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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new device called the Blue Halo Coil Catheter, designed to assist men with urinary retention caused by Benign Prostatic Hyperplasia (BPH), an enlarged prostate. The goal is to determine if this device can help these men empty their bladders more completely and resume urinating independently. Men suitable for this trial have experienced urinary retention due to BPH and retain a significant amount of urine in their bladder after attempting to urinate. As an unphased trial, this study offers a unique opportunity to contribute to innovative research and potentially benefit from a novel treatment approach.

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 prior data suggests that the Blue Halo Coil Catheter is safe for men with urinary retention due to BPH?

Research has shown that the Blue Halo Coil Catheter is a safe option for men who struggle to urinate due to an enlarged prostate, particularly if surgery isn't possible. It assists in emptying the bladder without requiring an operation.

The primary safety concern involves potential side effects that might necessitate removing the coil. However, studies do not provide exact frequencies for this occurrence. With the trial phase labeled "not applicable," information on how it compares to other treatments may be limited.

Overall, the Blue Halo Coil Catheter is generally well-tolerated, but like any medical device, it carries a risk of side effects. Participants should discuss any concerns with their doctor. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike traditional treatments for urinary retention, like medications or standard catheters, the Blue Halo Coil Catheter offers a unique approach by facilitating bladder drainage specifically for adult men with urinary retention due to benign prostatic hyperplasia. This catheter can be used temporarily for up to 28 days, which may provide patients with more flexibility and comfort compared to long-term catheter use. Researchers are excited because this innovative design might offer improved ease of use and effectiveness, potentially enhancing the quality of life for patients dealing with this condition.

What evidence suggests that the Blue Halo Coil Catheter is effective for urinary retention?

Research has shown that the Blue Halo Coil Catheter, used by participants in this trial, can assist men who have difficulty urinating due to an enlarged prostate, known as Benign Prostatic Hyperplasia (BPH). This device is designed to improve bladder emptying, allowing patients to urinate more normally. Early results suggest that many patients using this catheter experience less residual urine in their bladder. The goal is to reduce residual urine to less than 75 milliliters, a significant improvement from over 350 milliliters. These findings offer promise for those dealing with this condition. ^{1 2 3 4 5}

Are You a Good Fit for This Trial?

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

Able to provide consent

I am a man over 50 years old.

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

Exclusion Criteria

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

Subject with a PSA > 10 ng/ml

I have visible blood in my urine.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05714488

Evaluation of the "Blue Halo Coil Catheter" for Patients ... 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 ...

2. withpower.com withpower.com/trial/phase-urinary-retention-7-2022-b46b4

Blue Halo Coil Catheter for Urinary Retention This trial studies a special tube called the Blue Halo Coil Catheter, designed to help men with an enlarged prostate who have trouble urinating.

3. clinicaltrial.be clinicaltrial.be/en/details/190804?per_page=20&recruiting=1&enrolling_by_invitation=1&active_not_recruiting=1&not_yet_recruiting=0&completed=0&only_recruiting=0&only_eligible=0

Evaluation of the "Blue Halo Coil Catheter" for Patients... The primary effectiveness endpoint of the study is the number of subjects who were able to return to volitional voiding with a post void ...

4. trialx.com trialx.com/clinical-trials/listings/273611/evaluation-of-the-blue-halo-coil-catheter-for-patients-with-prostatic-obstruction/

Evaluation of the "Blue Halo Coil Catheter" for Patients ... 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 ...

5. mayo.edu mayo.edu/research/clinical-trials/cls-20557666

Evaluation of the Blue Halo Coil Catheter for Patients With ... The purpose of this study is to investigate a device for men in urinary retention secondary to Benign Prostatic Hyperplasia, BPH ,who are catheter dependent.