PMID- 12139206 OWN - NLM STAT- MEDLINE DCOM- 20030108 LR - 20131121 IS - 0946-1965 (Print) IS - 0946-1965 (Linking) VI - 40 IP - 7 DP - 2002 Jul TI - Trospium chloride in patients with detrusor overactivity: meta-analysis of placebo-controlled, randomized, double-blind, multi-center clinical trials on the efficacy and safety of 20 mg trospium chloride twice daily. PG - 295-303 AB - OBJECTIVES: Primary objective of this meta-analysis was to produce a systematic and quantitative review of two independent clinical trials of 20 mg trospium chloride (TCI) twice daily (b.i.d.) in patients with detrusor overactivity [Alloussi et al. 1998, Cardozo et al. 2000]. PATIENTS AND METHODS: In two placebo-controlled, double-blind, multi-center studies, the effect of TCl on detrusor function was evaluated using urodynamic measurements. All 517 patients were randomized to receive TCl or placebo for 3 weeks. Urodynamic variables were measured at the beginning and at the end of the treatment. Safety was evaluated on the basis of adverse events (AEs), vital signs and laboratory tests. RESULTS: TCl produced significant improvements in 'maximum cystometric bladder capacity' (median treatment effect = 52 ml, 95% confidence interval 32-71 ml, p<0.0001) and 'urinary volume at first unstable contraction' (median treatment effect = 48 ml, 95% confidence interval 28 to 68 ml, p = 0.0001). The patients' assessment of efficacy also showed significantly greater clinical improvement in the TCl group than in the placebo group (p < 0.0001). The patients recorded a 'cure' or a 'marked improvement' more often in the TCl group than in the placebo group (47.9% and 19.7%, respectively). TCl was well tolerated, with similar frequencies of AEs reported in both groups (TCl: 35.7%, placebo group: 38.9%). CONCLUSIONS: Trospium chloride (20 mg twice daily) is an effective and safe medication for the treatment of detrusor overactivity. FAU - Frohlich, G AU - Frohlich G AD - CRMB GmbH, Rheinbach, Germany. gfroehl@tin.it FAU - Bulitta, M AU - Bulitta M FAU - Strosser, W AU - Strosser W LA - eng PT - Journal Article PT - Meta-Analysis PL - Germany TA - Int J Clin Pharmacol Ther JT - International journal of clinical pharmacology and therapeutics JID - 9423309 RN - 0 (Benzilates) RN - 0 (Nortropanes) RN - 0 (Parasympatholytics) RN - 1E6682427E (trospium chloride) SB - IM MH - Benzilates MH - Double-Blind Method MH - Female MH - Humans MH - Male MH - Middle Aged MH - Nortropanes/administration & dosage/adverse effects/*pharmacology MH - Parasympatholytics/administration & dosage/adverse effects/*pharmacology MH - Randomized Controlled Trials as Topic MH - Treatment Outcome MH - Urinary Bladder, Neurogenic/*drug therapy/physiopathology MH - Urodynamics/drug effects EDAT- 2002/07/26 10:00 MHDA- 2003/01/09 04:00 CRDT- 2002/07/26 10:00 PHST- 2002/07/26 10:00 [pubmed] PHST- 2003/01/09 04:00 [medline] PHST- 2002/07/26 10:00 [entrez] PST - ppublish SO - Int J Clin Pharmacol Ther. 2002 Jul;40(7):295-303.