Urinary Retention
Conditions
Brief summary
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
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.
Interventions
DEVICEblue halo coil catheter
device inserted with coil at the bladder and straight arm in the prostatic urethra proximal to the external sphincter
Sponsors
Blue Halo Biomedical, LLC
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
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.
Eligibility
Sex/Gender
MALE
Age
50 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The change in Post Void Residual from baseline to day 28 will be measured and reported | 28 days | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Primary safety endpoint adverse event and device removal | 28 days | 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. |
| Secondary Safety Endpoint 1, incidence of device encrustation at removal | 28 days | The number of Blue Halo Coil Catheters that were visibly encrusted at the time of removal |
| Secondary Safety Endpoint 2,urinary obstruction due to device migration | 28 days | The number of participants who experienced urinary obstruction secondary to migration of the Blue Halo Coil Catheter, and required replacement of the device |
| Secondary Safety Endpoint 3, incidence of clinically significant hematuria | 28 days | 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 |
Other
| Measure | Time frame | Description |
|---|---|---|
| Trends in Renal Function | 56 days | 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 |
| Quality of Life Measurement, no scale to report | 28 days | 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. |
| Urinary Bother Inventory, no scale to report | 56 days | 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. |
| Bacterial Infection Monitoring | 56 days | 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. |
Countries
United States
Contacts
Primary ContactGAMEEL B HODGE, MD
Backup ContactGAINES W HAMMOND, MD
Outcome results
None listed