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Randomized Controlled Trial
. 2008 Apr;62(4):606-13.
doi: 10.1111/j.1742-1241.2008.01714.x.

A comparison of the efficacy of darifenacin alone vs. darifenacin plus a Behavioural Modification Programme upon the symptoms of overactive bladder

M B Chancellor  1 , F Kianifard, E Beamer, L Mongay, U Ebinger, G Hicks, A Delconte
Affiliations
Randomized Controlled Trial

A comparison of the efficacy of darifenacin alone vs. darifenacin plus a Behavioural Modification Programme upon the symptoms of overactive bladder

M B Chancellor et al. Int J Clin Pract. 2008 Apr.

Abstract

Purpose: This study assessed the benefit of adding behavioural modification to darifenacin treatment for overactive bladder (OAB).

Materials and methods: The ABLE trial was a randomised, open-label, parallel-group, multicentre study of 12 weeks of darifenacin treatment [with voluntary up-titration from 7.5 mg once daily (qd) to 15 mg qd at week 2] alone or in combination with a Behavioural Modification Programme (BMP) for men and women with dry or wet OAB. Efficacy was assessed as the change in the number (per day) of micturitions (primary variable), urge urinary incontinence (UUI) episodes, urgency episodes, pads used and nocturnal voids. Health-related quality of life (HRQoL) was also evaluated. Tolerability and safety assessments included adverse events and the number of discontinuations.

Results: Of 592 patients screened, 395 were randomised, 190 to darifenacin alone and 205 to darifenacin + BMP. At baseline, the majority of subjects were dry (mean 2.8 and three UUI episodes per day in the darifenacin and darifenacin + BMP groups respectively). At study end, darifenacin alone and darifenacin + BMP both produced significant reductions from baseline in median numbers of micturitions, UUI episodes, urgency episodes and nocturnal voids (all p < 0.05), but not in the number of pads used. HRQoL also improved. There were no significant differences between treatment groups in efficacy or HRQoL variables.

Conclusions: Darifenacin treatment provides a degree of normalisation of micturition variables and improvement in HRQoL that cannot be further enhanced by behavioural therapy of the type used in this study. Whether behavioural modification would add benefit over darifenacin treatment in patients with more pronounced incontinence problems remains to be determined.

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Figures

Figure 1
Figure 1
A schematic of the study design. BMP, Behavioural Modification Programme. *3-day paper diary completed 1 week prior to clinic visit
Figure 2
Figure 2
Patient disposition and flow
Figure 3
Figure 3
Median change from baseline in average number of micturitions per day over the 12 weeks of treatment with darifenacin or darifenacin plus Behavioural Modification Programme (BMP) for the intent-to-treat (ITT) population. There was no significant difference between the responses to the two treatments at any of the assessment time points. *p < 0.05 vs. baseline
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