Benign Prostatic Hyperplasia
Conditions
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.
Interventions
DEVICEUroLift
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.
DEVICERezum
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.
Sponsors
NeoTract, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
50 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Catheter Independent | Through 1-week | Number of subjects who are catheter independent and remain catheter independent through 1-week |
Countries
United Kingdom, United States
Outcome results
None listed