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

Study: A Prospective Evaluation of the Blue Halo BioMedical, LLC "Blue Halo Coil Catheter" for Patients With Prostatic Obstruction

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.

Study Overview

• Status: Recruiting
• Conditions: Urinary Retention
• Intervention / Treatment: Device: blue halo coil catheter

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 Type: Interventional
• Enrollment (Estimated): 95
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: GAMEEL B HODGE, MD; Phone Number: 407-492-1683; Email: bhodge@bluehalobiomedical.com
• Study Contact Backup: Name: GAINES W HAMMOND, MD; Phone Number: 254-652-2475; Email: gwhoffice@gmail.com

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35205
      • Recruiting
      • The University of Alabama-Birmingham
      • Contact: Brandon A Young, BS; Phone Number: 205-908-7315; Email: bayoung@uabmc.edu
      • Contact: Jane E S Vines, MPH,MSN,RN,CCRP; Phone Number: 205-224-7324; Email: jsnowden@uabmc.edu
      • Principal Investigator: Adam Baumgarten, MD,MBA
      • Sub-Investigator: James Bryant, MD
  • Arizona
    • Phoenix, Arizona, United States, 85054
      • Recruiting
      • Mayo Clinic Arizona
      • Principal Investigator: Mitchell Humphreys, MD
      • Contact: Debbie Ryan; Phone Number: 480-342-1208; Email: ryan.debra29@mayo.edu
      • Sub-Investigator: Scott Cheney, MD
  • Florida
    • Brandon, Florida, United States, 33511
      • Recruiting
      • Florida Urology Partners
      • Contact: James E Alver, MD; Phone Number: 813-685-0827; Email: alverje@gmail.com
    • Vero Beach, Florida, United States, 32960
      • Recruiting
      • Vero Urology Center
      • Contact: JOHN R ATWELL, MD; Phone Number: 772-569-7606; Email: j.atwell@verourology.com
      • Contact: Andrew Prestini, PA-C; Phone Number: 772-569-7606; Email: a.prestini@verourology.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Device: blue halo coil catheter; device inserted with coil at the bladder and straight arm in the prostatic urethra proximal to the external sphincter

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The 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.	28 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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	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	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	28 days

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Bacterial Infection Monitoring	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.	56 days
Trends in Renal Function	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	56 days
Quality of Life Measurement, no scale to report	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.	28 days
Urinary Bother Inventory, no scale to report	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.	56 days

Collaborators and Investigators

• Sponsor: Blue Halo Biomedical, LLC

Publications and helpful links

General Publications

• Feneley RC, Hopley IB, Wells PN. Urinary catheters: history, current status, adverse events and research agenda. J Med Eng Technol. 2015;39(8):459-70. doi: 10.3109/03091902.2015.1085600. Epub 2015 Sep 18. Erratum In: J Med Eng Technol. 2016;40(2):59.
• Fontanarosa PB, Roush WR. Acute urinary retention. Emerg Med Clin North Am. 1988 Aug;6(3):419-37.
• Samm BJ, Dmochowski RR. Urologic emergencies. Conditions affecting the kidney, ureter, bladder, prostate, and urethra. Postgrad Med. 1996 Oct;100(4):177-80, 183-4. doi: 10.3810/pgm.1996.10.100.
• Andersen JT, Nickel JC, Marshall VR, Schulman CC, Boyle P. Finasteride significantly reduces acute urinary retention and need for surgery in patients with symptomatic benign prostatic hyperplasia. Urology. 1997 Jun;49(6):839-45. doi: 10.1016/s0090-4295(97)00185-4.
• de la Rosette JJ, Beerlage HP, Debruyne FM. Role of temporary stents in alternative treatment of benign prostatic hyperplasia. J Endourol. 1997 Dec;11(6):467-72. doi: 10.1089/end.1997.11.467.
• Williams G. Stents in the lower urinary tract. European Urology Update Series 1992. Vol l (1), p 82-87.
• Devonec M, Dahlstrand C. Temporary urethral stenting after high-energy transurethral microwave thermotherapy of the prostate. World J Urol. 1998;16(2):120-3. doi: 10.1007/s003450050037.
• Hammond, G. A Prospective Evaluation of the Catheter Science M3 "Mini Catheter" for Patients with Prostatic Obstruction. AUA Poster Presentation MP73-06, San Francisco, California, May, 2018
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2022
• Primary Completion (Estimated): September 1, 2024
• Study Completion (Estimated): October 1, 2024

Study Registration Dates

• First Submitted: September 20, 2022
• First Submitted That Met QC Criteria: January 26, 2023
• First Posted (Actual): February 6, 2023

Study Record Updates

• Last Update Posted (Actual): January 10, 2024
• Last Update Submitted That Met QC Criteria: January 8, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urologic Diseases; Urination Disorders; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Urinary Retention
• Other Study ID Numbers: 19-010.3

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: any Adverse Event (AE), Unanticipated AE will be shared with other researchers
• IPD Sharing Time Frame: within 5 days of event and for duration of the study
• IPD Sharing Access Criteria: all investigators will be emailed by the sponsor with the Adverse Event shared information
• IPD Sharing Supporting Information Type: CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes