Reductions in overactive bladder-related incontinence from pooled analysis of phase III trials evaluating treatment with solifenacin.
The embarrassment and social stigma associated with urinary incontinence (UI) in overactive bladder syndrome (OAB) sufferers is a major reason for individuals to seek help for their condition. An analysis of 1,873 subjects with OAB with UI was conducted to assess the efficacy of solifenacin in reducing incontinence in a pooled population from four phase III clinical trials, stratified by severity of incontinence, urgency, and other key factors at baseline. Subjects were randomized to either 5 or 10 mg of solifenacin once daily or placebo for 12 weeks. More than 50% of the total population became continent at study end, with either dose of solifenacin (P<0.01 vs placebo). Significant reductions in incontinence episodes and higher rates of attainment of continence vs placebo were observed irrespective of age or severity of incontinence or urgency at baseline with solifenacin treatment. Treatment was well tolerated, with the majority of adverse events being mild in nature. Solifenacin is an effective antimuscarinic agent for the treatment of incontinence associated with OAB.
Cardozo
Linda
L
Department of Urogynaecology, King's College Hospital, London, W1G 6HP, UK. lcardozo@compuserve.com
Castro-Diaz
David
D
Gittelman
Marc
M
Ridder
Arwin
A
Huang
Moses
M
D000328:Adult; D064420:Drug-Related Side Effects and Adverse Reactions; D005260:Female; D006801:Humans; D008297:Male; D018727:Muscarinic Antagonists / Q000009:adverse effects / Q000627:therapeutic use*; D011153:Population; 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*; D014549:Urinary Incontinence / Q000188:drug therapy*
D018727:Muscarinic Antagonists; D011812:Quinuclidines; D044005:Tetrahydroisoquinolines; D000069464:Solifenacin Succinate