Evaluation of the "Blue Halo Coil Catheter" for Patients With Prostatic Obstruction

Last updated: January 8, 2024
Sponsor: Blue Halo Biomedical, LLC
Overall Status: Active - Recruiting

Phase

N/A

Condition

Urinary Incontinence

Enuresis

Genitourinary Prolapse

Treatment

blue halo coil catheter

Clinical Study ID

NCT05714488
19-010.3
  • Ages > 50
  • Male
  • Accepts Healthy Volunteers

Study Summary

The Investigators will study a device for men in urinary retention secondary to Benign Prostatic Hyperplasia, BPH ,who are catheter dependent or who have a Post Void Residual > 350cc. The hypothesis is that the device will allow these participants to return to volitional voiding with a Post Void Residual <75 cc.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Male subjects > 50 years of age

  • Able to provide consent

  • Participants in urinary retention with post void residual > 350 cc

  • Urinary retention is due to BPH with a prostate volume > 50cc or a prostatic urethral length of 5+ cm

  • Subjects with a PSA > 4 ng/ml and a PSA density of 0.1 or less

  • Subjects on alpha- blocking drugs or 5-alpha-reductase inhibitor drugs may be included

Exclusion Criteria

  • Inability to undergo bladder catheterization ( i.e. urethral stricture)

  • Presence of gross hematuria

  • Lack of cognitive ability to give consent or keep appointments

  • History of Prostate Cancer

  • Subject with a PSA > 4 ng/ml and a PSA density of > 0.1 will require prostate biopsy to rule out prostate cancer in order to be considered for study enrollment

  • A subject with a prostate nodule will require biopsy to exclude cancer diagnosis

  • Subject with a PSA > 10 ng/ml

  • Subject taking LHRH analogs or anti-androgen drugs

Study Design

Total Participants: 95
Treatment Group(s): 1
Primary Treatment: blue halo coil catheter
Phase:
Study Start date:
August 01, 2022
Estimated Completion Date:
October 01, 2024

Study Description

The indication for use of the Blue Halo Coil Catheter is to facilitate bladder drainage in adult male patients with urinary retention due to benign prostatic hyperplasia. The device is inserted for temporary use up to 28 days.

Study participants will have a history of Foley catheter use or self-catheterization to drain their bladder.Participants may include men in urinary retention with no prior intervention.

The hypothesis is that the Blue Halo Coil Catheter will reduce the post void residual to <75 cc with volitional voiding.

The Blue Halo Coil Catheter is comprised of a Coiled Retention portion with a guidewire accommodating tip, a short prostate catheter segment, and a pusher/delivery catheter segment, that when left in place allows for the temporary collection of urine prior to conversion to short segment without an external collection device. The tip of the Blue Halo Coil Catheter utilizes a horizontal coil retention device. A monofilament suture is attached to the prostate catheter segment to allow for ease of positioning and removal. The suture also allows for repositioning should the device slip back into the bladder.

Connect with a study center

  • The University of Alabama-Birmingham

    Birmingham, Alabama 35205
    United States

    Active - Recruiting

  • Mayo Clinic Arizona

    Phoenix, Arizona 85054
    United States

    Active - Recruiting

  • Florida Urology Partners

    Brandon, Florida 33511
    United States

    Active - Recruiting

  • Florida Urology Partners

    Riverview, Florida 33578
    United States

    Site Not Available

  • Vero Urology Center

    Vero Beach, Florida 32960
    United States

    Active - Recruiting

  • Urology Clinics of North Texas

    Dallas, Texas 75231
    United States

    Site Not Available

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