Table 2.
Analyses of treatment effectiveness on patient reported primary outcome and secondary outcomes
| Intervention | Usual care | Adjusted analysis* | |||||||
|---|---|---|---|---|---|---|---|---|---|
| No† | Mean (SD) (min-max) | No† | Mean (SD) (min-max) | Difference (95% CI); P value | No analysed | ICC (95% CI) | |||
| Primary outcome | |||||||||
| IPSS: 12 months‡ | 442 | 11.6 (6.2) (1-35) | 473 | 13.9 (6.8) (0-32) | −1.81 (−2.66 to −0.95); <0.001 | 887 | 0.011 (0.001 to 0.086) | ||
| Secondary outcomes | |||||||||
| IPSS (range 0-35): | |||||||||
| 6 months‡ | 471 | 11.5 (6.1) (1-35) | 501 | 13.8 (6.6) (1-32) | −1.68 (−2.34 to −1.02); <0.001 | 942 | <0.001 (<0.001 to <0.001) | ||
| 6 and 12 months (repeated measures analysis)§ | 913 | 11.6 (6.2) (1-35) | 974 | 13.8 (6.7) (0-32) | −1.70 (−2.35 to −1.05); <0.001 | 1829 | 0.005 (0.0002 to 0.115) | ||
| ICIQ-UI-SF score (range 0-21): | |||||||||
| 6 months‡ | 476 | 3.6 (3.5) (0-15) | 504 | 4.5 (4.1) (0-20) | −0.53 (−1.02 to −0.04); 0.04 | 961 | 0.022 (0.007 to 0.072) | ||
| 12 months‡ | 453 | 3.7 (3.6) (0-18) | 480 | 4.5 (4.1) (0-18) | −0.74 (−1.15 to −0.33); <0.001 | 915 | <0.001 (<0.001 to <0.001) | ||
| IPSS quality of life score (range 0-6): | |||||||||
| 6 months‡ | 483 | 3.0 (1.2) (0-6) | 511 | 3.35 (1.25) (0-6) | −0.29 (−0.43 to −0.15); <0.001 | 984 | NE | ||
| 12 months‡ | 463 | 2.9 (1.3) (0-6) | 483 | 3.3 (1.25) (0-6) | −0.34 (−0.50 to −0.18); <0.001 | 937 | 0.004 (<0.001 to 0.274) | ||
| B-IPQ score (range 0-90): | |||||||||
| 6 months‡ | 450 | 33.4 (11.9) (2-73) | 430 | 38.3 (11.5) (1-76) | −5.34 (−6.69 to −3.99); <0.001 | 777 | <0.001 (<0.001 to <0.001) | ||
| 12 months‡ | 419 | 33.8 (12.0) (0-69) | 427 | 38.4 (12.2) (0-71) | −4.78 (−6.31 to −3.25); <0.001 | 746 | NE | ||
B-IPQ=Brief Illness Perception Questionnaire; ICC=intraclass correlation; CI=confidence interval; ICIQ-UI-SF=International Consultation on Incontinence Questionnaire Urinary Incontinence-Short Form; IPSS=International Prostate Symptom Score; NE=not estimable; SD=standard deviation.
Higher scores for IPSS, ICIQ-UI-SF, IPSS quality of life, and B-IPQ reflect more severe symptoms, greater impact on quality of life, or participants’ poorer perception of their LUTS.
Adjusted for baseline scores and minimisation variables.
Number of participants in each arm providing non-missing outcome data except in repeated measures analysis of IPSS (six and 12 months) where this reflects the number of repeated measures of IPSS in each arm.
Analysed using mixed effect multilevel linear model (individuals (level 1) nested within general practices (level 2)) adjusting for individual level baseline outcome measure and practice level variables used in the randomisation.
Analysed using a repeated measures linear mixed model (IPSS at six and 12 months (level 1), nested within participants (level 2) and nested within general practices (level 3)) adjusting for individual level baseline IPSS and practice level variables used in the randomisation.