Tolterodine extended release improves overactive bladder symptoms in men with overactive bladder and nocturia

Steven A. Kaplan, Claus Roehrborn, Roger Dmochowski, Eric S. Rovner, Joseph T. Wang, Zhonghong Guan

Research output: Contribution to journalArticle

62 Citations (Scopus)

Abstract

Objectives: 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 Five men were withdrawn for symptoms suggestive of urinary retention (3 TER, 2 placebo).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.

Original languageEnglish (US)
Pages (from-to)328-332
Number of pages5
JournalUrology
Volume68
Issue number2
DOIs
StatePublished - Aug 2006

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Nocturia
Overactive Urinary Bladder
Urination
Placebos
Tolterodine Tartrate
Urinary Retention
Urinary Incontinence
Mouth
Urinary Bladder
Safety

ASJC Scopus subject areas

  • Urology

Cite this

Tolterodine extended release improves overactive bladder symptoms in men with overactive bladder and nocturia. / Kaplan, Steven A.; Roehrborn, Claus; Dmochowski, Roger; Rovner, Eric S.; Wang, Joseph T.; Guan, Zhonghong.

In: Urology, Vol. 68, No. 2, 08.2006, p. 328-332.

Research output: Contribution to journalArticle

Kaplan, Steven A. ; Roehrborn, Claus ; Dmochowski, Roger ; Rovner, Eric S. ; Wang, Joseph T. ; Guan, Zhonghong. / Tolterodine extended release improves overactive bladder symptoms in men with overactive bladder and nocturia. In: Urology. 2006 ; Vol. 68, No. 2. pp. 328-332.
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abstract = "Objectives: 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.",
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AU - Kaplan, Steven A.

AU - Roehrborn, Claus

AU - Dmochowski, Roger

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AU - Wang, Joseph T.

AU - Guan, Zhonghong

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AB - Objectives: 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.

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