Clinical Health Updates

Trospium chloride (Sanctura) effective for overactive bladder symptoms

Clinical Question:
Is trospium chloride effective and safe in the treatment of overactive bladder?

Bottom Line:
Trospium chloride (Sanctura) once daily provided significant improvements in overactive bladder symptoms (frequency, urgency urinary incontinence and urgency). Efficacy was similar to that seen previously with trospium chloride twice daily, while class effect anticholinergic adverse events occurred at comparatively low levels. Dry mouth was elicited at the lowest reported rate in the oral antimuscarinic drug class.

Reference:
Staskin D, Sand P, Zinner N, Dmochowski R; Trospium Study Group. Once daily trospium chloride is effective and well tolerated for the treatment of overactive bladder: Results from a multicenter phase III trial. J Urology 2007;178:978-984.

Study Design:
Randomized controlled trial (double-blinded)

Synopsis:
These investigators enrolled 601 patients meeting standard criteria for overactive bladder (frequency, urgency, and urinary incontinence). Patients randomly received (uncertain allocation concealment) 60 mg trospium chloride once daily or matched placebo. Study participants masked to treatment group assignment self-reported outcomes using a validated urinary urgency severity scale. Complete follow-up occurred for 98% of patients at 12 weeks. Using intention-to-treat analysis, patients assigned to the trospium group were more likely to achieve “normalization” (no urgency urinary incontinence episodes and a daily void frequency of 8 or less) than the placebo group (20.5% vs 11.3 %; number needed to treat = 11; 95% CI, 7-29). Although it is uncertain if the difference is clinically relevant, trospium-treated patients also reported significantly fewer urgency urinary incontinence episodes daily than the placebo group (mean = 1.6 vs 2.2). Adverse events occurring more often in the trospium group included dry mouth (8.7%) and constipation (9.4%).