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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Urinary Retention

Intervention / Treatment
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* Device: blue halo coil catheter


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 50 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: 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.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: single arm study<br>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: blue halo coil catheter<br>* device inserted with coil at the bladder and straight arm in the prostatic urethra proximal to the external sphincter<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The change in Post Void Residual from baseline to day 28 will be measured and reported | 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. | 28 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Primary safety endpoint | 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. | 28 days | 
| Secondary Safety Endpoint 1 | The number of Blue Halo Coil Catheters that were visibly encrusted at the time of removal | 28 days | 
| Secondary Safety Endpoint 2 | The number of participants who experienced urinary obstruction secondary to migration of the Blue Halo Coil Catheter, and required replacement of the device | 28 days | 
| Secondary Safety Endpoint 3 | 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 | 28 days |