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The placebo effect in overactive bladder syndrome

Nature Reviews Urology volume 8, pages 495–503 (2011)Cite this article

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Abstract

Overactive bladder syndrome (OAB) is a condition that involves urinary urgency and affected individuals are usually treated with behavioral therapy and antimuscarinic agents as first-line therapies. Existing evidence from clinical trial data suggests that a positive placebo effect occurs in patients receiving treatment for OAB. In our systematic Review of placebo-controlled, randomized trials in OAB, we show statistically significant improvements in three patient-reported outcomes—incontinence episodes per day, micturition episodes per day and mean micturition volume from baseline—after placebo in randomized studies for OAB. The findings could highlight the brain's role in the pathophysiology of OAB or the role of additional bladder training conducted as part of OAB clinical trials. More research is needed to determine the underlying mechanisms of the placebo effect in OAB.

Key Points

  • Patients on placebo in randomized controlled studies for overactive bladder syndrome (OAB) report marked improvements in the outcomes of incontinence episodes per day, micturition episodes per day and mean micturition volume from baseline

  • Urgency, the key symptom of OAB, does not show substantial improvements in the placebo group, although the number of studies reporting this parameter is limited

  • Improvements in urodynamics are not correlated with study size

  • More work is needed to understand the mechanisms that underlie the placebo effect

  • Highlighting the placebo effect in OAB could influence the design of future OAB studies and treatment modalities

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Figure 1: Randomized controlled clinical trials for OAB.
Figure 2: The relationship between study size and change in incontinence episodes per day in OAB randomized controlled trials.
Figure 3: The relationship between study size and change in micturition episodes per day in OAB randomized controlled trials.
Figure 4: The relationship between study size and change in maximum cystometric capacity in OAB randomized controlled trials.

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Authors and Affiliations

  1. Department of Urology, The Royal Hallamshire Hospital, Glossop Road, Sheffield, S10 2JF, UK

    Altaf Mangera & Christopher R. Chapple

  2. Pfizer Inc., 235 E 42nd Street, MS 235/9, New York, 10017, NY, USA

    Zoe S. Kopp

  3. Heron Evidence Development Ltd, Building 210A Butterfield Business Park, Stopsley, LU2 8DL, Luton, UK

    Melanie Plested

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Contributions

Z. S. Kopp and M. Plested researched data for the article. All authors contributed equally to discussion of the content of the article. A. Mangera wrote the article and C. R. Chapple, Z. S. Kopp and M. Plested reviewed and edited the manuscript before submission.

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Correspondence to Altaf Mangera.

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Competing interests

C. R. Chapple has acted as a consultant, received grant/research support, and been a member of a speakers bureau for Astellas Pharma and Pfizer as well as acting as a consultant and receiving grant/research support from Mitsubishi Tanabe Pharma, Novartis and Recordati Pharmaceuticals. Z. S. Kopp is a stockholder/director at Pfizer. M. Plested has received grant/research support from Heron Evidence Development and Pfizer. A. Mangera declares no competing interests.

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Mangera, A., Chapple, C., Kopp, Z. et al. The placebo effect in overactive bladder syndrome. Nat Rev Urol 8, 495–503 (2011). https://doi.org/10.1038/nrurol.2011.99

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