Clinical trial NCT05714488: Evaluation of the "Blue Halo Coil Catheter" for Patients With Prostatic Obstruction
Official title: Study: A Prospective Evaluation of the Blue Halo BioMedical, LLC "Blue Halo Coil Catheter" for Patients With Prostatic Obstruction
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Urinary Retention
Lead sponsor: Blue Halo Biomedical, LLC
Sponsor class: OTHER
First posted: 2023-02-06
Enrollment: 95
Sex: MALE
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
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

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.

Eligibility criteria: 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

Primary outcomes:
measure: The change in Post Void Residual from baseline to day 28 will be measured and reported
timeFrame: 28 days
Secondary outcomes:
measure: Primary safety endpoint adverse event and device removal
timeFrame: 28 days
measure: Secondary Safety Endpoint 1, incidence of device encrustation at removal
timeFrame: 28 days
measure: Secondary Safety Endpoint 2,urinary obstruction due to device migration
timeFrame: 28 days
measure: Secondary Safety Endpoint 3, incidence of clinically significant hematuria
timeFrame: 28 days
Other outcomes:
measure: Bacterial Infection Monitoring
timeFrame: 56 days
measure: Trends in Renal Function
timeFrame: 56 days
measure: Quality of Life Measurement, no scale to report
timeFrame: 28 days
measure: Urinary Bother Inventory, no scale to report
timeFrame: 56 days
Locations:
city: Birmingham
country: United States
facility: The University of Alabama-Birmingham
state: Alabama
city: Phoenix
country: United States
facility: Mayo Clinic Arizona
state: Arizona
city: Brandon
country: United States
facility: Florida Urology Partners
state: Florida
city: Vero Beach
country: United States
facility: Vero Urology Center
state: Florida
Study officials:
References:
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citation: Sabharwal S, Sabharwal S. Using Temporary Prostatic Stents to Eliminate Bacterial Colonization in Men with Chronic Indwelling Catheters: A Pilot Study. Cureus. 2018 Aug 16;10(8):e3152. doi: 10.7759/cureus.3152.
citation: Garcia MM, Gulati S, Liepmann D, Stackhouse GB, Greene K, Stoller ML. Traditional Foley drainage systems--do they drain the bladder? J Urol. 2007 Jan;177(1):203-7; discussion 207. doi: 10.1016/j.juro.2006.08.101.
citation: Shore ND, Dineen MK, Saslawsky MJ, Lumerman JH, Corica AP. A temporary intraurethral prostatic stent relieves prostatic obstruction following transurethral microwave thermotherapy. J Urol. 2007 Mar;177(3):1040-6. doi: 10.1016/j.juro.2006.10.059.