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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| UroLift | Experimental | Patient randomized to the UroLift arm will receive the FDA-approved UroLift procedure. |
|
| Rezūm | Experimental | Patient randomized to the Rezūm arm will receive the FDA-approved Rezūm procedure. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Catheter Independent | Number of subjects who are catheter independent and remain catheter independent through 1-week | Through 1-week |
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Inclusion Criteria:
Exclusion Criteria:
Patients must be male. The study is evaluation the population of men diagnosed with benign prostatic hyperplasia.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tower Urology | Los Angeles | California | 90048 | United States | ||
| Comprehensive Urology |
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| ID | Term |
|---|---|
| D011470 | Prostatic Hyperplasia |
| ID | Term |
|---|---|
| D011469 | Prostatic Diseases |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
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| 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. |
|
| Royal Oak |
| Michigan |
| 48073 |
| United States |
| NYU Winthrop Urology | Garden City | New York | 11530 | United States |
| Weil Cornell Medical College, Cornell University | New York | New York | 10065 | United States |
| Urology Austin | Austin | Texas | 78759 | United States |
| UT Southwestern Medical Center | Dallas | Texas | 75048 | United States |
| Urology San Antonio | San Antonio | Texas | 78229 | United States |
| Frimley Park Hospital | Frimley | Camberley | 6U167UJ UK | United Kingdom |
| NORFOLK and Norwich University Hospital | Norwich | Norfolk | NR4 7UY | United Kingdom |
| Cambridge University Hospitals NHS Foundation Trust | Cambridge | CB2 0QQ | United Kingdom |
| D052801 |
| Male Urogenital Diseases |