Solifenacin treatment for overactive bladder in Hispanic patients: patient-reported symptom bother and quality of life outcomes from the VESIcare Open-Label Trial.
Author(s): Capo' JP Jr, Laramee C, Lucente V, Fakhoury A, Forero-Schwanhaeuser S
Affiliation(s): Internal Medicine Associates of Atlanta, Atlanta, GA 30342, USA. email@example.com
Publication date & source: 2008-01, Int J Clin Pract., 62(1):39-46. Epub 2007 Nov 23.
Publication type: Clinical Trial, Phase III; Multicenter Study; Research Support, Non-U.S. Gov't
OBJECTIVE: The primary goal of overactive bladder (OAB) treatment is to reduce symptoms and improve health-related quality of life (HRQoL). Although trials open enrolment to everyone, most OAB studies feature Caucasians. Here we present Hispanic data. METHODS: VESIcare Open-Label Trial was a 12-week, open-label, flexible-dosing study in patients with OAB symptoms for >or=3 months. All patients started on solifenacin 5 mg/day, with a dosing option of 5 or 10 mg/day at weeks 4 and 8. Three patient-reported outcome (PRO) measures assessed symptom improvement and treatment satisfaction: the Patient Perception of Bladder Condition (PPBC) scale, a Visual Analogue Scale (VAS), the Overactive Bladder Questionnaire (OAB-q). RESULTS: 94/2205 patients in the full population were Hispanic. Urgency was most frequently reported at baseline (93.6%), followed by frequency (91.5%), nocturia (84.0%) and urge incontinence (UI) (67.0%). Frequency was reported as the most bothersome symptom (MBS) by a higher proportion of Hispanics than the full population (40.4% vs. 28.1%). UI was reported as the MBS by a smaller proportion of Hispanics (18.1% vs. 27.3%). Patients reporting moderate-to-severe problems related to bladder condition at baseline reported improvement to 'some minor problems' at week 12. Over 72.0% of patients experienced PPBC score improvement. Both groups reported significant improvements in urgency, UI, frequency and nocturia on the VAS (all p<0.001) and all OAB-q domains (all p<0.001) at week 12. CONCLUSION: Although numbers were small, Hispanics receiving solifenacin for OAB reported improvement from baseline in symptom bother and HRQoL, as assessed by three independent PRO measures.