Solifenacin is effective for the treatment of OAB dry patients: a pooled analysis.
OBJECTIVE
The aim of this analysis was to determine the effects of solifenacin in patients considered overactive bladder (OAB) dry at baseline.


METHODS
This was a pooled analysis of 4 randomized, placebo-controlled 12-week, phase 3 studies. Patients received placebo or solifenacin 10 mg once daily (2 studies), or placebo or solifenacin 5 mg or 10 mg once daily (2 studies). A subgroup of patients without incontinence at baseline was identified from a 3-day diary. Mean changes from baseline to endpoint for urgency episodes, micturition, frequency and nocturia episodes per 24 hours, and volume voided/micturition were evaluated. The proportion of patients with normalization of micturition frequency (<8 micturitions), resolution of urgency, or resolution of nocturia at endpoint was also determined.


RESULTS
Of 2848 evaluable patients treated with placebo or solifenacin, 975 (34%) were OAB dry at baseline. Solifenacin 5 mg and 10 mg were significantly (p < 0.001) more effective than placebo for improving urgency, micturition frequency, and volume voided. In addition, solifenacin 10mg was significantly (p < 0.01) more effective than placebo for improving nocturia. Resolution of urgency occurred significantly (p < 0.05) more often with solifenacin 5 mg (37%) and 10 mg (33%) than with placebo (25%). Significantly (p < 0.01) more OAB dry patients had normalization of micturition frequency with solifenacin 5 mg (29%) and 10 mg (35%) compared with placebo (19%). Resolution of nocturia occurred in 14%, 21%, and 13% of patients treated with solifenacin 5mg, solifenacin 10 mg, and placebo, respectively (p < 0.01 for solifenacin 10 mg versus placebo).


CONCLUSIONS
Solifenacin significantly improved urgency, frequency, and nocturia symptoms and increased volume voided in OAB dry patients.
Abrams
Paul
P
Bristol Urological Institute, Department of Urology, Southmead Hospital, UK. paul_abrams@bui.ac.uk
Swift
Steven
S
D000328:Adult; D017326:Clinical Trials, Phase III as Topic; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D011812:Quinuclidines / Q000008:administration & dosage / Q000627:therapeutic use*; D016032:Randomized Controlled Trials as Topic; D000069464:Solifenacin Succinate; D044005:Tetrahydroisoquinolines / Q000008:administration & dosage / Q000627:therapeutic use*; D016896:Treatment Outcome; D014549:Urinary Incontinence / Q000188:drug therapy*
D011812:Quinuclidines; D044005:Tetrahydroisoquinolines; D000069464:Solifenacin Succinate