| Methods |
RCT. Placebo controlled, parallel design.
Stratified by type (urge, mixed) and whether incontinence mild, moderate or severe.
Randomisation within each stratum.
Assessors masked.
ITT analysis. |
| Participants |
197 female patients.
Inclusion criteria: community dwelling, ambulatory and at least 55 years of age. Urge incontinence at least twice per week and for at least 3 months. Urge incontinence to be the predominant pattern (number of urge accidents to exceed number of stress accidents). Urodynamic evidence of bladder dysfunction.
Exclusion criteria: continual leakage, postvoid residual >200 ml, uterine prolapse, narrow‐angle glaucoma, unstable angina, decompensated congestive heart failure, history of malignant arrhythmias, or impaired mental status (MMSE score <20) |
| Interventions |
Group 1: pelvic floor muscle training/behavioral training with or without biofeedback (n=65)
Group 2: oxybutynin 2.5‐5mg tid (n=67)
Group 3: placebo (n=65)
8 week treatment period. |
| Outcomes |
Patient satisfaction and perceptions of treatment. Leakage episodes.
Adverse events. |
| Notes |
Dose reduction allowed to prevent withdrawal.
28 dropouts (Group 1: 4, Group 2: 12, Group 3: 12)
No follow up.
Support from health research grant declared. |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Allocation concealment? |
Low risk |
A ‐ Adequate |
