Comparing UroLift Experience Against Rezūm

Benign Prostatic Hyperplasia Clinical Trial

— CLEAR  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04338776
• Other study ID #: CP00013
• Status: Recruiting
• Phase: N/A
• Start date: January 22, 2021
• Est. completion date: December 2025

Study information

• Verified date: November 2023
• Source: NeoTract, Inc.
• Contact: Cliff Kline
• Phone: 805-456-9653
• Email: cliff.kline[@]teleflex.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: December 2025
• Est. primary completion date: May 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 50 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Benign Prostatic Hyperplasia
• Hyperplasia
• Prostatic Hyperplasia

Intervention

Device:
• 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.
• Rezum
The Rezum™ System is intended to relieve symptoms, obstructions, and reduce prostate tissue associated with BPH. The Rezum System is manufactured by Boston Scientific and consists of a radiofrequency (RF) generator and a single-use transurethral delivery device. The Rezum 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.

Locations

Country	Name	City	State
United Kingdom	Frimley Park Hospital	Frimley	Camberley
United Kingdom	NORFOLK and Norwich University Hospital	Norwich	Norfolk
United States	Urology Austin	Austin	Texas
United States	UT Southwestern Medical Center	Dallas	Texas
United States	NYU Winthrop Urology	Garden City	New York
United States	Tower Urology	Los Angeles	California
United States	Weil Cornell Medical College, Cornell University	New York	New York
United States	Comprehensive Urology	Royal Oak	Michigan
United States	Urology San Antonio	San Antonio	Texas

Sponsors (1)

Lead Sponsor	Collaborator
NeoTract, Inc.

Countries where clinical trial is conducted

United States,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Catheter Independent	Number of subjects who are catheter independent and remain catheter independent through 1-week	Through 1-week