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Management of Male Lower Urinary Tract Symptoms in a Simulated, Over-the-Counter Setting: An Exploratory Study of Tamsulosin

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Abstract

Background

Lower urinary tract symptoms (LUTS) attributed to benign prostatic hyperplasia (BPH) are common in men, considerably affecting quality of life.

Aims

The self-directed use of over-the-counter (OTC) tamsulosin (0.4 mg) and potential safety risks were evaluated in an open-label, uncontrolled, exploratory, 8-week OTC-simulated study.

Methods

Men (≥ 18 years) were recruited via mass advertising about bothersome LUTS. In a working retail environment, respondents reviewed the product and decided whether it was appropriate for them to use (self-selection phase). After purchasing the product, participants’ ability to use it as directed by the proposed drug facts label (DFL) was assessed (home-use phase).

Results

Of 1446 eligible men, 679 completed the self-selection phase, and 73.9% (502/679) self-selected to use tamsulosin correctly according to the DFL. Of 369 participants who purchased tamsulosin and entered the home-use phase, 321 took one or more doses of tamsulosin and participated in at least one telephone interview. In total, 85.4% (274/321) of participants adhered to the ‘Stop Use’ and ‘Directions’ instructions in the DFL. Overall, 139 (39.6%) participants experienced one or more adverse events (AEs); 65 (18.5%) were deemed drug-related, including dizziness (11 [3.1%]), ejaculation disorder (6 [1.7%]), and semen volume decrease (6 [1.7%]). No unexpected AEs were reported.

Conclusions

Of the men interested in self-managing their LUTS, a majority had moderate-to-severe LUTS of long duration. Most men were able to appropriately self-select and use tamsulosin in concordance with DFL instructions and directions. No unexpected AEs were reported during self-directed use. With further label refinement, an over-the-counter tamsulosin option might be feasible.

Trial registration

ClinicalTrials.gov NCT01726270.

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Acknowledgements

The study was sponsored by Boehringer Ingelheim Pharmaceuticals, Inc. (BIPI), Ridgefield, CT, USA. The authors meet criteria for authorship as recommended by the International Committee of Medical Journal Editors. The authors received no direct compensation related to the development of the manuscript. Writing, editorial support, and formatting assistance was provided by Michelle Rebello, Ph.D., and Maribeth Bogush, MCI, Ph.D., of Cactus Communications, which was contracted and compensated by BIPI for these services. BIPI was given the opportunity to review the manuscript for medical and scientific accuracy as well as intellectual property considerations.

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Author notes

  1. Anna E. Verbeek

    Present address: Sanofi, 55 Corporate Drive, Bridgewater, NJ, 08807, USA

Authors and Affiliations

  1. University of Texas Southwestern Medical Center, Dallas, TX, USA

    Claus G. Roehrborn

  2. Weiler Hospital, Albert Einstein College of Medicine, Bronx, NY, USA

    Franklin C. Lowe

  3. South Florida Medical Research, Uromedix/Division of 21st Century Oncology, Aventura, FL, USA

    Marc Gittelman

  4. Boehringer Ingelheim Pharmaceuticals, Inc., Ridgefield, CT, USA

    Jan M. Wruck & Anna E. Verbeek

Authors
  1. Claus G. Roehrborn
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  2. Franklin C. Lowe
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  3. Marc Gittelman
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  4. Jan M. Wruck
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  5. Anna E. Verbeek
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Corresponding author

Correspondence to Anna E. Verbeek.

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Funding

The study was sponsored by Boehringer Ingelheim Pharmaceuticals, Inc. (BIPI), Ridgefield, CT, USA.

Conflict of interest

CGR, FCL, and MG are consultants/advisors for Boehringer Ingelheim; JMW is an employee of Boehringer Ingelheim. AEV was an employee of Boehringer Ingelheim at the time of the study.

Electronic supplementary material

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40266_2018_621_MOESM1_ESM.tif

Supplementary Fig. 1 Study populations. EVAL-AUS evaluable analysis set for actual-use decision, EVAL-SS evaluable analysis set for self-selection, FAS-AUS full analysis set for actual use decision, TS treated set (TIFF 2651 kb)

40266_2018_621_MOESM2_ESM.docx

Supplementary Table 1 Baseline characteristics of α-blocker and non-α-blocker users (self-selection phase). Supplementary Table 2 Correct and incorrect self-selection decisions (self-selection phase). Supplementary Table 3 Quality of life (home-use phase) (DOCX 31 kb)

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Roehrborn, C.G., Lowe, F.C., Gittelman, M. et al. Management of Male Lower Urinary Tract Symptoms in a Simulated, Over-the-Counter Setting: An Exploratory Study of Tamsulosin. Drugs Aging 36, 179–188 (2019). https://doi.org/10.1007/s40266-018-0621-8

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  • DOI: https://doi.org/10.1007/s40266-018-0621-8

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