| Methods |
RCT. Placebo controlled, parallel design.
Phase II.
Double‐blind.
Masking of assessors not stated.
Multicentre. |
| Participants |
1081 male and female patients.
Inclusion criteria: Age more than18 years; DI more than 3 months; >8 voids/24 hours for 3 days; 5‐50 episodes of incontinence or urgency during 1 week,urgency 1 episode/24 hours
Exclusion criteria: BladderOutlet obstruction symptoms stabilized over 6 months, pregnancy,Post void residual >200ml; contra indications to anticholinergics, Hypersensitivity to drug |
| Interventions |
Group 1: solifenacin 5 mg (n = 266)
Group 2: solifenacin 10 mg (n = 264)
Group 3: tolterodine 2mg (n= 250)
Group 4: placebo (n= 253)
12 week treatment period.
2 week run in. |
| Outcomes |
Using electronic diaries, Change in baseline in mean number of micturition per 24 hours. Change from baseline in mean number of urgency episodes, Change in urge incontinence and volume voided per micturition.
Adverse events.
Laboratory tests.
ECG.
Blood pressure. |
| Notes |
Women committed to use of contraceptives during pregnancy were recruited
Bladder training not allowed during study, Concomitant use of drugs modifying liver enzymes not permitted. |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Allocation concealment? |
Low risk |
A ‐ Adequate |
