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

NCT04987892 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 250

Last updated 2023-04-25

No results posted yet for this study

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).

Conditions

  • BPH

Interventions

DEVICE

UroLift System

Prostatic lift

DRUG

Tamsulosin Hydrochloride

Tamsulosin HCl 0.4mg

Sponsors & Collaborators

  • NeoTract, Inc.

    lead INDUSTRY

Principal Investigators

  • Claus Roehrborn, M.D. · University of Texas Southwestern Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
45 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-12-06
Primary Completion
2025-05-31
Completion
2025-10-31
FDA Drug
Yes
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04987892 on ClinicalTrials.gov