| Methods |
RCT. Placebo controlled, parallel design.
Phase III.
Randomised 2:2:1
Double‐blind.
Masking of assessors not stated.
ITT analysis.
Multicentre (42) Multinational (3). |
| Participants |
293 male and female patients.
Inclusion criteria: At least 18 years old with urodynamically confirmed OB, increased frequency of micturition (at least 8/24 hours) UI (at least 1/24 hours) and/or urgency
Exclusion criteria: Clinically significant SI, detrusor hyperreflexia, hepatic, renal or haemotological disorders, symptomatic or recurrent UTI, BOO, bladder training or electrostimulation therapy, indwelling catheter or self catheterisation, pregnant or breastfeeding or women not using reliable contraception. |
| Interventions |
Group 1: placebo (n=57)
Group 2: tolterodine 2mg bid (n=118)
Group 3: oxybutynin 5mg tid (n=118)
12 week treatment period.
1 week runin. |
| Outcomes |
Symptom questionnaire ( 6 point rating severity scale)
Number of leakage episodes, frequency of micturition, volume voided.
Adverse events.
Laboratory tests.
Blood pressure. |
| Notes |
Dose reduction to prevent withdrawal.
Two week follow up.
37 dropouts (Group 1: 7, Group 2: 10, Group 3: 20)
Company support declared. |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Allocation concealment? |
Low risk |
A ‐ Adequate |
