Over-the-Counter Tamsulosin for Men with Urinary Symptoms: A Simulated Self-Selection Study

We determined whether consumers who self-select to use tamsulosin for urinary symptoms can make appropriate decisions without health care provider guidance in a simulated over-the-counter setting.

In a simulated retail setting eligible participants (18 years old or older) reviewed a mock-up of Flomax® over-the-counter packaging and determined whether it was right for them to use tamsulosin capsules (0.4 mg). Per an a priori mitigation procedure 3 urologists reviewed self-reported data, dipstick urinalysis results and AUA-SI (American Urological Association symptom index) scores of men who self-selected tamsulosin as appropriate to use despite information on the drug facts label instructing otherwise. Seemingly incorrect decisions were revised to "appropriate" if deemed well-informed and medically acceptable by 2 or 3 urologists.

Overall 619 men and 38 women (mean age 60.9 and 51.6 years, respectively) were enrolled. Of the 470 (75.9%) men who self-selected to use tamsulosin 82 (17.4%) had low health literacy per the REALM (Rapid Estimate of Adult Literacy in Medicine) test and 365 (77.7%) reported seeing a physician at least once a year. Mean AUA-SI total score was 16.5 and 380 (80.9%) men reported urinary symptoms for 1 year or more. The proportions of men who made appropriate self-selection decisions in unmitigated and mitigated analyses were 92.8% (95% CI 90.0-94.9) and 97.9% (95% CI 96.1-99.0), respectively, and findings were similar regardless of health literacy level. Overall 36 of the 38 women (94.7%) made an appropriate decision not to use tamsulosin.

These findings support the potential use of over-the-counter tamsulosin for male urinary symptoms.