Comparing UroLift Experience Against Rezūm

NCT ID: NCT04338776

Last Updated: 2025-10-14

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-01-22
• Study Completion Date: 2025-12-31

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.

Conditions

Benign Prostatic Hyperplasia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

UroLift

Patient randomized to the UroLift arm will receive the FDA-approved UroLift procedure.

Group Type: EXPERIMENTAL

UroLift

Intervention Type: DEVICE

The UroLift System is indicated for the treatment of symptoms due to urinary outflow obstruction secondary to benign prostatic hyperplasia (BPH).

During the procedure, an implant is delivered into the prostatic lobe obstructing the urethra and restricting urine flow. The distal end of the device is used to compress the lobe then the implant is delivered to retain the lobe in position, thereby increasing the urethral opening and reducing the fluid obstruction through the prostatic urethra.

Rezūm

Patient randomized to the Rezūm arm will receive the FDA-approved Rezūm procedure.

Group Type: EXPERIMENTAL

Rezum

Intervention Type: DEVICE

The Rezūm™ System is intended to relieve symptoms, obstructions, and reduce prostate tissue associated with BPH.

The Rezūm System is manufactured by Boston Scientific and consists of a radiofrequency (RF) generator and a single-use transurethral delivery device.

The Rezūm System utilizes radiofrequency current to generate "wet" thermal energy in the form of water vapor, which is then injected into the transition zone and/or median lobe of the prostate tissue in controlled 9-second doses. The vapor that is injected into the prostate tissue rapidly disperses through the interstitial space between the tissue cells. As the vapor cools, it condenses immediately on contact with tissue and the stored thermal energy is released,reducing the volume tissue adjacent to the urethra.

Interventions

UroLift

The UroLift System is indicated for the treatment of symptoms due to urinary outflow obstruction secondary to benign prostatic hyperplasia (BPH).

During the procedure, an implant is delivered into the prostatic lobe obstructing the urethra and restricting urine flow. The distal end of the device is used to compress the lobe then the implant is delivered to retain the lobe in position, thereby increasing the urethral opening and reducing the fluid obstruction through the prostatic urethra.

Intervention Type: DEVICE

Rezum

The Rezūm™ System is intended to relieve symptoms, obstructions, and reduce prostate tissue associated with BPH.

The Rezūm System is manufactured by Boston Scientific and consists of a radiofrequency (RF) generator and a single-use transurethral delivery device.

The Rezūm System utilizes radiofrequency current to generate "wet" thermal energy in the form of water vapor, which is then injected into the transition zone and/or median lobe of the prostate tissue in controlled 9-second doses. The vapor that is injected into the prostate tissue rapidly disperses through the interstitial space between the tissue cells. As the vapor cools, it condenses immediately on contact with tissue and the stored thermal energy is released,reducing the volume tissue adjacent to the urethra.

Intervention Type: DEVICE

Eligibility Criteria

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

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

• Minimum Eligible Age: 50 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

NeoTract, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Tower Urology

Los Angeles, California, United States

Comprehensive Urology

Royal Oak, Michigan, United States

NYU Winthrop Urology

Garden City, New York, United States

Weil Cornell Medical College, Cornell University

New York, New York, United States

Urology Austin

Austin, Texas, 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

Cambridge University Hospitals NHS Foundation Trust

Cambridge, , United Kingdom

Countries

United States; United Kingdom

Other Identifiers

CP00013

Identifier Type: -

Identifier Source: org_study_id