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

NCT05714488 | Unknown DMC FDA Device

• 1 other identifier: 19-010.3
• Study Type: interventional
• Target: 95
• Locations: 1 country
• Sites: 4

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.

Conditions

Urinary Retention

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Primary safety endpoint adverse event and device removal

  28 days

• Secondary Safety Endpoint 1, incidence of device encrustation at removal

  28 days

• Secondary Safety Endpoint 2,urinary obstruction due to device migration

  28 days

• Secondary Safety Endpoint 3, incidence of clinically significant hematuria

  28 days

Other Outcomes (4)

• Bacterial Infection Monitoring

  56 days

• Trends in Renal Function

  56 days

• Quality of Life Measurement, no scale to report

  28 days

Study Arms (1)

Blue Halo Coil Catheter for Urinary Retention

EXPERIMENTAL

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

Interventions

blue halo coil catheter DEVICE

device inserted with coil at the bladder and straight arm in the prostatic urethra proximal to the external sphincter

Blue Halo Coil Catheter for Urinary Retention

Eligibility Criteria

• Age: 50 Years+
• Gender Eligibility Details: biological males with BPH
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Blue Halo Biomedical, LLC: lead

Study Sites (4)

The University of Alabama-Birmingham

Birmingham, Alabama, 35205, United States

RECRUITING

Mayo Clinic Arizona

Phoenix, Arizona, 85054, United States

RECRUITING

Florida Urology Partners

Brandon, Florida, 33511, United States

RECRUITING

Vero Urology Center

Vero Beach, Florida, 32960, United States

RECRUITING

Related Publications (11)

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

  PMID: 3292220 RESULT

• 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.

  PMID: 8858090 RESULT

• 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.

  PMID: 9187688 RESULT

• 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.

  PMID: 9440858 RESULT

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

  RESULT

• 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.

  PMID: 12073225 RESULT

• 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.

  PMID: 26383168 RESULT

• 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

  RESULT

• 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.

  PMID: 30410822 RESULT

• 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.

  PMID: 17162043 RESULT

• 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.

  PMID: 17296408 RESULT

MeSH Terms

Conditions

Urinary Retention

Condition Hierarchy (Ancestors)

Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Central Study Contacts

GAMEEL B HODGE, MD

CONTACT

407-492-1683; bhodge@bluehalobiomedical.com

GAINES W HAMMOND, MD

CONTACT

254-652-2475; gwhoffice@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: September 20, 2022
• First Posted: February 6, 2023
• Study Start: August 1, 2022
• Primary Completion: September 1, 2024
• Study Completion: October 1, 2024
• Last Updated: January 10, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: CSR
• Time Frame: within 5 days of event and for duration of the study
• Access Criteria: all investigators will be emailed by the sponsor with the Adverse Event shared information

Locations

US (4)