drugset / Trial / NCT04987892

Investigating Medication vs. Prostatic Urethral Lift: Assessment and Comparison of Therapies for BPH

NCT04987892

Phase 4 Unknown 250 enrolled NeoTract, Inc.
RandomizedParallel-groupOpen-labelTreatment

Summary

This prospective, multicenter, two-arm, 1:1 randomized controlled trial (RCT) will enroll approximately 250 males at approximately 25 sites located within the United States. All enrolled subjects will be 45 years of age or older diagnosed with symptomatic benign prostatic hyperplasia (BPH). They will be randomized to one of two readily available, marketed BPH therapies; Prostatic Urethral Lift procedure with the UroLift System (PUL Arm) or 0.4mg tamsulosin HCl (MED Arm).

Timeline

Start
2021-12-06
Primary completion
2025-05
Completion
2025-10

Drugs

EvaluationDrugModalityDoseRoute
Comparator Tamsulosin Other / unclassified 0.4 mg