Solifenacin treatment in men with overactive bladder: effects on symptoms and patient-reported outcomes.
OBJECTIVE
In the few studies to evaluate antimuscarinics for overactive bladder (OAB) in men, safety has been the primary focus. In OAB efficacy trials, subject populations have been predominantly female and patient-reported outcomes (PROs) have been assessed only recently. We present a post hoc analysis of PRO-based findings from the subset of men (without presumed bladder outlet obstruction [BOO]) from two large, independent, open-label trials of solifenacin.


METHODS
Subjects with OAB for > or =3 months received flexibly dosed solifenacin for 12 weeks. At baseline and 4-week intervals, subjects completed the Patient Perception of Bladder Condition (PPBC) and Overactive Bladder Questionnaire (OAB-q). In one study, subjects also completed 3-day bladder diaries. At baseline, mean PPBC scores were similar in both studies and indicative of moderate-to-severe problems.


RESULTS
After 12 weeks of solifenacin, mean PPBC scores improved significantly (p < 0.0001); values were suggestive of minor-to-moderate problems. Mean scores on the OAB-q were also significantly improved after solifenacin (p values < or =0.001). In men without presumed BOO, solifenacin significantly improved PRO measures of symptom bother, health-related quality of life, and overall perception of bladder problems.


CONCLUSIONS
Results from these two studies support the use of solifenacin as a well-tolerated and efficacious treatment option for providing symptom relief in men with OAB without BOO.
Kaplan
Steven A
SA
Department of Urology, Weill Cornell Medical College, New York, New York 10065, USA. kaplans@med.cornell.edu
Goldfischer
Evan R
ER
Steers
William D
WD
Gittelman
Marc
M
Andoh
Masakazu
M
Forero-Schwanhaeuser
Sergio
S
D000368:Aged; D006801:Humans; D008297:Male; D008875:Middle Aged; D018727:Muscarinic Antagonists / Q000009:adverse effects / Q000627:therapeutic use*; D017060:Patient Satisfaction; D011812:Quinuclidines / Q000009:adverse effects / Q000627:therapeutic use*; D012720:Severity of Illness Index; D000069464:Solifenacin Succinate; D044005:Tetrahydroisoquinolines / Q000009:adverse effects / Q000627:therapeutic use*; D016896:Treatment Outcome; D053201:Urinary Bladder, Overactive / Q000188:drug therapy*; D014554:Urination / Q000187:drug effects
D018727:Muscarinic Antagonists; D011812:Quinuclidines; D044005:Tetrahydroisoquinolines; D000069464:Solifenacin Succinate