MP24-04 RANDOMIZED PLACEBO-CONTROLLED N-OF-1 TRIALS OF TAMSULOSIN FOR LOWER URINARY TRACT SYMPTOMS

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You have accessJournal of UrologyCME1 Apr 2023MP24-04 RANDOMIZED PLACEBO-CONTROLLED N-OF-1 TRIALS OF TAMSULOSIN FOR LOWER URINARY TRACT SYMPTOMS Kevin Li, Scott Bauer, Stacey Kenfield, Kaiwei Lu, Charles McCulloch, Michael Steinman, Akinyemi Oni-Orisan, Natalie Rios, Anthony Enriquez, and Benjamin Breyer Kevin LiKevin Li More articles by this author , Scott BauerScott Bauer More articles by this author , Stacey KenfieldStacey Kenfield More articles by this author , Kaiwei LuKaiwei Lu More articles by this author , Charles McCullochCharles McCulloch More articles by this author , Michael SteinmanMichael Steinman More articles by this author , Akinyemi Oni-OrisanAkinyemi Oni-Orisan More articles by this author , Natalie RiosNatalie Rios More articles by this author , Anthony EnriquezAnthony Enriquez More articles by this author , and Benjamin BreyerBenjamin Breyer More articles by this author View All Author Informationhttps://doi.org/10.1097/JU.0000000000003249.04AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract INTRODUCTION AND OBJECTIVE: Alpha blockers such as tamsulosin are considered 1st line for lower urinary tract symptoms (LUTS) due to benign prostatic hyperplasia (BPH). Despite widespread use, their efficacy versus placebo is modest/highly variable and adverse effects including orthostatic hypotension/falls in older men are costly. A personalized approach can identify patients in whom benefits outweigh harms and those who can be deprescribed without worsening LUTS or causing complications. METHODS: We conducted placebo-controlled N-of-1 trials in men ≥55 on tamsulosin ≥12 months for BPH. To ensure tolerance of tamsulosin discontinuation, all men completed a one week run-in without taking tamsulosin or study pills. Participants then completed 2 block-randomized cycles, each comprised of two 2-week treatment periods of tamsulosin/placebo separated by 1 week of washout on placebo, and completed daily symptom assessment on REDCap (International Prostate Symptom Score (IPSS) modified for 24 h recall). Linear mixed models adjusted for treatment period were used to calculate predicted random effects, representing the mean effect of tamsulosin for each participant. RESULTS: 30/71 eligible patients contacted were enrolled. 4 failed run-in and were excluded. The remaining 26 were grouped by mean change in daily IPSS on tamsulosin vs. placebo and categorized as minimal (11/26, 42%), moderate (11/26, 42%), or strong responders (4/26, 15%) based on preset cutoffs (Figure 1). Demographics, social/health-related behaviors, and medical history except coronary artery disease (p = 0.005) were similar across groups (Table 1). Responder groups significantly differed in perceived fatigue from LUTS (p=0.024) at baseline. CONCLUSIONS: It is feasible to conduct placebo-controlled N-of-1 trials in older men receiving tamsulosin using daily symptom reporting. Patients identified as minimal responders are candidates for deprescribing and alternative interventions. Source of Funding: UCSF-RAP © 2023 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 209Issue Supplement 4April 2023Page: e318 Advertisement Copyright & Permissions© 2023 by American Urological Association Education and Research, Inc.MetricsAuthor Information Kevin Li More articles by this author Scott Bauer More articles by this author Stacey Kenfield More articles by this author Kaiwei Lu More articles by this author Charles McCulloch More articles by this author Michael Steinman More articles by this author Akinyemi Oni-Orisan More articles by this author Natalie Rios More articles by this author Anthony Enriquez More articles by this author Benjamin Breyer More articles by this author Expand All Advertisement PDF downloadLoading ...