Tolterodine extended release improves overactive bladder symptoms in men with overactive bladder and nocturia.
OBJECTIVE
To evaluate the efficacy and safety of nighttime dosing with tolterodine extended release (TER) in men with overactive bladder (OAB) and nocturia.


METHODS
This was a post hoc analysis of data from two 12-week, double-blind, placebo-controlled trials of nighttime (<4 hours before bedtime) TER (4 mg daily) dosing. Men with a mean micturition frequency of eight or more times in 24 hours, including a mean of 2.5 or more nocturia episodes/night, were included. For each micturition, patients used 7-day diaries to record urinary urgency on a 5-point urgency rating scale (1, none; 2, mild; 3, moderate; 4, severe; 5, urgency urinary incontinence). Micturitions were analyzed post hoc by urgency rating categories: total (1 to 5), non-OAB (1 to 2), OAB (3 to 5), and severe OAB (4 to 5). Adverse events were recorded throughout the study.


RESULTS
A total of 745 men (mean age 64 years) were randomized to placebo (n = 374) or TER (n = 371). Of the 745 men, 73% reported no incontinence episodes in a 7-day diary at baseline. At week 12, the weekly values for nighttime severe OAB micturitions and 24-hour and daytime total, OAB, and severe OAB micturitions were significantly reduced in the TER group versus the placebo group. The TER-treated men also reported a significant reduction in the mean urgency rating versus placebo. Adverse events associated with TER were low and comparable to those in the placebo group, with the exception of dry mouth (11% versus 4%). Withdrawals because of adverse events were infrequent (3% TER, 4% placebo). Five men were withdrawn for symptoms suggestive of urinary retention (3 TER, 2 placebo).


CONCLUSIONS
Nighttime TER dosing reduced urgency-related micturitions and was well tolerated in men with OAB and nocturia.
Kaplan
Steven A
SA
Department of Urology, Weill Cornell Medical College, New York Presbyterian Hospital, New York, New York 10021, USA. kaplans@med.cornell.edu
Roehrborn
Claus G
CG
Dmochowski
Roger
R
Rovner
Eric S
ES
Wang
Joseph T
JT
Guan
Zhonghong
Z
D001559:Benzhydryl Compounds / Q000627:therapeutic use*; D003408:Cresols / Q000627:therapeutic use*; D003692:Delayed-Action Preparations / Q000627:therapeutic use; D006801:Humans; D008297:Male; D008875:Middle Aged; D018727:Muscarinic Antagonists / Q000627:therapeutic use*; D010665:Phenylpropanolamine / Q000627:therapeutic use*; D000068737:Tolterodine Tartrate; D014549:Urinary Incontinence / Q000150:complications / Q000175:diagnosis / Q000188:drug therapy*; D014555:Urination Disorders / Q000150:complications / Q000188:drug therapy
D001559:Benzhydryl Compounds; D003408:Cresols; D003692:Delayed-Action Preparations; D018727:Muscarinic Antagonists; D010665:Phenylpropanolamine; D000068737:Tolterodine Tartrate