67th Annual Meeting Abstracts

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Solifenacin Significantly Improves Symptom Bother In Patients With Overactive Bladder
*Michael Vardy¹, *H David Mitcheson², *Terri−Ann Samuels¹, *Tom Marshall³, *Sergio Forero-Schwanhaeuser⁴, *Weizhong He^5
1Mt. Sinai School of Medicine, New York, NY;²Bay State Clinical Trials, Inc., Watertown, MA;³Astellas Pharma US, Inc., Deerfield, IL;⁴GlaxoSmithKline, King of Prussia, PA;⁵Astellas Pharma Global Development, Inc., Deerfield, IL

Introduction: To assess the efficacy of solifenacin on symptom bother, health-related quality of life (HRQL), and overactive bladder (OAB) symptoms in patients with OAB using the Overactive Bladder Questionnaire (OAB-q) and bladder diaries.
Materials & Methods: Patients with OAB for ≥3 months were randomized to flexibly dosed (5 or 10 mg) solifenacin or placebo for 12 weeks. At baseline and at 4-week intervals, patients completed the OAB-q (Symptom Bother and HRQL) and 3-day bladder diaries. The primary efficacy variable was mean change from baseline to Week 12 in Symptom Bother score. Secondary variables included changes in HRQL and OAB symptoms.
Results: At Weeks 4, 8, and 12, solifenacin significantly reduced mean Symptom Bother score versus placebo as well as all HRQL domains and all OAB symptoms except nocturia versus placebo. Expected treatment-related adverse events in solifenacin versus placebo patients included dry mouth (13% versus 2%), constipation (8% versus 2%), dry eye (2% vs <1%), and blurred vision (1% versus 1%).

Table 1. Summary of results for OAB-q and bladder diary variables
	Mean at Baseline			Mean Change From Baseline to W12
OAB-q scale Domain	Placebo (n=374)	Solifenacin (n=377)		Placebo (n=374)	Solifenacin (n=377)	P-Value†
Symptom Bother*	57.9	58.2		-20.4	-29.9	<0.0001
Total HRQL (all 4 domains)	57.8	56.4		16.7	25.3	<0.0001
Coping	53.7	52.2		18.6	28.5	<0.0001
Concern	52.0	51.9		19.3	29.2	<0.0001
Sleep	51.3	47.3		17.4	26.6	<0.0001
Social Interaction	78.9	78.7		9.3	13.6	<0.0001
Bladder diary variable
Urgency*	5.7	5.7		-1.84	-3.05	<0.0001
Frequency*	11.9	11.7		-1.36	-2.23	<0.0001
Incontinence*	2.8	2.9		-1.24	-1.85	0.0024
Nocturia*	1.6	1.7		-0.48	-0.63	0.3408
*A negative value indicates improvement. †Based on ANCOVA model including terms for treatment, pooled center, and baseline value.

Conclusions: As early as Week 4 and through Week 12, flexibly dosed solifenacin significantly improved symptom bother and HRQL, as well as urgency, frequency, and incontinence compared with placebo. Solifenacin was well tolerated.

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