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Ceasing Alpha-blockers Early After Resection of the Prostate (The CLEAR Trial)
Sponsor: Shanghai East Hospital
Summary
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).
Official title: Ceasing aLpha-blockers Early After Resection of the Prostate (The CLEAR Trial): A Multicenter, Double-blind, Placebo-controlled, Non-inferiority and Nested Superiority Randomized Clinical Trial
Key Details
Gender
MALE
Age Range
50 Years - Any
Study Type
INTERVENTIONAL
Enrollment
400
Start Date
2026-12-01
Completion Date
2029-02-01
Last Updated
2026-09-29
Healthy Volunteers
No
Conditions
Interventions
Tamsulosin hydrochloride 0.2 mg
As per Arm B
Placebo
Matching placebo capsule, visually and organoleptically indistinguishable from the active capsules; identical packaging and labelling with a unique medication ID number.