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European Urology
Volume 55, issue 5, pages 1003-1250, May 2009Letters to the Editor published online
Reply to David R. Staskin and Michael G. Oefelein's Letter to the Editor re: Giacomo Novara, Antonio Galfano, Silvia Secco, et al. A Systematic Review and Meta-Analysis of Randomized Controlled Trials with Antimuscarinic Drugs for Overactive bladder. Eur Urol 2008;54:740–64
Giacomo Novara a 
, Walter Artibani b.
Accepted 16 October 2008, Published online 24 October 2008, pages e86 - e87
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Refers to article:
A Systematic Review and Meta-Analysis of Randomized Controlled Trials with Antimuscarinic Drugs for Overactive Bladder
Accepted 25 June 2008
October 2008 (Vol. 54, Issue 4, pages 740 - 764)
Refers to article:
Re: Giacomo Novara, Antonio Galfano, Silvia Secco, et al. A Systematic Review and Meta-Analysis of Randomized Controlled Trials with Antimuscarinic Drugs for Overactive Bladder. Eur Urol 2008;54:74064
Accepted 16 October 2008
May 2009 (Vol. 55, Issue 5, pages e84 - e85)
Article Outline
We read with interest the letter of Drs. Oefelein and Staskin [1] concerning our meta-analysis of randomized controlled trials (RCTs) on antimuscarinic drugs for overactive bladder syndrome (OAB) [2]. We thank the authors for their interest in our paper. We do believe that trospium is a valuable option for the treatment of patients with OAB.
With regard to the criticisms of our review, the systematic search of the literature that was the basis of the meta-analysis was performed in August 2007, as stated in the text. Trospium was one of the keywords, and two active-controlled trials evaluating trospium in comparison with oxybutynin immediate release (IR) 5 mg and tolterodine IR 2 mg were included in the meta-analysis [3], and [4]. Clearly, all of the RCTs indexed in Medline, Embase, or Web of Science thereafter cannot be present in our review.
As declared in the “Methods” section of our meta-analysis, all of the studies “comparing different drugs, formulations, doses, and routes of administration were considered,” including data of efficacy and complications of anticholinergic drugs [2]. In other words, only the active-controlled trials were evaluated, which explains why the trial from Zinner et al [5] on trospium was not cited in our review. The trial from Nitti et al, listed as reference 34 in the meta-analysis, randomized 836 patients to fesoterodine 4 mg, fesoterodine 8 mg, or placebo [6]. The study was included in the subsection “Comparisons of different doses and formulations of the same drug” to evaluate the efficacy of two different doses of fesoterodine, and no data on the placebo arm was reported.
Finally, the Review Manager software that was used for the meta-analysis allowed inclusion of continuous variables only if expressed as mean and standard deviation. Consequently, all of the RCTs that reported continuous data as median and ranges were not suitable for the meta-analysis, although they were showed in the tables summarizing the systematic review. This issue, however, was not relevant for the studies quoted by Drs. Oefelein and Staskin, which were not included in the meta-analyses because they lacked an active control.
We did our best to provide as unbiased a text as possible, and we were helped in this hard task by the precious collaboration of seven reviewers of European Urology. I can understand the reasons for the complains of Drs. Oefelein and Staskin, which were very similar to those moved by the same authors toward a recent meta-analysis by Chapple et al [7], and [8]. We do believe, however, that no update of the meta-analysis is currently needed.
Conflicts of interest: Dr. Novara has been a consultant, investigator, or speaker for Bioxell, GlaxoSmithKleine, Pfizer Inc., and Pierre Fabre. Prof. Artibani has been a consultant, investigator, or speaker for Astellas, Bayer, Bioxell, Novartis, Pfizer Inc., Pierre Fabre, and UCB.
References
- [1] Staskin DR, Oefelein MG. Re: Giacomo Novara, Antonio Galfano, Silvia Secco, et al. A systematic review and meta-analysis of randomized controlled trials with antimuscarinic drugs for overactive bladder. Eur Urol 2008;54:740–64. Eur Urol 2009;55:e84–5.
- [2] G. Novara, A. Galfano, S. Secco, et al.. A systematic review and meta-analysis of randomized controlled trials with antimuscarinic drugs for overactive bladder. Eur Urol 54 (2008) (740 - 764) Abstract, Full-text, PDF, Crossref.
- [3] M. Halaska, G. Ralph, A. Wiedemann, et al.. Controlled, double-blind, multicentre clinical trial to investigate long-term tolerability and efficacy of trospium chloride in patients with detrusor instability. World J Urol 20 (2003) (392 - 399)
- [4] K.P. Junemann, S. Al-Shukri. Efficacy and tolerability of trospium chloride and tolterodine in 234 patients with urgesyndrome: a double blind, placebo-controlled, multicentre clinical trial [abstract]. Neurourol Urodynam (2000) (488 - 490)
- [5] N. Zinner, M. Gittelman, R. Harris, J. Susset, A. Kanellos, S. Auerbach. Trospium chloride improves overactive bladder symptoms: a multicenter phase III trial. J Urol 171 (2004) (2311 - 2315) Crossref.
- [6] V.W. Nitti, R. Dmochowski, P.K. Sand, et al.. Efficacy, safety, and tolerability of fesoterodine for overactive bladder syndrome. J Urol 178 (2007) (2488 - 2494) Crossref.
- [7] C.R. Chapple, V. Khullar, Z. Gabriel, et al.. The effects of antimuscarinic treatments in overactive bladder: an update of a systematic review and meta-analysis. Eur Urol 54 (2008) (543 - 562) Abstract, Full-text, PDF, Crossref.
- [8] Staskin DR, Oefelein MG. Re: Christopher R. Chapple, Vik Khullar, Zahava Gabriel, et al. The effects of antimuscarinic treatments in overactive bladder: an update of a systematic review and meta-analysis. Eur Urol 2008;54:543–62. Eur Urol 2009;55:e49–50.
Footnotes
a I.R.C.C.S. Istituto Oncologico Veneto (I.O.V.), Padua, Italy
b Department of Oncological and Surgical Sciences, Urology Clinic, University of Padua, Padua, Italy
Corresponding author. I.R.C.C.S. Istituto Oncologico Veneto, Department of Oncological and Surgical Sciences, Urology Clinic, University of Padua, Via Giustiniani 2, 35100 Padua, Italy. Tel. +39 049 8212720; Fax: +39 049 8218757.
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