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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
120
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.
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.
Tower Urology
Los Angeles, California, United States
Comprehensive Urology
Royal Oak, Michigan, United States
NYU Winthrop Urology
Garden City, New York, United States
Catheter Independent
Number of subjects who are catheter independent and remain catheter independent through 1-week
Time frame: Through 1-week
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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