Document Detail

Tolterodine reduces the number of urge incontinence episodes in patients with an overactive bladder.
MedLine Citation:
PMID:  11516807     Owner:  NLM     Status:  MEDLINE    
OBJECTIVE: To evaluate the efficacy, safety and tolerability of tolterodine compared to placebo in patients with an overactive bladder. STUDY DESIGN: A double-blind, multi-centre phase III study in France and Belgium 251 patients with overactive bladder symptoms, and urodynamically verified detrusor overactivity, were randomised to receive 4-week treatment with either placebo or tolterodine 1 or 2mg twice daily (bd). Efficacy was evaluated from patient micturition diaries. Safety and tolerability endpoints were also evaluated. RESULTS: After 4-week treatment, the number of incontinence episodes/24h decreased significantly relative to placebo in the tolterodine 1 and 2 mgbd groups (P=0.045 and P=0.0089, respectively). Both dosages of tolterodine increased volume voided per micturition compared with placebo (P=0.055 and P=0.056, respectively), although significant decreases in micturition frequency were not apparent. Tolterodine was safe and well tolerated, few patients were withdrawn due to adverse events. Dry mouth, mainly of mild-to-moderate intensity, was the most common adverse event. No clinically relevant changes in blood pressure or laboratory safety variables were reported. CONCLUSION: Tolterodine is effective, safe and well tolerated for the treatment of symptoms of an overactive bladder, particularly urge incontinence.
B Jacquetin; J Wyndaele
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Publication Detail:
Type:  Clinical Trial; Clinical Trial, Phase III; Journal Article; Multicenter Study; Randomized Controlled Trial; Research Support, Non-U.S. Gov't    
Journal Detail:
Title:  European journal of obstetrics, gynecology, and reproductive biology     Volume:  98     ISSN:  0301-2115     ISO Abbreviation:  Eur. J. Obstet. Gynecol. Reprod. Biol.     Publication Date:  2001 Sep 
Date Detail:
Created Date:  2001-08-22     Completed Date:  2001-12-04     Revised Date:  2006-11-15    
Medline Journal Info:
Nlm Unique ID:  0375672     Medline TA:  Eur J Obstet Gynecol Reprod Biol     Country:  Ireland    
Other Details:
Languages:  eng     Pagination:  97-102     Citation Subset:  IM    
Urogynaecology Unit, Hôtel Dieu Maternité, CHU, BP 69-63003 Cedex 1, Clermont-Ferrand, France.
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MeSH Terms
Aged, 80 and over
Benzhydryl Compounds / adverse effects,  therapeutic use*
Cresols / adverse effects,  therapeutic use*
Double-Blind Method
Middle Aged
Muscarinic Antagonists / adverse effects,  therapeutic use*
Urinary Bladder Diseases / complications*,  drug therapy
Urinary Incontinence / drug therapy*,  etiology
Reg. No./Substance:
0/Benzhydryl Compounds; 0/Cresols; 0/Muscarinic Antagonists; 0/Placebos; 124937-51-5/tolterodine; 14838-15-4/Phenylpropanolamine

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