95 Participants Needed

Blue Halo Coil Catheter for Urinary Retention

(BlueHaloCoil Trial)

Recruiting at 5 trial locations
GB
GW
Overseen ByGAINES W HAMMOND, MD
Age: 18+
Sex: Male
Trial Phase: Academic
Sponsor: Blue Halo Biomedical, LLC
Must be taking: Alpha-blockers, 5-alpha-reductase inhibitors
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

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.12345

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.35678

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.2591011

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.
See 3 more

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
See 5 more

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 OverviewThe 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
1Treatment groups
Experimental Treatment
Group I: Blue Halo Coil Catheter for Urinary RetentionExperimental Treatment1 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.

Find a Clinic Near You

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

References

The burden of prolonged indwelling catheter after acute urinary retention in Ikeja - Lagos, Nigeria. [2018]
Urinary catheters: history, current status, adverse events and research agenda. [2022]
Complications of urinary tract infections associated with devices used for long-term bladder management. [2019]
A simple method for insertion of an intraprostatic coil. [2019]
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]
The incidence of acute urinary retention secondary to BPH is increasing among California men. [2013]
Management of acute urinary retention: a worldwide survey of 6074 men with benign prostatic hyperplasia. [2021]
Acute urinary retention: which catheter? [2018]
A new self-retaining intraurethral device. An alternative to an indwelling catheter in patients with urinary retention due to infravesical obstruction. [2019]
11.United Statespubmed.ncbi.nlm.nih.gov
Self-retaining intraurethral stent: an alternative to long-term indwelling catheters or surgery in the treatment of prostatism. [2008]