Robert Pickard led the review process.
Article first published online: 28 OCT 2011
Copyright © 2011 Wiley Periodicals, Inc.
Neurourology and Urodynamics
Volume 31, Issue 1, pages 22–29, January 2012
How to Cite
Shamliyan, T. A., Kane, R. L., Wyman, J. and Sainfort, F. (2012), Results availability from clinical research of female urinary incontinence. Neurourol. Urodyn., 31: 22–29. doi: 10.1002/nau.21220
Conflict of interest: none.
The authors of this report are responsible for its content. Statements in the report should not be construed as endorsement by the Agency for Healthcare Research and Quality or the U.S. Department of Health and Human Services.
Role of the funding source: The Agency for Healthcare Research and Quality provided funding. The funding source suggested the initial research questions and provided copyright release for this article, but had no role in the design, conduct, analysis, or reporting of the data, or in the decision to submit this article for publication.
- Issue published online: 23 JAN 2012
- Article first published online: 28 OCT 2011
- Manuscript Accepted: 24 AUG 2011
- Manuscript Received: 17 MAY 2011
- Agency for Healthcare Research and Quality, U.S. Department of Health and Human Services. Grant Number: 290-2007-10064 I
- clinical trials as topic;
- government regulation;
- National Library of Medicine (U.S.);
- outcome assessment (health care);
- public policy;
- quality control;
- urinary incontinence
To ascertain possible publication bias by examining the completeness and publication of studies on nonsurgical treatments for female urinary incontinence (UI).
We analyzed information about studies from several trial registries through May 2010. We searched Medline using study registration identifiers to determine publication status, and compared percentages of completed and published studies by study and subject characteristics.
Among the 166 closed studies, we found 120 completed (73%), 12 terminated (7%), 3 withdrawn (2%), and 4 (2%) that provided no reasons for noncompletion. Only 17% of closed registered studies (28/166 studies) were published in peer-reviewed journals; publication that did occur was an average of 2.2 years after study completion. The proportion of studies published did not increase over time. Studies sponsored by industry were published less often than those funded by NIH (OR = 0.04; 95%CI: 0.004–0.38). Drug studies were published less often than studies of other interventions (OR = 0.22; 95%CI: 0.05–0.96). Of the 166 closed studies, 7 (4%) posted results on the ClinicalTrials.gov website. Of Phases III and IV trials, 7% and 3% posted results, respectively.
The absence of results from a substantial proportion of conducted studies suggests that treatment decisions for women with UI are based on selected rather than comprehensive evidence of benefits and harms. Regulatory policy for clinical research should guarantee availability of the outcomes for the public, clinicians, and policymakers. Neurourol. Urodynam. 31:22–29, 2012. © 2011 Wiley Periodicals, Inc.