Comparing UroLift Experience Against Rezūm

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Benign Prostatic Hyperplasia Genital Diseases Genital Diseases, Male Male Urogenital Diseases Prostatic Diseases Prostatic Hyperplasia Urogenital Diseases

Age range

50 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Frimley Park Hospital, Frimley, Camberley, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Male gender
Age ≥ 50 years
Diagnosis of symptomatic BPH
Prostate volume 30cm3 ≤ 80cm3
Willing to sign study informed consent form

Exclusion criteria

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

Treatment and study plan

Urolift

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.

Rezum

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.

Primary outcomes

Catheter Independent

Time frame: Through 1-week

Number of subjects who are catheter independent and remain catheter independent through 1-week

Sponsors and collaborators

Lead sponsor

NeoTract, Inc.

Industry

Registry information

Official study title

C.L.E.A.R. - Comparing UroLift Experience Against Rezūm

Acronym: CLEAR

Important dates

Study start: 2021
Primary completion: 2025
Study completion: 2025
First posted: Apr 8, 2020
Registry last updated: Oct 14, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Active, Not Recruiting