Comparing UroLift Experience Against Rezūm (CLEAR)

NeoTract

Status: Active, not recruiting

Conditions: Benign Prostatic Hyperplasia

Treatments: Device: UroLift; Device: Rezum

Study type: Interventional

Funder types: Industry

Identifiers

NCT04338776

CP00013

Details and patient eligibility

About

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.

Full 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.

Enrollment: 120 estimated patients

Sex: Male

Ages: 50+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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120 participants in 2 patient groups

UroLift

Experimental group

Description:

Patient randomized to the UroLift arm will receive the FDA-approved UroLift procedure.

Treatment:

Device: UroLift

Rezūm

Experimental group

Description:

Patient randomized to the Rezūm arm will receive the FDA-approved Rezūm procedure.

Treatment:

Device: Rezum