Feasibility of an Alternative Option for the Management of Male Lower Urinary Tract Symptoms

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

doi:10.1016/j.juro.2015.08.098

Cited by 8 publications

(4 citation statements)

References 15 publications

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“…Such studies are used by regulators to determine whether consumers will be able to safely and effectively utilize a drug in an OTC environment (i.e., using information on the proposed labeling instead of a healthcare professional) [11]. Some consumer research studies of the DFLs for specific drugs are published in peer-reviewed journal articles [12,13,14,15,16,17], while others can be found in the meeting materials posted by the FDA’s Nonprescription Drug Advisory Committee [18].…”

Section: Label Comprehension Self-selection and Actual Use Studiesmentioning

confidence: 99%

The Effectiveness of Nonprescription Drug Labels in the United States: Insights from Recent Research and Opportunities for the Future

Catlin

Brass

2018

Pharmacy

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Despite providing a consistent and comprehensible format for over-the-counter (OTC) drug communication, research suggests important limitations in the communication effectiveness of the Drug Facts Label required on OTC drugs in the United States. This literature is reviewed and some of these critical limitations of the Drug Facts Label (DFL) highlighted. These include difficulty communicating complex information that requires integration of multiple pieces of label information and limited adaptability to serve the unique needs of individual populations (e.g., low literacy or older consumers). Potential ways to improve the DFL’s communication effectiveness are identified along with complementary opportunities to improve OTC drug communication by leveraging the role of pharmacists and use of adjunctive technologies.

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Section: Label Comprehension Self-selection and Actual Use Studiesmentioning

confidence: 99%

The Effectiveness of Nonprescription Drug Labels in the United States: Insights from Recent Research and Opportunities for the Future

Catlin

Brass

2018

Pharmacy

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“…As reported previously for SSS (2.9% MICs) [10], relatively few newly diagnosed MICs were identified during follow-up urological assessments. Moreover, MICs were identified with similar incidence in participants with and without positive dipstick findings in the two actual-use studies, the only possible exceptions being urinary tract infection and diabetes (Table 4).…”

Section: Discussionmentioning

confidence: 85%

“…We analyzed data from three observational studies involving men with a urine dipstick finding at study baseline: an SSS (no medication being dispensed) with urological assessment of predefined subpopulations [10]; an exploratory, 8-week actual-use study with OTC tamsulosin (AUS8; NCT01726270) [9]; and a 24-week actual-use study with OTC tamsulosin (AUS24; NCT02573311) [11]. Detailed methodologies of these studies have been described previously; each of them had been approved by an independent ethical committee [9–11].…”

Section: Methodsmentioning

confidence: 99%

Is Dipstick Urinalysis Screening Beneficial in Men with Lower Urinary Tract Symptoms?

et al. 2019

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IntroductionDipstick urinalysis is a widely used screening tool in the evaluation of men with lower urinary tract symptoms (LUTS) suggestive of benign prostatic hyperplasia (BPH). As limited data support the use of dipstick urinalysis, we have used data from three recently published studies to assess clinical outcomes in those who had dipstick urinalysis findings for blood, glucose, and/or leukocytes.MethodsWe analyzed data from three observational studies involving men interested in using over-the-counter tamsulosin: a self-selection study (SSS) and two actual-use studies of 8-week (AUS8) and 24-week (AUS24) durations. Subgroup analyses focused on pooled data from participants not using α-blockers or other prescription medication for LUTS suggestive of BPH (nonRx users) and who had urine dipstick findings. Data from participants using α-blockers (AUS8) or any prescription BPH medications (SSS and AUS24) are presented as reference.ResultsOverall, 2488 nonRx users underwent dipstick urinalysis and 680 (27.3%) had positive findings including traces of blood (332; 13.3%), glucose (259; 10.4%), and/or leukocytes (245; 9.8%). Among users of prescription medicines, 21.6% (37/171) in SSS, 27.4% (23/84) in AUS8, and 31.1% (47/151) in AUS24 had urine dipstick findings. The 200 dipstick-positive nonRx users in SSS underwent per protocol urological assessment: 26 (13.0%) had a newly diagnosed condition causing/contributing to urinary symptoms of which 2.9% were identified as medically important conditions. Among nonRx users with or without a dipstick finding, medically important conditions reported included prostate cancer (1.0% vs. 1.0%, respectively) and urolithiasis (1.0% vs. 0.3%, respectively). The proportion of men with dipstick urinalysis findings was similar between men who regularly visited their physician and those who did not.ConclusionDipstick urinalysis did not markedly increase the detection of undiagnosed medically important conditions that cause/contribute to urinary symptoms, suggesting that this test may not be a very effective screening tool for men with LUTS.FundingBoehringer Ingelheim Pharmaceuticals, Inc.Electronic Supplementary MaterialThe online version of this article (10.1007/s12325-019-01042-0) contains supplementary material, which is available to authorized users.

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“…The benefit of RWD to inform various aspects of drug development is well supported with great expectation for expanded utilization . The positive perspective for RWD and early evidence of improved decision making is largely realized by development strategies focused for the developed world (i.e., advanced economies with advanced technological infrastructure or high‐income countries (HICs)).…”

Section: Examples Of Rwd That Would Inform Global Health Research Andmentioning

confidence: 99%

Real‐World Data: An Unrealized Opportunity in Global Health?

Barrett

Heaton

2019

Clin Pharma and Therapeutics

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Feasibility of an Alternative Option for the Management of Male Lower Urinary Tract Symptoms

Cited by 8 publications

References 15 publications

The Effectiveness of Nonprescription Drug Labels in the United States: Insights from Recent Research and Opportunities for the Future

The Effectiveness of Nonprescription Drug Labels in the United States: Insights from Recent Research and Opportunities for the Future

Is Dipstick Urinalysis Screening Beneficial in Men with Lower Urinary Tract Symptoms?

Real‐World Data: An Unrealized Opportunity in Global Health?

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