@article{1a5816a44bbe41b0a121053c4d96317a,
title = "Is Dipstick Urinalysis Screening Beneficial in Men with Lower Urinary Tract Symptoms?",
abstract = "Introduction: Dipstick urinalysis is a widely used screening tool in the evaluation of men with lower urinary tract symptoms (LUTS) suggestive of benign prostatic hyperplasia (BPH). As limited data support the use of dipstick urinalysis, we have used data from three recently published studies to assess clinical outcomes in those who had dipstick urinalysis findings for blood, glucose, and/or leukocytes. Methods: We analyzed data from three observational studies involving men interested in using over-the-counter tamsulosin: a self-selection study (SSS) and two actual-use studies of 8-week (AUS8) and 24-week (AUS24) durations. Subgroup analyses focused on pooled data from participants not using α-blockers or other prescription medication for LUTS suggestive of BPH (nonRx users) and who had urine dipstick findings. Data from participants using α-blockers (AUS8) or any prescription BPH medications (SSS and AUS24) are presented as reference. Results: Overall, 2488 nonRx users underwent dipstick urinalysis and 680 (27.3%) had positive findings including traces of blood (332; 13.3%), glucose (259; 10.4%), and/or leukocytes (245; 9.8%). Among users of prescription medicines, 21.6% (37/171) in SSS, 27.4% (23/84) in AUS8, and 31.1% (47/151) in AUS24 had urine dipstick findings. The 200 dipstick-positive nonRx users in SSS underwent per protocol urological assessment: 26 (13.0%) had a newly diagnosed condition causing/contributing to urinary symptoms of which 2.9% were identified as medically important conditions. Among nonRx users with or without a dipstick finding, medically important conditions reported included prostate cancer (1.0% vs. 1.0%, respectively) and urolithiasis (1.0% vs. 0.3%, respectively). The proportion of men with dipstick urinalysis findings was similar between men who regularly visited their physician and those who did not. Conclusion: Dipstick urinalysis did not markedly increase the detection of undiagnosed medically important conditions that cause/contribute to urinary symptoms, suggesting that this test may not be a very effective screening tool for men with LUTS. Funding: Boehringer Ingelheim Pharmaceuticals, Inc.",
keywords = "Benign prostatic hyperplasia, Dipstick, Lower urinary tract symptoms, Urinalysis, Urology",
author = "Lowe, {Franklin C.} and Michel, {Martin C.} and Wruck, {Jan M.} and Verbeek, {Anna E.}",
note = "Funding Information: We thank all participants of the underlying studies. The underlying studies and this analysis were funded by Boehringer Ingelheim Pharmaceuticals, Inc. (BIPI). No Rapid Service Fee was received by the journal for the publication of this article. BIPI funded the open access fee for this article. All authors had full access to all of the data in this study and take complete responsibility for the integrity of the data and accuracy of the data analysis. Writing, editorial support and formatting assistance was provided by Suchita Nath-Sain, Ph.D., and Maribeth Bogush, Ph.D., of Cactus Communications, who were contracted and compensated by BIPI for these services. Boehringer Ingelheim Pharmaceuticals, Inc. was given the opportunity to review the manuscript for medical and scientific accuracy as well as intellectual property considerations. All named authors meet the International Committee of Medical Journal Editors (ICMJE) criteria for authorship for this article, take responsibility for the integrity of the work as a whole, and have given their approval for this version to be published. Franklin Lowe was a consultant for Boehringer Ingelheim at the time the underlying studies were performed and is now affiliated with Weiler Hospital, Albert Einstein College of Medicine, Bronx, NY, USA. Martin C. Michel was an employee of Boehringer Ingelheim at the time the study was conducted and, outside of the submitted work, received personal fees from Apogepha, Astellas, Ferring, Recordati, Dr. Willmar Schwabe and grants from Velicept. Martin C. Michel is now affiliated with Johannes Gutenberg University, Obere Zahlbacher, Mainz, Germany and is a member of the journal{\textquoteright}s Editorial Board. Jan Wruck is an employee of Boehringer Ingelheim. Anna Verbeek was an employee of Boehringer Ingelheim at the time the study was conducted and is currently an employee of Sanofi. The published underlying studies were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki Declaration and its later amendments or comparable ethical standards. Informed consent was obtained from all individual participants included in the studies. Ethics committee approval was not applicable to the post hoc analysis reported in the present manuscript. The underlying studies were approved by independent ethics committees which are detailed in the previous publications. The datasets generated during and/or analyzed during the current study are available from the corresponding author on reasonable request. Publisher Copyright: {\textcopyright} 2019, The Author(s).",
year = "2019",
month = oct,
day = "1",
doi = "10.1007/s12325-019-01042-0",
language = "English (US)",
volume = "36",
pages = "2954--2967",
journal = "Advances in Therapy",
issn = "0741-238X",
publisher = "Health Communications Inc.",
number = "10",
}
