Methods |
RCT. Placebo controlled, parallel design.
Randomised 2:1.
Double‐blind.
Masking of assessors not stated.
Multicentre.
Multinational. |
Participants |
221 male patients.
Inclusion criteria: Men over 40 years with urodynamically verified overactive bladder and mild, moderate or severe BOO.
Exclusion criteria: Concurrent treatment with 5alpha‐reductase inhibitors or alpha‐adrenergic antagonists, baseline postvoid residual >40% maximum cystometric capacity, prior prostate or bladder surgery. |
Interventions |
Group 1: tolterodine 2mg bid (n=149)
Group 2: placebo (n=72)
12 week treatment period. |
Outcomes |
Urodynamic parameters.
Adverse events. |
Notes |
Abstract.
28 dropouts (Group 1: 16, Group 2: 12).
No follow up. |
Risk of bias |
Bias |
Authors' judgement |
Support for judgement |
Allocation concealment? |
Low risk |
A ‐ Adequate |