Evaluation of the "Blue Halo Coil Catheter" for Patients With Prostatic Obstruction
NCT ID: NCT05714488
Last Updated: 2024-01-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
95 participants
INTERVENTIONAL
2022-08-01
2024-10-01
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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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.
blue halo coil catheter
device inserted with coil at the bladder and straight arm in the prostatic urethra proximal to the external sphincter
Interventions
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blue halo coil catheter
device inserted with coil at the bladder and straight arm in the prostatic urethra proximal to the external sphincter
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
50 Years
MALE
Yes
Sponsors
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Blue Halo Biomedical, LLC
OTHER
Responsible Party
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Locations
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The University of Alabama-Birmingham
Birmingham, Alabama, United States
Mayo Clinic Arizona
Phoenix, Arizona, United States
Florida Urology Partners
Brandon, Florida, United States
Vero Urology Center
Vero Beach, Florida, United States
Countries
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Central Contacts
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Facility Contacts
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References
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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.
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.
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.
Other Identifiers
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19-010.3
Identifier Type: -
Identifier Source: org_study_id
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