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03.01.2019 | Original Research Article | Ausgabe 2/2019

Drugs & Aging 2/2019

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

Zeitschrift:
Drugs & Aging > Ausgabe 2/2019
Autoren:
Claus G. Roehrborn, Franklin C. Lowe, Marc Gittelman, Jan M. Wruck, Anna E. Verbeek
Wichtige Hinweise

Electronic supplementary material

The online version of this article (https://​doi.​org/​10.​1007/​s40266-018-0621-8) contains supplementary material, which is available to authorized users.

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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Zusatzmaterial
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_MOESM1_ESM.tif
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)
40266_2018_621_MOESM2_ESM.docx
Literatur
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