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

Blue Halo Biomedical, LLC

Status

Enrolling

Conditions

Urinary Retention

Treatments

Device: blue halo coil catheter

Study type

Interventional

Funder types

Other

Identifiers

NCT05714488

19-010.3

Details and patient eligibility

About

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.

Full 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.

Enrollment

95 estimated patients

Sex

Male

Ages

50+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion criteria

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