drugset / Trial / NCT04987892
Investigating Medication vs. Prostatic Urethral Lift: Assessment and Comparison of Therapies for BPH
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Tamsulosin | Other / unclassified | 0.4 mg | — |