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Key words: Black - Health-related quality of life - Overactive bladder - Patient-reported outcomes - Quality of life - Solifenacin - Symptom bother
ABSTRACT
Objective: Health-related quality of life (HRQoL) data for black patients receiving overactive bladder (OAB) treatment have not been previously reported. This study presents patient-reported outcomes, measured by symptom bother and HRQoL, in black patients participating in an open-label study of solifenacin succinate. Results are presented, as are those from the full study population.
Methods: In the 12-week, VESIcare Open-Label Trial (VOLT), patients received solifenacin 5mg or 10mg once daily according to an individualized, flexible-dosing regimen. A post-hoc analysis assessed solifenacin efficacy and safety in blacks (n=274). Three patient-derived indices served as study endpoints. The Patient Perception of Bladder Condition (PPBC) scale assessed overall symptom bother, a visual analog scale (VAS) recorded individual symptom bother, the Overactive Bladder Questionnaire (OAB-q) measured OAB-related HRQoL.
Results: Blacks reported significant reductions in bladder-related problems based on PPBC scores (p < 0.001) and improvements in all OAB-q subscales (symptom severity, coping, concern, sleep, social, and HRQoL; p < 0.001). Based on VAS ratings, significant improvements were reported for urinary urgency, urge incontinence, frequency, and nocturia (p < 0.001 for change from baseline). Although this study was not placebo-controlled and statistical comparisons were not made, results were similar in the full study population. In total, 46% of black patients experienced adverse events (mostly anticholinergic) and 7.6% discontinued treatment as a result.
Conclusions: Solifenacin treatment was perceived as offering relief from symptom bother and improving HRQoL in the black cohort from VOLT. These results are similar to those in the full VOLT population.
Introduction
Overactive bladder (OAB) is used to describe a collection of symptoms composed of urinary urgency, with or without urge urinary incontinence, and usually with increased daytime frequency and nocturia1,2. Studies have shown that the symptoms, as well as the coping strategies associated with OAB, impair daily functioning and reduce quality of life (QoL)3. It is estimated that OAB affects approximately 33 million people in the United States, making it more prevalent than asthma, osteoporosis, diabetes mellitus, or Alzheimer's disease4.
Prevalence rates vary significantly across studies. It should be noted that some differences may be related to differences in the definition of OAB...