| Methods |
RCT. Placebo controlled, parallel design.
Double‐blind.
Masking of assessors not stated.
Multicentre (58), Multinational(3). |
| Participants |
242 patients (male and female) Mean age 58.
Inclusion criteria: At least 18 years old with detrusor overactivity and evidence of frequency in combination with UI, urinary urgency or both.
Exclusion criteria: Significant stress incontinence, hepatic or renal disease, any condition contraindicating anticholinergic therapy, recurrent UTI's, interstitial cystitis, uninvestigated haematuria or clinically significant voiding difficulty with risk of urinary retention. Patients on any anticholinergic treatment or using an indwelling catheter or who had electrostimulation or bladder training in the 14 days prior to inclusion visit. |
| Interventions |
Group 1: placebo (n=44)
Group 2: tolterodine 1mg bid (n=99)
Group 3: tolterodine 2mg bid (n=99)
4 week treatment period.
2 week run‐in. |
| Outcomes |
Urodynamic parameters.
Adverse events.
Laboratory tests.
Blood pressure. |
| Notes |
10 dropouts (Group 1: 3, Group 2: 4, Group 3: 3)
No follow up. |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Allocation concealment? |
Low risk |
A ‐ Adequate |
