P A Wiseman1, J Malone-Lee, G S Rai. 1. Department of Geriatric Medicine, University College and Middlesex School of Medicine, University College Hospital, London.
Abstract
OBJECTIVE: To compare terodiline with bladder retraining against placebo with bladder retraining in the treatment of detrusor instability in frail elderly patients. DESIGN: Randomised, double blind, parallel group study. Treatment lasted for six weeks. Frequency of micturition and episodes of incontinence recorded on diary chart by patients. SETTING:Incontinence clinic and a geriatric day hospital at two teaching hospitals. PATIENTS: 37 frail but ambulant patients, mean (range) age 80.4 (70-89) years with urinary frequency and urge incontinence, due to detrusor instability. Two patients withdrew before the first assessment (one in each group) and one could not complete the diary chart (placebo group). INTERVENTIONS:19 patients receivedbladder retraining and terodiline 25 mg daily and 18 bladder retraining and placebo. MAIN OUTCOME MEASURES: Change in urinary frequency and number of episodes of incontinence after six weeks' treatment. Patient's subjective evaluation of symptoms. RESULTS: Little difference was found in the results of treatment with terodiline and placebo. The change in episodes of incontinence per 24 hours was no different in the two groups (95% confidence interval -0.6 to 1.2; p = 0.75) and the difference between treatments in the change in frequency of micturition per 24 hours (-0.2) was not significant (-1.1 to 1.2; p = 0.76). Ten patients taking terodiline thought they had improved compared with seven receiving placebo; this difference was not significant. CONCLUSION: Although the number of patients in each group was small and may have been insufficient to detect a drug effect, the possible benefit of terodiline is likely to be small.
RCT Entities:
OBJECTIVE: To compare terodiline with bladder retraining against placebo with bladder retraining in the treatment of detrusor instability in frail elderly patients. DESIGN: Randomised, double blind, parallel group study. Treatment lasted for six weeks. Frequency of micturition and episodes of incontinence recorded on diary chart by patients. SETTING:Incontinence clinic and a geriatric day hospital at two teaching hospitals. PATIENTS: 37 frail but ambulant patients, mean (range) age 80.4 (70-89) years with urinary frequency and urge incontinence, due to detrusor instability. Two patients withdrew before the first assessment (one in each group) and one could not complete the diary chart (placebo group). INTERVENTIONS: 19 patients received bladder retraining and terodiline 25 mg daily and 18 bladder retraining and placebo. MAIN OUTCOME MEASURES: Change in urinary frequency and number of episodes of incontinence after six weeks' treatment. Patient's subjective evaluation of symptoms. RESULTS: Little difference was found in the results of treatment with terodiline and placebo. The change in episodes of incontinence per 24 hours was no different in the two groups (95% confidence interval -0.6 to 1.2; p = 0.75) and the difference between treatments in the change in frequency of micturition per 24 hours (-0.2) was not significant (-1.1 to 1.2; p = 0.76). Ten patients taking terodiline thought they had improved compared with seven receiving placebo; this difference was not significant. CONCLUSION: Although the number of patients in each group was small and may have been insufficient to detect a drug effect, the possible benefit of terodiline is likely to be small.