What side effects are associated with this type of intervention?

Common treatments for urinary retention, particularly those aimed at reducing post-void residual, include catheterization, medications like alpha-blockers (e.g., tamsulosin, alfuzosin), and surgical interventions such as midurethral sling procedures. Side effects of catheterization can include urinary tract infections and discomfort. Alpha-blockers may cause dizziness, headache, and orthostatic hypotension. Surgical interventions can lead to complications such as urinary tract infections, acute urinary retention, and voiding dysfunction.

What prior FDA approvals exist?

FDA-approved treatments for urinary retention, particularly in the context of benign prostatic hyperplasia (BPH), include alpha-1-adrenergic antagonists such as doxazosin and terazosin, and 5-alpha reductase inhibitors like finasteride. These medications help reduce post-void residual (PVR) by relaxing the muscles of the prostate and bladder neck, facilitating easier urination. While the Blue Halo Coil Catheter is a device under investigation for similar purposes, these medications represent the primary pharmacologic options currently approved for managing urinary retention associated with BPH.

What other types of research exist?

Promising novel alternatives for urinary retention patients include: 1) Intradetrusor botulinum toxin A, which can help by reducing bladder overactivity. 2) Sacral neuromodulation, which modulates nerve activity to improve bladder function. Both therapies are considered for patients who have not responded to other treatments.

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Device

Blue Halo Coil Catheter for Urinary Retention (BlueHaloCoil Trial)

N/A

Recruiting

Research Sponsored by Blue Halo Biomedical, LLC

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 56 days

Awards & highlights

No Placebo-Only Group

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Potential side effects may include discomfort during catheter use, urinary tract infections from repeated catheterization, possible injury to the urethra or bladder, and irritation leading to increased urgency or frequency of urination.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 56 days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~56 days

This trial's timeline: 3 weeks for screening, Varies for treatment, and 56 days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

The change in Post Void Residual from baseline to day 28 will be measured and reported

Secondary study objectives

Primary safety endpoint adverse event and device removal

Secondary Safety Endpoint 1, incidence of device encrustation at removal

Secondary Safety Endpoint 2,urinary obstruction due to device migration

+1 more

Other study objectives

Bacterial Infection Monitoring

Quality of Life Measurement, no scale to report

Trends in Renal Function

+1 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

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.

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Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for urinary retention include catheterization, alpha-1-adrenergic antagonists, and surgical interventions. Catheterization, either intermittent or indwelling, mechanically drains the bladder, providing immediate relief from retention. Alpha-1-adrenergic antagonists, such as tamsulosin, work by relaxing the smooth muscle in the bladder neck and prostate, reducing resistance to urine flow and facilitating voiding. Surgical interventions, like transurethral resection of the prostate (TURP), remove or reduce prostate tissue obstructing the urethra, significantly lowering the risk of acute urinary retention. These treatments are crucial as they address the underlying causes of retention, improve bladder emptying, and reduce complications associated with high PVR, enhancing the quality of life for patients.

Urodynamics of the female lower urinary tract.The role of perioperative medications in urinary retention following midurethral sling.Repeat post-op voiding trials: an inconvenient correlate with success.