| Methods |
RCT. Placebo controlled, parallel group.
Phase III.
Double‐blind.
Masking of assessors not stated.
Multicentre, Multinational (4). |
| Participants |
251 male and female patients.
Inclusion criteria: Over 18 years old with urodynamically verified detrusor overactivity, symptoms of urinary frequency and either urge incontinence or urgency or both.
Exclusion criteria: SI, hepatic or renal disease, symptomatic or recurrent UTI, interstitial cystitis, haematuria, clinically significant voiding difficulty, patients receiving bladder training, electrostimulation, or having an indwelling catheter or intermittent catheterisation; pregnant or breastfeeding women or women of childbearing age who were not using reliable contraception. |
| Interventions |
Group 1: placebo (n=51)
Group 2: tolterodine 1mg bid (n=97)
Group 3: tolterodine 2mg bid (n=103)
4 week treatment period.
2 week run‐in. |
| Outcomes |
Number of leakage episodes, frequency of micturition, volume voided.
Adverse events.
Laboratory tests.
Blood pressure.
Compliance by pill count. |
| Notes |
6 dropouts (Group 1: 1, Group 2: 3, Group 3: 2)
2 week follow up.
Company support declared. |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Allocation concealment? |
Low risk |
A ‐ Adequate |
