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 5 mg or 10 mg 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.