Open Access

ARTICLE

Characteristics of men with untreated LUTS interested in over-the-counter tamsulosin

Claus G. Roehrborn¹, Franklin C. Lowe², Marc Gittelman³, Jan M. Wruck⁴, Anna E. Verbeek⁵

1 University of Texas Southwestern Medical Center, Dallas, Texas, USA
2 Weiler Hospital, Albert Einstein College of Medicine, Bronx, New York, USA
3 South Florida Medical Research, Uromedix/Division of 21st Century Oncology, Aventura, Florida, USA
4 Boehringer Ingelheim Pharmaceuticals, Inc., Ridgefeld, Connecticut, USA/ 5Sanof, Bridgewater, New Jersey, USA
Address correspondence to Dr. Anna E. Verbeek, Sanofi Consumer Health Care, 55 Corporate Drive, Bridgewater, NJ 08807 USA

Canadian Journal of Urology 2019, 26(4), 9821-9828.

Abstract

Introduction: Treatment for lower urinary tract symptoms (LUTS) is often delayed, as it is considered a natural progression of aging. We described baseline demographic and clinical characteristics of men currently not using prescription medications for benign prostatic hyperplasia (BPH) but interested in self-directed use of over-the-counter (OTC) tamsulosin and who had participated in OTC tamsulosin–simulated studies.
Materials and methods: Pooled baseline data from four OTC tamsulosin–simulated studies were analyzed for men who were currently not using BPH prescription medication and who believed that OTC tamsulosin was appropriate for use or were interested in purchasing it. Data from the OTC-simulated studies for men using BPH prescription medication and from the BPH registry, which included men diagnosed with BPH, were used for comparison.
Results: Overall, 3285 non-prescription-using men (mean age ± standard deviation [SD], 60.6 ± 11.6 years) were included. Average American Urological Association Symptom Index (AUA-SI) total score was 17.6; 25.5% reported urinary symptoms for > 5 years. Overall, 46.7% of these men had > 1 visit/year with their physicians. Baseline characteristics of prescription users from the OTC-simulated studies (n = 364; mean age ± SD, 68.3 ± 9.1 years; mean AUA-SI score, 18.5) and of men from the BPH registry (n = 5042; 64.8 ± 10 years; 11.6) were similar to those of non-prescription users.
Conclusions: Non-prescription users had long term moderate-to-severe male LUTS, yet remained untreated; self-management may be a viable alternative strategy for this population. Disease characteristics of men not using BPH prescription medication and interested in using OTC tamsulosin were similar to those using BPH medication or diagnosed with BPH.

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