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

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

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.

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.

The Investigators are conducting a single-arm study with one-group posttest only design.Although this study is a non-randomized control trial, the one-arm design avoids selection and treatment diffusion (among other things). The comparator for the coil catheter is inferior and known to cause injury and infection. Therefore, researchers could not ethically randomly assign subjects to a control group that would receive the alternative device for the sake of comparison.

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.

device inserted with coil at the bladder and straight arm in the prostatic urethra proximal to the external sphincter

The primary effectiveness endpoint of the study is the number of subjects who were able to return to volitional voiding with a post void residual less then 75 cc during a 28-day study period.Post Void Residual will be measured by bladder ultrasound and reported as cc.

The primary safety endpoint is the number of subjects who had an adverse event related to the Coil Catheter and required removal of the Coil Catheter with an alternative method to drain the bladder, such as an indwelling Foley catheter, or self-intermittent catheterization.

The number of participants who experienced urinary obstruction secondary to migration of the Blue Halo Coil Catheter, and required replacement of the device

The number of participants who experienced clinically significant gross hematuria that necessitated removal of the Blue Halo Coil Catheter and placement of a Foley catheter for bladder drainage

Infection status at the time of insertion and removal of the device will be recorded during the study. Urine culture and sensitivity will be obtained prior to device insertion, at the 28 day removal, and at day 56 follow-up safety visit. The results will be reported as colony forming units, CFU, per ml. Asymptomatic colonization as well as symptomatic Urinary tract infection, UTI, will be reported.

Serum Creatinine measured as mg/dl will be measured prior to placement of the Blue Halo Coli Catheter, and repeated at the 28 day device removal and at the day 56 follow-up safety visit. This outcome is to observe if there are any changes in renal function that might be attributable to the device

The SF-8, Short Form- 8 question survey, will be recorded at the screening visit and the 28 day device removal, to observe any change in Quality of Life issues.

An IRB approved, 4 question, urinary symptom assessment will be recorded at the screening visit, at the 28 day device removal, and at the 56 day safety follow-ip visit.

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

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