A review of solifenacin in the treatment of urinary incontinence

Figures & data

Table 1 Clinical trials evaluating the efficacy of solifenacin in the treatment of overactive bladder

Clinical trial phase	Trial design	Duration (months)	Primary outcome measure	Secondary outcome measures	Quality of life assessment
2	Dose finding study. Randomized, single-blind placebo- and tolterodine-controlled trial.	2	Change from baseline to the last study visit in the number of voids/24 hours	Change in volume voided per void Incontinence, urgency per 24 hours Total sum score of Contilife questionnaire	Contilife questionnaire
3	2 studies 013, 014. Placebo-controlled trials assessing solifenacin 10 mg	3	Mean number micturition episodes/24 hours	Change from baseline in mean number of urgency, all incontinence, urge incontinence episodes	Nil
	Randomized, double-blind placebo- and tolterodine- controlled trial of solifenacin			Change from baseline in mean voided volume/void	Contilife questionnaire KHQ
	Randomized, double-blind, placebo-controlled trial solifenacin 5/10 mg				KHQ
Extension study	Open-label 1-year study of solifenacin 5 mg/10 mg in patients with OAB	12	Mean number of micturition episodes/24 hours	Urgency, incontinence, nocturia episodes/24 hours Volume voided per void Satisfaction with treatment Tolerability of treatment	KHQ
Head to head	Prospective, double-blind, study to compare the efficacy and safety of solifenacin 5/10 mg and tolterodine extended release; STAR trial	3	Mean number micturition episodes/24 hours	Urgency, urge incontinence, all incontinence, nocturia episodes. Pad test Number of patients requesting dose escalation	PBC
Post marketing	Prospective, double-blind, 2-arm study comparing the efficacy of placebo and solifenacin; SUNRISE – (preliminary data available)	4	PIUS questionnaire – score changes	Total urgency episodes/24 hours Urgency bother visual analogue scale Number of micturition episodes, incontinence episodes/24 hours Treatment satisfaction visual analogue scale	PBC Treatment satisfaction visual analogue scale Urgency bother visual analogue scale PIUS
Post marketing	Randomized, double-blind, placebo-controlled, parallel-group, flexible dosing study of solifenacin; VENUS – (preliminary data available)	3	Warning time, Change in number of urgency episodes/ 24 hours	Indevus urgency severity scale Urgency perception scale	Indevus urgency severity scale (IUSS) Urgency perception scale

Abbreviations: KHQ, Kings health questionnaire; PBC, perception of bladder condition.

Figure 1 Changes in bladder diary variables in a phase 2, solifenacin dose finding study.

Figure 2 Reduction from baseline in the number of micturition and urgency episodes in 24 hours, and episodes of nocturia in patients receiving placebo, 5 mg, or 10 mg of solifenacin in a phase 3 trial (drawn from data of Cardozo et al 2004).

Figure 3 The percentage change from baseline in the mean number of urgency, incontinence, and urge incontinence episodes and mean voids in a 24-hour period (Drawn from data of Chapple et al 2004b).

Figure 4 Design of the STAR study.

Figure 5 Median percentage reductions in frequency, urgency, and nocturia in long-term solifenacin treated patients. Reprinted with permission from Haab F, Cardozo L, Chapple C, et al. 2005. Long term open-label solifenacin treatment associated with persistence with therapy in patients with overactive bladder syndrome. Eur Urol, 47:376–84. Copyright © 2005 Elsevier.

Figure 6 Pooled changes from baseline in the KHQ domains for 2 of the phase 3 trials for solifenacin.

Figure 7 Changes from baseline in the KHQ domains for the open label solifenacin extension study.

CardozoLLisecMMillardRRandomized, double-blind placebo controlled trial of the once daily antimuscarinic agent solifenacin succinate in patients with overactive bladderJ Urol200417219192415540755

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ChappleCRechbergerTAl-ShukriSRandomized, double-blind placebo-and tolterodine-controlled trial of the once-daily antimuscarinic agent solifenacin in patients with symptomatic overactive bladderBJU Int2004933031014764127

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ChappleCRMartinez-GarciaRSelvaggiLA comparison of the efficacy and tolerability of solifenacin succinate and extended release tolterodine at treating overactive bladder syndrome: results of the STAR trialEur Urol2005484647015990220

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