NCT04987892

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

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

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 250 (estimated)
• Sponsor: NeoTract, Inc. · Industry
• Sex: Male
• Age: 45 Years
• Healthy volunteers: Accepted

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).

Detailed description

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).Men 45 or older diagnosed with symptomatic benign prostatic hyperplasia (BPH). BPH symptoms may range from mild (8) to severe (35) on the IPSS scale. All enrolled men must meet selection criteria and be candidates for therapy with both UroLift System and 0.4 mg tamsulosin HCl.

Conditions

• BPH

Interventions

Type	Name	Description
DEVICE	UroLift System	Prostatic lift
DRUG	Tamsulosin Hydrochloride	Tamsulosin HCl 0.4mg

Timeline

• Start date: 2021-12-06
• Primary completion: 2025-05-01
• Completion: 2025-10-01
• First posted: 2021-08-03
• Last updated: 2023-04-25

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study
• FDA-regulated device study