TY - JOUR
T1 - Management of Male Lower Urinary Tract Symptoms in a Simulated, Over-the-Counter Setting
T2 - An Exploratory Study of Tamsulosin
AU - Roehrborn, Claus G.
AU - Lowe, Franklin C.
AU - Gittelman, Marc
AU - Wruck, Jan M.
AU - Verbeek, Anna E.
N1 - Publisher Copyright:
© 2019, Springer Nature Switzerland AG.
PY - 2019/2/11
Y1 - 2019/2/11
N2 - 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.
AB - 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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U2 - 10.1007/s40266-018-0621-8
DO - 10.1007/s40266-018-0621-8
M3 - Article
C2 - 30607798
AN - SCOPUS:85059580003
SN - 1170-229X
VL - 36
SP - 179
EP - 188
JO - Drugs and Aging
JF - Drugs and Aging
IS - 2
ER -