Blue Halo Coil Catheter for Urinary Retention

(BlueHaloCoil Trial)

Recruiting at 5 trial locations

Overseen By GAINES W HAMMOND, MD

Age: 18+

Sex: Male

Trial Phase: Academic

Sponsor: Blue Halo Biomedical, LLC

Must be taking: Alpha-blockers, 5-alpha-reductase inhibitors

Must not be taking: LHRH analogs, Anti-androgens

Disqualifiers: Prostate cancer, Cognitive impairment, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

Duration: 4 weeks

95 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial studies a special tube called the Blue Halo Coil Catheter, designed to help men with an enlarged prostate who have trouble urinating. The device helps drain the bladder more effectively and is used temporarily for a few weeks.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, if you are taking LHRH analogs or anti-androgen drugs, you cannot participate in the trial.

What data supports the effectiveness of the Blue Halo Coil Catheter treatment for urinary retention?

The research suggests that alternative techniques like the prostatic coil can be effective for patients with urinary retention, as they avoid the complications associated with long-term use of traditional catheters. A study showed that a similar coil was successfully positioned in 21 out of 25 patients on the first attempt, indicating a promising success rate. ^{1 2 3 4 5}

Is the Blue Halo Coil Catheter safe for humans?

The Blue Halo Coil Catheter is considered a safe alternative for patients with urinary retention who are not suitable for surgery, as it avoids the need for permanent catheters, which can cause complications like infections. ^{3 5 6 7 8}

How does the Blue Halo Coil Catheter treatment differ from other treatments for urinary retention?

The Blue Halo Coil Catheter is unique because it offers an alternative to traditional indwelling catheters by using a coil that can be placed with the help of transrectal sonography, potentially reducing the need for permanent catheters and surgery. This approach may allow patients to void naturally and maintain continence, which is not always possible with standard catheters. ^{2 5 9 10 11}

Eligibility Criteria

Men over 50 with urinary retention due to BPH, who have a post void residual >350cc and prostate volume >50cc or urethral length of 5+ cm. They must be able to consent and attend appointments. Excluded are those with urethral strictures, gross hematuria, cognitive impairments, history of prostate cancer, high PSA density (>0.1), or on certain prostate medications.

Inclusion Criteria

I have trouble fully emptying my bladder, leaving more than 350 cc.

Able to provide consent

I am a man over 50 years old.

Exclusion Criteria

Inability to undergo bladder catheterization (i.e. urethral stricture)

I have visible blood in my urine.

Subject with a PSA > 10 ng/ml

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Treatment

Participants receive the Blue Halo Coil Catheter for bladder drainage for up to 28 days

4 weeks

Device insertion and monitoring visits

Follow-up

Participants are monitored for safety and effectiveness after device removal

4 weeks

1 visit (in-person) at day 56

Treatment Details

Interventions

• Blue Halo Coil Catheter

Trial Overview The trial is testing the 'Blue Halo Coil Catheter' in men who can't empty their bladders fully because of an enlarged prostate (BPH). The goal is for participants to resume normal urination with less than 75 cc left after voiding.

Participant Groups

Group I: Blue Halo Coil Catheter for Urinary Retention Experimental Treatment 1 Intervention

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.

Who Is Running the Clinical Trial?

Blue Halo Biomedical, LLC

Lead Sponsor

Trials

1

Recruited

100+

Findings from Research

The use of Foley catheters, while common for indwelling bladder drainage, is associated with serious complications such as infections, kidney damage, and significant healthcare costs, amounting to £1.0-2.5 billion annually in the UK and approximately 2100 deaths per year.

There is an urgent need for a new indwelling catheter system that is safer and more effective, with features that allow for easy insertion, reliable retention, and natural bladder function, to reduce the risks associated with current catheter use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Urinary catheters: history, current status, adverse events and research agenda. Feneley, RC., Hopley, IB., Wells, PN.[2022]

From 2007 to 2010, the incidence of acute urinary retention (AUR) associated with benign prostatic hyperplasia (BPH) increased significantly among men aged 50 and older, rising from 4.00 to 5.23 per 1000 emergency room visits.

The study found that both primary and secondary AUR diagnoses increased by 25% and 80%, respectively, indicating a growing concern for BPH-related complications in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The incidence of acute urinary retention secondary to BPH is increasing among California men. Groves, HK., Chang, D., Palazzi, K., et al.[2013]

References

1. England pubmed.ncbi.nlm.nih.gov

The burden of prolonged indwelling catheter after acute urinary retention in Ikeja - Lagos, Nigeria. [2018]

2. England pubmed.ncbi.nlm.nih.gov

Urinary catheters: history, current status, adverse events and research agenda. [2022]

3. England pubmed.ncbi.nlm.nih.gov

Complications of urinary tract infections associated with devices used for long-term bladder management. [2019]

4. England pubmed.ncbi.nlm.nih.gov

A simple method for insertion of an intraprostatic coil. [2019]

5. Switzerland pubmed.ncbi.nlm.nih.gov

Use of transrectal longitudinal sonography in the placement of a prostatic coil. [2019]

6. Russia (Federation) pubmed.ncbi.nlm.nih.gov

[Efficacy and safety of intermittent catheterization for acute urinary retention: a prospective comparative randomized study]. [2023]

7. England pubmed.ncbi.nlm.nih.gov

The incidence of acute urinary retention secondary to BPH is increasing among California men. [2013]

8. England pubmed.ncbi.nlm.nih.gov

Management of acute urinary retention: a worldwide survey of 6074 men with benign prostatic hyperplasia. [2021]

9. England pubmed.ncbi.nlm.nih.gov

Acute urinary retention: which catheter? [2018]

10. England pubmed.ncbi.nlm.nih.gov

A new self-retaining intraurethral device. An alternative to an indwelling catheter in patients with urinary retention due to infravesical obstruction. [2019]

11. United States pubmed.ncbi.nlm.nih.gov

Self-retaining intraurethral stent: an alternative to long-term indwelling catheters or surgery in the treatment of prostatism. [2008]