Comparing UroLift Experience Against Rezūm

Not Applicable

Recruiting

• Conditions: Benign Prostatic Hyperplasia
• Interventions: Device: UroLift; Device: Rezum

• Registration Number: NCT04338776
• Lead Sponsor: NeoTract, Inc.

Brief Summary

C.L.E.A.R. Study is poised to compare the patient experience post procedure, including catheterization needs as well as retreatment and BPH medication rates following treatment with either the UroLift® System or Rezūm™ System through 12 months.

Detailed Description

Patients will be randomized to either the UroLift or Rezum arm. Post-procedure, subjects who receive a catheter between post-procedure and prior to discharge, will return to office to complete a voiding assessment.

All subjects will be expected to complete questionnaires and assessments, as part of SOC (varies by institution), at day 3, day 7, 2 weeks, 1 month, 3 months and 12 months post-procedure.

Study Timeline

• Study First Submitted: 2020-04-02
• Study First Submitted QC: 2020-04-06
• Study First Posted: 2020-04-08
• Study Start: 2021-01-22
• Status Verified: 2023-11
• Last Update Submitted: 2024-05-01
• Last Update Posted: 2024-05-03
• Primary Completion: 2025-05
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Male
• Target Recruitment: 120

Inclusion Criteria

1. Male gender
2. Age ≥ 50 years
3. Diagnosis of symptomatic BPH
4. Prostate volume 30cm3 ≤ 80cm3
5. Willing to sign study informed consent form

Read More

Exclusion Criteria

1. Current urinary tract infection
2. Current catheter dependent urinary retention or PVR >= 500 mL
3. Urethra conditions that may prevent insertion of delivery system into bladder
4. Previous BPH surgical procedure
5. Urinary incontinence presumed due to incompetent sphincter
6. Current gross hematuria
7. Patients with a urinary sphincter implant
8. Patients who have a penile prosthesis
9. Currently enrolled in any other investigational clinical research trial that has not completed the primary endpoint

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
UroLift	UroLift	Patient randomized to the UroLift arm will receive the FDA-approved UroLift procedure.
Rezūm	Rezum	Patient randomized to the Rezūm arm will receive the FDA-approved Rezūm procedure.

Primary Outcome Measures

Name	Time	Method
Catheter Independent	Through 1-week	Number of subjects who are catheter independent and remain catheter independent through 1-week

Trial Locations

Locations (9)

NYU Winthrop Urology; 🇺🇸 Garden City, New York, United States

Weil Cornell Medical College, Cornell University; 🇺🇸 New York, New York, United States

Comprehensive Urology; 🇺🇸 Royal Oak, Michigan, United States

Tower Urology; 🇺🇸 Los Angeles, California, United States

UT Southwestern Medical Center; 🇺🇸 Dallas, Texas, United States

Urology San Antonio; 🇺🇸 San Antonio, Texas, United States

Frimley Park Hospital; 🇬🇧 Frimley, Camberley, United Kingdom

NORFOLK and Norwich University Hospital; 🇬🇧 Norwich, Norfolk, United Kingdom

Urology Austin; 🇺🇸 Austin, Texas, United States