| Methods |
RCT. Placebo controlled, parallel design.
Randomised 3:3:2.
Double‐blind.
Masking of assessors not stated.
ITT analysis.
Multicentre (26). Multinational (3). |
| Participants |
177 male and female patients.
Inclusion criteria: At least 65 years old with 8 or more voids per 24 hours and/or urge incontinence at least 1 per 24 hours.
Exclusion criteria: "standard". |
| Interventions |
Group 1: placebo (n=43)
Group 2: tolterodine 1mg bid (n=61)
Group 3: tolterodine 2mg bid (n=73)
4 week treatment period.
14 day run‐in. |
| Outcomes |
Number of leakage episodes, frequency of micturition, volume voided.
Adverse events.
Laboratory tests.
ECG.
Compliance by pill count. |
| Notes |
12 dropouts (Group 1: 1, Group 2: 4, Group 3: 7)
Two week follow up for adverse events. |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Allocation concealment? |
Low risk |
A ‐ Adequate |
