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Report from a randomized, placebo-controlled study showing significant improvement in urgency and patient-reported outcomes in overactive bladder patients treated with solifenacin
David Staskin, MD1, Roger Dmochowski, MD2, Scott Serels3, Allam Fakhoury, MD4.
1Cornell University, New York, NY, USA, 2Department of Urologic Surgery and Vanderbilt Continence Center, Nashville, TN, USA, 3Bladder Control Center of Norwalk, Norwalk, CT, USA, 4Astellas Pharma US, Inc, Deerfield, IL, USA.
BACKGROUND: The International Continence Society placed urgency as the pivotal symptom in the latest definition of overactive bladder (OAB: urinary urgency, with/without urge incontinence, usually with urinary frequency and nocturia).1 The traditional goal of OAB treatment has been to reduce urinary symptoms, but recent literature highlight the value of patient-reported outcome (PRO) measures in assessing efficacy.2 VENUS (VESIcare Efficacy and Safety in PatieNts with Urgency Study) was one of the first studies with urgency episodes as the primary endpoint, and also assessed multiple urgency-related and overall OAB secondary endpoint measures including health-related quality of life (HRQoL).
METHODS: VENUS was a randomized, double-blind, multicenter, 12-week trial comparing solifenacin 5 and 10 mg daily vs placebo in OAB patients (n=739) with ≥1 urgency episode/day. Primary endpoint was the mean change from baseline to Week 12 in urgency episodes/day assessed by 3-day micturition diary (urgency defined as sudden compelling desire to urinate). Secondary endpoints were median change from baseline in warning time (WT; time between first sensation of urgency to voiding), and mean changes from baseline in the Indevus Urgency Severity Scale (IUSS), Urgency Perception Scale (UPS), Patient Perception of Bladder Condition (PPBC), and Overactive Bladder Questionnaire (OAB-q). All changes were assessed at 12 weeks.
RESULTS: Statistically significant improvements were observed for solifenacin vs placebo in urgency episodes (change from baseline to endpoint -3.91 for solifenacin vs -2.73 for placebo; P<0.0001) and median WT (change = 31.5 sec for solifenacin vs 12.0 sec for placebo; P=0.032). Significant improvements were also seen in urgency-related PRO measures (change in IUSS = -0.9 for solifenacin vs -0.5 for placebo, P<0.0001; change in UPS = 0.4 for solifenacin vs 0.2 for placebo, P=0.0018), and in the PPBC (change = -1.0 for solifenacin vs -0.6 for placebo, P<0.0001); as well as scales evaluating overall OAB impact on HRQoL (e.g. change from baseline to endpoint in the overall HRQoL subdomain = 22.6 for solifenacin vs 17.2 for placebo (P<0.001).
CONCLUSIONS: Solifenacin-treated patients had statistically significant improvements in objective and subjective measures of urgency and WT, and in overall HRQoL compared to placebo.
1. Chapple CR et al. BJU Int 2005;95;335-40.
2. Brubaker L et al. Urology 2006;68 (Suppl 2A):3-8.
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