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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
95
device inserted with coil at the bladder and straight arm in the prostatic urethra proximal to the external sphincter
The University of Alabama-Birmingham
Birmingham, Alabama, United States
RECRUITINGMayo Clinic Arizona
Phoenix, Arizona, United States
RECRUITINGFlorida Urology Partners
Brandon, Florida, United States
RECRUITINGThe 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.
Time frame: 28 days
Primary safety endpoint adverse event and device removal
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.
Time frame: 28 days
Secondary Safety Endpoint 1, incidence of device encrustation at removal
The number of Blue Halo Coil Catheters that were visibly encrusted at the time of removal
Time frame: 28 days
Secondary Safety Endpoint 2,urinary obstruction due to device migration
The number of participants who experienced urinary obstruction secondary to migration of the Blue Halo Coil Catheter, and required replacement of the device
Time frame: 28 days
Secondary Safety Endpoint 3, incidence of clinically significant hematuria
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
Time frame: 28 days
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Vero Urology Center
Vero Beach, Florida, United States
RECRUITING