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

Urinary Retention Clinical Trial

— BlueHaloCoil  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05714488
• Other study ID #: 19-010.3
• Status: Recruiting
• Phase: N/A
• Start date: August 1, 2022
• Est. completion date: October 1, 2024

Study information

• Verified date: January 2024
• Source: Blue Halo Biomedical, LLC
• Contact: GAMEEL B HODGE, MD
• Phone: 407-492-1683
• Email: bhodge[@]bluehalobiomedical.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 95
• Est. completion date: October 1, 2024
• Est. primary completion date: September 1, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 50 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Urinary Retention

Intervention

Device:
• blue halo coil catheter
device inserted with coil at the bladder and straight arm in the prostatic urethra proximal to the external sphincter

Locations

Country	Name	City	State
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	Vero Urology Center	Vero Beach	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Blue Halo Biomedical, LLC

Country where clinical trial is conducted

United States, 

References & Publications (11)

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 — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Fontanarosa PB, Roush WR. Acute urinary retention. Emerg Med Clin North Am. 1988 Aug;6(3):419-37. — View 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. — View Citation

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. — View Citation

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. — View 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. — View Citation

Williams G. Stents in the lower urinary tract. European Urology Update Series 1992. Vol l (1), p 82-87.

* Note: There are 11 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	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
Other	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
Other	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
Primary	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	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	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	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	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