Trial reportDrugs & aging2019
Management of Male Lower Urinary Tract Symptoms in a Simulated, Over-the-Counter Setting: An Exploratory Study of Tamsulosin.
Trial report in Drugs & aging, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01726270 (A 8-week, Open-label, Uncontrolled, Exploratory Actual Use Study of Tamsulosin 0.4mg in Men With Prostate Urinary Symptoms in a Simulated Over-the-Counter Environment), which is not on this map. Cited by 3 papers.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
A 8-week, Open-label, Uncontrolled, Exploratory Actual Use Study of Tamsulosin 0.4mg in Men With Prostate Urinary Symptoms in a Simulated Over-the-Counter Environment
Who cites it
3 citing papers in PubMed.
- Alpha-Adrenoceptor Blockade as a Novel Pathway Toward Non-Hormonal Male Contraception: A Mechanistic and Clinical Evidence Review.Journal of clinical medicine · 2026Review
- A Detailed Analysis of the Past 20 Years of US FDA-Approved Prescription to Over-the-Counter Switches.Therapeutic innovation & regulatory science · 2023Article
- Is Dipstick Urinalysis Screening Beneficial in Men with Lower Urinary Tract Symptoms?Advances in therapy · 2019Observational
Corrections and comments
- Commented on by
Authors and funding
5 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundLower urinary tract symptoms (LUTS) attributed to benign prostatic hyperplasia (BPH) are common in men, considerably affecting quality of life.
aimsThe 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.
methodsMen (≥ 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).
resultsOf 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.
conclusionsOf 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 registrationClinicalTrials.gov NCT01726270.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.