Millard 1999.

Methods	RCT. Placebo controlled, parallel design. Phase III. Randomised 1:2:2. Double‐blind. Masking of assessors not stated. ITT analysis. Multicentre. Multinational (2).
Participants	316 patients (male and female) Inclusion criteria: At least 18 years old, with cystometrically proved detrusor overactivity (idiopathic or hyper‐reflexia or contractions with an amplitude at least 10cm H2O); at least 8 voids/24 hours; at least 1 incontinent episode/24 hours and/or urinary urgency, Premenopausal women required to use adequate contraception. Excusion criteria: SI (cough test), clinically significant voiding difficulty, recurrent UTIs, interstitial cystitis, uninvestigated haematuria or any bladder cancer, indwelling catheter or self catheterisation, hepatic or renal disease, narrow angle glaucoma, electrostimulation or bladder training or anticholinergic drug initiated 14 days before or any time during study, unstable dose of any treatment with anticholinergic side effects, average total voided volume >3000ml/24 hours, treatment with any other investigational drug during or 2 months pre study.
Interventions	Group 1: placebo (n=64) Group 2: tolterodine 1mg bid (n=123) Group 3: tolterodine 2mg bid (n=129) 12 week treatment period. 2 week run‐in.
Outcomes	Cured incontinence and complete cure. Patient rating of bladder condition (6 point Likert). Leakage episodes, frequency of micturition. Achievement of normal voiding frequency (< 8/day) Adverse events. Laboratory tests. ECG. Blood pressure. Compliance by pill count.
Notes	No dose reductions permitted. 25 dropouts ( Group 1: 3, Group 2: 7; Group 3: 15) No follow up.
Risk of bias
Bias	Authors' judgement	Support for judgement
Allocation concealment?	Low risk	A ‐ Adequate