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

Description

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.

Conditions

Urinary Retention

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Study Overview

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Study Details

Study overview

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.

Study: A Prospective Evaluation of the Blue Halo BioMedical, LLC "Blue Halo Coil Catheter" for Patients With Prostatic Obstruction

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

Condition
Urinary Retention
Intervention / Treatment

-

Contacts and Locations

Birmingham

The University of Alabama-Birmingham, Birmingham, Alabama, United States, 35205

Phoenix

Mayo Clinic Arizona, Phoenix, Arizona, United States, 85054

Brandon

Florida Urology Partners, Brandon, Florida, United States, 33511

Vero Beach

Vero Urology Center, Vero Beach, Florida, United States, 32960

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * 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

Ages Eligible for Study

50 Years to

Sexes Eligible for Study

MALE

Accepts Healthy Volunteers

Yes

Collaborators and Investigators

Blue Halo Biomedical, LLC,

Study Record Dates

2024-10-01