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

Claus G. Roehrborn, Franklin C. Lowe, Marc Gittelman, Jan M. Wruck, Anna E. Verbeek

Research output: Contribution to journalArticle

1 Citation (Scopus)

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.

Original languageEnglish (US)
JournalDrugs and Aging
DOIs
StateAccepted/In press - Jan 1 2019

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tamsulosin
Lower Urinary Tract Symptoms
Pharmaceutical Preparations
Ejaculation
Prostatic Hyperplasia
Dizziness
Semen
Quality of Life
Interviews

ASJC Scopus subject areas

  • Geriatrics and Gerontology
  • Pharmacology (medical)

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Management of Male Lower Urinary Tract Symptoms in a Simulated, Over-the-Counter Setting : An Exploratory Study of Tamsulosin. / Roehrborn, Claus G.; Lowe, Franklin C.; Gittelman, Marc; Wruck, Jan M.; Verbeek, Anna E.

In: Drugs and Aging, 01.01.2019.

Research output: Contribution to journalArticle

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