drugset / Trial / NCT07846579

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

NCT07846579 ↗

Phase 4 Not yet recruiting 400 enrolled Shanghai East Hospital
RandomizedParallel-groupQuadruple-blindTreatment

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).

Timeline

Start
2026-12-01
Primary completion
2028-12-01
Completion
2029-02-01

Drugs

EvaluationDrugModalityDoseRoute
Comparator Tamsulosin Other / unclassified 0.2 mg Oral