Evaluation of the "Blue Halo Coil Catheter" for Patients With Prostatic Obstruction
Purpose
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.
Condition
- Urinary Retention
Eligibility
- Eligible Ages
- Over 50 Years
- Eligible Genders
- Male
- Accepts Healthy Volunteers
- Yes
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
Study Design
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- N/A
- Intervention Model
- Single Group Assignment
- Intervention 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.
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Blue Halo Coil Catheter for Urinary Retention |
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. |
|
Recruiting Locations
Birmingham, Alabama 35205
More Details
- Status
- Recruiting
- Sponsor
- Blue Halo Biomedical, LLC
Detailed 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.