Mattiasson 2009.

Methods	Multicentre, prospective, randomized, parallel‐group, open label study
Participants	N = 643 Men or women over 18 with OAB
Interventions	Flexible‐dose solifenacin 5/10 mg (323 participants) versus solifenacin + simplified bladder training (320 participants) At week 8, patients in both groups could request a dose increase to solifenacin 10 mg od for the remaining 8 weeks of the study
Outcomes	At 8 weeks using solifenacin 5 mg Mean number of micturitions/24h after 8 weeks = 9.32 versus 8.60 Change from baseline in micturitions/24h from baseline = ‐2.18 versus ‐2.87 Change from baseline in urgency from baseline = ‐1.99 versus ‐1.98 Change from baseline in urge incontinence episodes from baseline = ‐1.01 versus ‐1.16 Change in number of pads/24 from baseline = ‐1.19 versus ‐1.07 Change in patient perception of bladder condition from baseline = ‐1.24 versus ‐1.23 Change in treatment satisfaction VAS from baseline = 3.32 versus 3.50 Change in I‐QOL scores from baseline = 20.65 versus 19.68 At 16 weeks using solifenacin 5/10mg Mean number of micturitions/24h after 8 weeks = 9.32 versus 8.60 (SD not given) Change from baseline in micturitions/24h from baseline = ‐2.42 versus ‐3.11 Change from baseline in urgency from baseline = ‐2.20 versus ‐2.50 Change from baseline in urge incontinence episodes from baseline = ‐1.13 versus ‐1.38 Change in number of pads/24 from baseline = ‐1.29 versus ‐1.11 Change in patient perception of bladder condition from baseline = ‐1.58 versus ‐1.63 Change in treatment satisfaction VAS from baseline = 3.72 versus 4.18 Change in I‐QOL scores from baseline = 24.51 versus 25.34 Adverse effects solifenacin n = 323 versus solifenacin +simplified bladder training n = 320 Number experiencing adverse effects = 150 versus 149 Number withdrawing from treatment or trial arm = 19 versus 15 Number changing dose of treatment = 137 versus 125
Notes	81 centres in 16 countries in Europe and Australia
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	No mention in the paper
Allocation concealment (selection bias)	Unclear risk	No mention in the paper
Blinding (performance bias and detection bias) All outcomes	High risk	Open label. Investigator or research nurse reviewed the bladder diaries with the patient to ensure accuracy of completion
Incomplete outcome data (attrition bias) All outcomes	High risk	"Full analysis set included all patients randomised at baseline who took one or more doses of study medication and who provided primary efficacy data at baseline and week 4 or 8". Safety population included all patients who took at least one dose of study medication