.5) 87.5% (54.5% to 100.0%) | −2.0% (−4.0% to 1.0%) | YES |
Urgency Urinary Incontinence
CI=Confidence Interval. Exact Mann-Whitney test used to account for skewed data with many tied values
All within group changes relative to baseline for Exact Test confidence intervals. Hodges-Lehmann estimate of differences between groups can differ from differences between group medians.
Median difference in % change= Hypnotherapy % change – Medication % change
Lower bound (i.e. smaller number of 95% CI) of difference in Hypnotherapy % change – Medication % change must be >− 5% to meet the non-inferiority criteria. For example, −6% for the lower bound would mean that hypnotherapy did not meet the non-inferiority criteria; −4.9% would mean that hypnotherapy did meet the non-inferiority criteria