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Trospium chloride extended release is effective and well tolerated in women with overactive bladder syndrome

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Abstract

Introduction and hypothesis

To confirm the efficacy and tolerability of extended release (ER) trospium chloride in women with overactive bladder syndrome (OAB), data from two identical phase III studies were analyzed.

Methods

Adults (aged ≥ 18 years) who had OAB with urinary urgency, frequency, and urge urinary incontinence (UUI) were randomized to trospium ER 60 mg or placebo once daily for 12 weeks. The analysis included 989 women (trospium ER, n = 484; placebo, n = 505). Endpoints examined included changes from baseline in number of toilet voids and UUI episodes/day at week 12. Continuous data were analyzed using rank analysis of variance.

Results

At week 12, significantly greater mean reductions in numbers of toilet voids and UUI episodes/day occurred with trospium ER versus placebo (P < 0.0001). Adverse events considered at least possibly related to treatment with trospium ER included dry mouth (11.4%) and constipation (8.9%).

Conclusions

Trospium ER was effective and well tolerated in women with OAB.

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Acknowledgements

Editorial support for the development of this manuscript was provided by Catherine Rees and Sushma Soni. This support was funded by Allergan, Inc.

Funding

This work was supported by Allergan, Inc. and Endo Pharmaceuticals (formerly Indevus Pharmaceuticals Inc.).

Conflicts of interest

Peter K. Sand, MD, serves as an advisor and speaker for Allergan, Inc., Astellas Pharma US, Inc., Pfizer, Ortho-McNeil, Colplast, and Watson Pharmaceuticals. Dr. Sand has received grants from Allergan, Inc., Astellas Pharma US, Inc., Boston Scientific, Pfizer, Ortho-McNeil, Watson Pharmaceuticals, and Antares Pharma.

Roger R. Dmochowski, MD, has financial relationships with Allergan, Inc., Pfizer, Watson Pharmaceuticals, Novartis, and Astellas Pharma US, Inc.

David R. Staskin, MD, serves as a consultant and lecturer for Allergan, Inc., Pfizer, Watson Pharmaceuticals, and Astellas Pharma US, Inc.

Norman R. Zinner, MD, serves as a consultant, speaker, and/or for a clinical trial for Allergan, Inc., Actelion, Watson Pharmaceuticals, Pfizer, Novartis, Ferring Pharmaceuticals, and GlaxoSmithKline.

Rodney A. Appell, MD (deceased), was on the advisory board for Pfizer, Boston Scientific, and Astellas Pharma US, Inc. Dr. Appell held stock in American Medical Systems. Dr. Appell served as an investigator for Allergan, Inc., Astellas Pharma US, Inc., Watson Pharmaceuticals, American Medical Systems, Boston Scientific, Solace Technology, Bulkamid, and Novasys Medical.

Author information

Authors and Affiliations

  1. Division of Urogynecology and Reconstructive Surgery, NorthShore University HealthSystem, Pritzker School of Medicine, University of Chicago, Evanston, IL, USA

    Peter K. Sand

  2. Vanderbilt University School of Medicine, Nashville, TN, USA

    Roger R. Dmochowski

  3. Western Clinical Research, Torrance, CA, USA

    Norman R. Zinner

  4. Division of Urology, Caritas St. Elizabeth’s Medical Center, Tufts University School of Medicine, Boston, MA, USA

    David R. Staskin

  5. Baylor College of Medicine, Houston, TX, USA

    Rodney A. Appell

  6. Evanston Continence Center, 1000 Central Street, Suite 730, Evanston, IL, 60201, USA

    Peter K. Sand

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  1. Peter K. Sand
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  2. Roger R. Dmochowski
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  3. Norman R. Zinner
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  4. David R. Staskin
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  5. Rodney A. Appell
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Corresponding author

Correspondence to Peter K. Sand.

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Rodney A. Appell: deceased

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Sand, P.K., Dmochowski, R.R., Zinner, N.R. et al. Trospium chloride extended release is effective and well tolerated in women with overactive bladder syndrome. Int Urogynecol J 20, 1431–1438 (2009). https://doi.org/10.1007/s00192-009-0969-8

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  • DOI: https://doi.org/10.1007/s00192-009-0969-8

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