single arm study for Urinary Retention

Florida Urology Partners, Riverview, FL
Urinary Retentionblue halo coil catheter - Device
What conditions do you have?

Study Summary

This trial will study a device to help men with BPH urinary retention return to volitional voiding and lower their post-void residual.

Treatment Effectiveness

Phase-Based Effectiveness

1 of 3

Study Objectives

1 Primary · 4 Secondary · Reporting Duration: 56 days

28 days
Primary safety endpoint
Quality of Life Measurement
Secondary Safety Endpoint 1
Secondary Safety Endpoint 2
Secondary Safety Endpoint 3
The change in Post Void Residual from baseline to day 28 will be measured and reported
56 days
Bacterial Infection Monitoring
Trends in Renal Function
Urinary Bother Inventory

Trial Safety

Awards & Highlights

No Placebo Group
All patients enrolled in this trial will receive the new treatment.

Trial Design

1 Treatment Group

single arm study
1 of 1

Experimental Treatment

95 Total Participants · 1 Treatment Group

Primary Treatment: single arm study · No Placebo Group · N/A

single arm study
Experimental Group · 1 Intervention: blue halo coil catheter · Intervention Types: Device

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 56 days

Who is running the clinical trial?

Blue Halo Biomedical, LLCLead Sponsor

Eligibility Criteria

Age 18+ · Male Participants · 2 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have difficulty urinating due to an enlarged prostate that is larger than 50cc or has a prostatic urethral length of more than 5cm.
You can still participate if you are taking alpha-blocking or 5-alpha-reductase inhibitor drugs.

Frequently Asked Questions

Are any new participants being accepted into this experiment?

"Affirmative. provides evidence that this research is actively recruiting, commencing on August 1st 2022 and last amended on January 26th 2023. It requires 95 individuals to enrol from 3 distinct locations." - Anonymous Online Contributor

Unverified Answer

What is the cap on participants for this clinical experiment?

"Affirmative. According to, this medical experiment was first advertised on August 1st 2022 and is currently recruiting participants. 95 patients need to be enrolled from 3 separate locations." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.