Once daily trospium chloride is effective and well tolerated for the treatment of overactive bladder: results from a multicenter phase III trial.
OBJECTIVE
An extended release formulation of trospium chloride was recently developed for the once daily treatment of overactive bladder. We investigated the safety, efficacy and tolerability of 60 mg trospium chloride once daily.


METHODS
Subjects with overactive bladder were randomized 1:1 to receive 60 mg trospium chloride once daily or placebo in this 12-week multicenter, parallel, double-blind, placebo controlled trial. Primary end points were calculated changes in diary recorded daily urinary frequency and daily urgency urinary incontinence episodes. Secondary end points were urgency severity, volume voided per void and the number of urgency voids per day. Safety was assessed by clinical examination, adverse event monitoring, clinical laboratory values and resting electrocardiograms.


RESULTS
Overall 601 subjects were prescribed trospium once daily (298) or placebo (303). Trospium once daily treatment resulted in significant improvements over placebo in all primary and key secondary efficacy outcomes at weeks 1 through 12. The most common adverse events were dry mouth (trospium 8.7% vs placebo 3%) and constipation (trospium 9.4% vs placebo 1.3%). Central nervous system adverse events were rare (headache with trospium 1.0% vs placebo 2.6%). No clinically meaningful changes in laboratory, physical examination or electrocardiogram parameters were noted.


CONCLUSIONS
Trospium 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.
Staskin
David
D
Department of Urology, New York Presbyterian Hospital, Weill-Cornell Medical College, New York, New York 10021, USA. das2021@med.cornell.edu
Sand
Peter
P
Zinner
Norman
N
Dmochowski
Roger
R
D001561:Benzilates; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D009662:Nortropanes / Q000008:administration & dosage* / Q000009:adverse effects; D010276:Parasympatholytics / Q000008:administration & dosage* / Q000009:adverse effects; D053201:Urinary Bladder, Overactive / Q000188:drug therapy* / Q000503:physiopathology; D014554:Urination / Q000187:drug effects
D001561:Benzilates; D009662:Nortropanes; D010276:Parasympatholytics; C003330:trospium chloride