Efficacy and tolerability of tolterodine extended-release in men with overactive bladder and urgency urinary incontinence

Claus Roehrborn, Paul Abrams, Eric S. Rovner, Steven A. Kaplan, Sender Herschorn, Zhonghong Guan

Research output: Contribution to journalArticle

64 Citations (Scopus)

Abstract

OBJECTIVE: To evaluate the efficacy and tolerability of tolterodine extended-release (ER) on objective and subjective endpoints in men with overactive bladder (OAB) and urgency urinary incontinence (UI). PATIENTS AND METHODS: This was a post hoc analysis of data collected from men with OAB enrolled in a 12-week, double-blind, placebo-controlled trial of tolterodine ER (4 mg once daily; tolterodine ER registration trial) and included men with urinary frequency (≥8 micturitions/24 h) and urgency UI (≥5 episodes/week). UI episodes were assessed using 7-day bladder diaries. Patient perception of treatment benefit was evaluated after 12 weeks. Adverse events (AEs) were recorded throughout the study. RESULTS: In all, 163 men with OAB (placebo, 86; tolterodine ER, 77; mean age 65 years) were evaluated. Baseline demographics and clinical characteristics were similar for the two treatment groups. Compared with placebo, tolterodine ER significantly reduced weekly UI episodes (median % change, -71% vs -40%, P < 0.05; mean numeric change, -11.9 vs -5.9, P = 0.02). Men receiving tolterodine ER had fewer micturitions/24 h, but this was not a significant difference from placebo (median % change, -12% vs -4%, P = 0.22). Significantly more men treated with tolterodine-ER (63%) than placebo-treated men (46%) reported a benefit of treatment after 12 weeks (P = 0.04). The most commonly reported AEs associated with tolterodine-ER vs placebo were dry mouth (16% vs 7%), constipation (4% vs 9%), dyspepsia (4% vs 1%), dizziness (5% vs 1%), and somnolence (3% vs 1%). One of the men receiving tolterodine ER had symptoms suggestive of urinary retention that led to his withdrawal from the study. None of the men had acute urinary retention requiring catheterization. CONCLUSION: In men with OAB and urgency UI, tolterodine ER was well tolerated and significantly reduced episodes of urgency UI, and improved patient perception of treatment benefit.

Original languageEnglish (US)
Pages (from-to)1003-1006
Number of pages4
JournalBJU International
Volume97
Issue number5
DOIs
StatePublished - May 2006

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Overactive Urinary Bladder
Urinary Incontinence
Placebos
Urinary Retention
Urination
Tolterodine Tartrate
Dyspepsia
Dizziness
Constipation
Therapeutics
Catheterization
Mouth
Urinary Bladder
Demography

Keywords

  • Men
  • Overactive bladder
  • Tolterodine
  • Urinary incontinence

ASJC Scopus subject areas

  • Urology

Cite this

Efficacy and tolerability of tolterodine extended-release in men with overactive bladder and urgency urinary incontinence. / Roehrborn, Claus; Abrams, Paul; Rovner, Eric S.; Kaplan, Steven A.; Herschorn, Sender; Guan, Zhonghong.

In: BJU International, Vol. 97, No. 5, 05.2006, p. 1003-1006.

Research output: Contribution to journalArticle

Roehrborn, Claus ; Abrams, Paul ; Rovner, Eric S. ; Kaplan, Steven A. ; Herschorn, Sender ; Guan, Zhonghong. / Efficacy and tolerability of tolterodine extended-release in men with overactive bladder and urgency urinary incontinence. In: BJU International. 2006 ; Vol. 97, No. 5. pp. 1003-1006.
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AU - Kaplan, Steven A.

AU - Herschorn, Sender

AU - Guan, Zhonghong

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N2 - OBJECTIVE: To evaluate the efficacy and tolerability of tolterodine extended-release (ER) on objective and subjective endpoints in men with overactive bladder (OAB) and urgency urinary incontinence (UI). PATIENTS AND METHODS: This was a post hoc analysis of data collected from men with OAB enrolled in a 12-week, double-blind, placebo-controlled trial of tolterodine ER (4 mg once daily; tolterodine ER registration trial) and included men with urinary frequency (≥8 micturitions/24 h) and urgency UI (≥5 episodes/week). UI episodes were assessed using 7-day bladder diaries. Patient perception of treatment benefit was evaluated after 12 weeks. Adverse events (AEs) were recorded throughout the study. RESULTS: In all, 163 men with OAB (placebo, 86; tolterodine ER, 77; mean age 65 years) were evaluated. Baseline demographics and clinical characteristics were similar for the two treatment groups. Compared with placebo, tolterodine ER significantly reduced weekly UI episodes (median % change, -71% vs -40%, P < 0.05; mean numeric change, -11.9 vs -5.9, P = 0.02). Men receiving tolterodine ER had fewer micturitions/24 h, but this was not a significant difference from placebo (median % change, -12% vs -4%, P = 0.22). Significantly more men treated with tolterodine-ER (63%) than placebo-treated men (46%) reported a benefit of treatment after 12 weeks (P = 0.04). The most commonly reported AEs associated with tolterodine-ER vs placebo were dry mouth (16% vs 7%), constipation (4% vs 9%), dyspepsia (4% vs 1%), dizziness (5% vs 1%), and somnolence (3% vs 1%). One of the men receiving tolterodine ER had symptoms suggestive of urinary retention that led to his withdrawal from the study. None of the men had acute urinary retention requiring catheterization. CONCLUSION: In men with OAB and urgency UI, tolterodine ER was well tolerated and significantly reduced episodes of urgency UI, and improved patient perception of treatment benefit.

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