Solifenacin treatment for overactive bladder in black patients: patient-reported symptom bother and health-related quality of life outcomes.
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.
Mallett
Veronica
V
University of Tennessee Health Science Center, Memphis, TN 38163, USA. vmallett@utmem.edu <vmallett@utmem.edu>
Burks
David
D
Garely
Alan D
AD
Smith
Neila
N
D000293:Adolescent; D000328:Adult; D001741:Black or African American; D000368:Aged; D000369:Aged, 80 and over; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D018727:Muscarinic Antagonists / Q000009:adverse effects / Q000627:therapeutic use; D011788:Quality of Life; D011812:Quinuclidines / Q000009:adverse effects / Q000627:therapeutic use*; D000069464:Solifenacin Succinate; D044005:Tetrahydroisoquinolines / Q000009:adverse effects / Q000627:therapeutic use*; D016896:Treatment Outcome; D053201:Urinary Bladder, Overactive / Q000188:drug therapy* / Q000523:psychology
D018727:Muscarinic Antagonists; D011812:Quinuclidines; D044005:Tetrahydroisoquinolines; D000069464:Solifenacin Succinate