Comparing UroLift Experience Against Rezūm

Last updated: February 19, 2025
Sponsor: NeoTract, Inc.
Overall Status: Active - Not Recruiting

Phase

N/A

Condition

Prostate Disorders

Bladder Disorders

Treatment

Rezum

UroLift

Clinical Study ID

NCT04338776
CP00013
  • Ages > 50
  • Male
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

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

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 notcompleted the primary endpoint

Study Design

Total Participants: 120
Treatment Group(s): 2
Primary Treatment: Rezum
Phase:
Study Start date:
January 22, 2021
Estimated Completion Date:
December 31, 2025

Study 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.

Connect with a study center

  • Frimley Park Hospital

    Frimley, Camberley 6U167UJ UK
    United Kingdom

    Site Not Available

  • NORFOLK and Norwich University Hospital

    Norwich, Norfolk NR4 7UY
    United Kingdom

    Site Not Available

  • Cambridge University Hospitals NHS Foundation Trust

    Cambridge, CB2 0QQ
    United Kingdom

    Site Not Available

  • Tower Urology

    Los Angeles, California 90048
    United States

    Site Not Available

  • Comprehensive Urology

    Royal Oak, Michigan 48073
    United States

    Site Not Available

  • NYU Winthrop Urology

    Garden City, New York 11530
    United States

    Site Not Available

  • Weil Cornell Medical College, Cornell University

    New York, New York 10065
    United States

    Site Not Available

  • Urology Austin

    Austin, Texas 78759
    United States

    Site Not Available

  • UT Southwestern Medical Center

    Dallas, Texas 75048
    United States

    Site Not Available

  • Urology San Antonio

    San Antonio, Texas 78229
    United States

    Site Not Available

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