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

Status unconfirmed · Not applicable

Conditions studied: Urinary Retention

In brief

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.

Key facts

Study ID

NCT05714488

Run by

Blue Halo Biomedical, LLC

People needed

95

Starts

2022-08-01

Expected to finish

2024-10-01

Last updated by the study team

2024-01-10

Who can join

Age: 50 and older. Sex: male. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• The University of Alabama-Birmingham — Birmingham, Alabama, United States (enrolling)
• Mayo Clinic Arizona — Phoenix, Arizona, United States (enrolling)
• Florida Urology Partners — Brandon, Florida, United States (enrolling)
• Vero Urology Center — Vero Beach, Florida, United States (enrolling)

Full record on ClinicalTrials.gov

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