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

Not Applicable

Recruiting

• Conditions: Urinary Retention
• Interventions: Device: blue halo coil catheter

• Registration Number: NCT05714488
• Lead Sponsor: Blue Halo Biomedical, LLC

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.

Study Timeline

• Study Start: 2022-08-01
• Study First Submitted: 2022-09-20
• Study First Submitted QC: 2023-01-26
• Study First Posted: 2023-02-06
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-08
• Last Update Posted: 2024-01-10
• Primary Completion: 2024-09-01
• Study Completion: 2024-10-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Male
• Target Recruitment: 95

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Blue Halo Coil Catheter for Urinary Retention	blue halo coil catheter	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.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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
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.

Trial Locations

Locations (4)

Vero Urology Center; 🇺🇸 Vero Beach, Florida, United States

The University of Alabama-Birmingham; 🇺🇸 Birmingham, Alabama, United States

Florida Urology Partners; 🇺🇸 Brandon, Florida, United States

Mayo Clinic Arizona; 🇺🇸 Phoenix, Arizona, United States