Optilume BPH Catheter for Enlarged Prostate

(APEX Trial)

Recruiting at 8 trial locations

Overseen By Brandon Shuler

Age: Any Age

Sex: Male

Trial Phase: Academic

Sponsor: Urotronic Inc.

Disqualifiers: Prostate malignancy, Bladder malignancy, UTI, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 12 months

500 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines the effectiveness of the Optilume™ BPH Catheter System for men with symptoms of benign prostatic hyperplasia (BPH), a condition where an enlarged prostate causes issues like frequent urination. The goal is to collect real-world data on the treatment's effectiveness. Men who have already used the Optilume BPH Catheter System as instructed are suitable candidates for this trial. However, those with implants or current infections may not qualify. As a Phase 4 trial, this study aims to understand how this FDA-approved treatment benefits a broader range of patients.

Do I have to stop taking my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that the Optilume™ BPH Catheter System is safe for treating symptomatic BPH?

Research has shown that the Optilume™ BPH Catheter System is generally safe for treating symptoms of an enlarged prostate, also known as BPH (Benign Prostatic Hyperplasia). Studies have found that its side effects resemble those of standard treatments for this condition. In one study, participants experienced positive results two years after treatment, indicating that the treatment is well-tolerated over time. While side effects can occur, they are similar to those of other common BPH procedures. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The OPtilume™ BPH Catheter System is unique because it combines balloon dilation with drug-coated technology to treat symptomatic benign prostatic hyperplasia (BPH). Unlike traditional treatments such as medications, which may take weeks to show effects, or surgical options that can be invasive, OPtilume™ delivers immediate physical relief by widening the urethra while also releasing a therapeutic agent that could minimize future tissue growth. This dual-action approach not only aims to provide quicker symptomatic relief but also potentially reduces the need for repeated treatments, making it an exciting development in BPH management.

What evidence suggests that the Optilume™ BPH Catheter System is effective for treating symptomatic BPH?

Research has shown that the Optilume™ BPH Catheter System can help men with symptoms of benign prostatic hyperplasia (BPH), or an enlarged prostate. This system improves urine flow and reduces symptoms. Studies have found that men using the Optilume system experience significant relief, with many reporting better control over their urinary issues. The treatment uses a thin tube called a catheter to open the urethra, the tube that carries urine out of the body. This reduces blockage caused by the enlarged prostate, making urination easier and less uncomfortable. Early results suggest that the system effectively relieves BPH symptoms in everyday life.

Are You a Good Fit for This Trial?

Inclusion Criteria

I have been treated with the Optilume BPH Catheter System as directed.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive treatment with the Optilume™ BPH Catheter System

12 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 months

Long-term follow-up

Participants are monitored for long-term outcomes and adverse events

Additional 12 months

What Are the Treatments Tested in This Trial?

Interventions

• Optilume™ BPH Catheter System

How Is the Trial Designed?

Group I: Study Arm Experimental Treatment 1 Intervention

This is the data collection study arm. There is no other arm in the study.

Who Is Running the Clinical Trial?

Urotronic Inc.

Lead Sponsor

Trials

10

Recruited

1,400+

Citations

1. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/pdf22/P220029B.pdf

SUMMARY OF SAFETY AND EFFECTIVENESS DATA (SSED) Potential adverse effects after treatment with the Optilume BPH Catheter System are similar to standard cystoscopic procedures and mechanical ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06312722

Safety and Effectiveness of the Optilume® BPH Catheter ... The goal of this clinical trial is to verify the continued safety and effectiveness for the Optilume BPH Catheter System. STUDY ENDPOINTS.

3. fda.gov fda.gov/medical-devices/recently-approved-devices/optilume-bph-catheter-system-p220029

Optilume BPH Catheter System – P220029 See the links below to the Summary of Safety and Effectiveness Data ... The Optilume BPH Catheter System includes two catheters: the Optilume BPH ...

4. laborie.com laborie.com/product/optilume-for-bph/

Optilume® BPH Catheter System for the treatment of BPH Safe. Safety profile in-line with existing BPH MISTs (1,2) ... Optilume® BPH Catheter System Data from the PINNACLE Trial Published in the September 2023 Journal ...

5. nature.com nature.com/articles/s41391-024-00833-z

Two-year long-term follow-up of treatment with the ... Participants treated with the Optilume BPH Catheter System demonstrated continued and durable results at 2 years, affirming tolerability, safety, and the ...