Ceasing Alpha-blockers Early After Resection of the Prostate (The CLEAR Trial)

Study acronym: CLEAR
StatusNot Yet Recruiting
PhasePhase 4
Started

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Record History

  1. Minor Study First Submitted
After surgery for benign prostatic hyperplasia (BPH) that physically removes the prostatic transition zone (such as TURP or laser enucleation), many men are routinely sent home with a 2- to 4-week prescription of an alpha-blocker (tamsulosin) to prevent urinary retention, even though the tissue targeted by the drug has been removed. Alpha-blockers can cause blood-pressure drops upon standing, fainting, and falls in older men. In this study, men who have successfully undergone BPH surgery and passed an initial voiding trial are randomly assigned to take either tamsulosin or an identical-looking placebo capsule once daily for 30 days. The study tests whether stopping the drug immediately does not increase the risk of needing a catheter again (non-inferiority), and whether stopping it reduces dizziness, fainting, and falls (superiority).
Trial Details
NCT Number NCT07846579
Lead Sponsor Shanghai East Hospital
Conditions
(from sponsor)
Benign Prostatic Hyperplasia
Related terms Hypotension, Orthostatic, Prostatic Hyperplasia
Enrollment 400 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov