Optilume Catheter for Enlarged Prostate

(PEAK Trial)

Recruiting at 5 trial locations

Overseen By Brandon Shuler

Age: 18+

Sex: Male

Trial Phase: Academic

Sponsor: Urotronic Inc.

Disqualifiers: Prostate malignancy, UTI, Neurogenic bladder, Incontinence, Diabetes, others

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

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 16

Duration: 1 day

92 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to ensure the Optilume BPH Catheter System is safe and effective for treating urinary issues caused by an enlarged prostate (benign prostatic hyperplasia or BPH). The catheter is designed to improve symptoms such as weak urine flow or frequent urination. Men experiencing urinary issues due to BPH, including difficulty starting urination or a weak stream, might be suitable candidates. Participants should not have undergone prior prostate surgeries or interventions. As an unphased trial, this study provides participants the opportunity to contribute to the understanding of a new treatment option for BPH.

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. Please consult with the trial coordinators for more details.

What prior data suggests that the Optilume BPH Catheter System is safe for treating an enlarged prostate?

Research has shown that the Optilume BPH Catheter System safely treats an enlarged prostate. Studies have found that it significantly improves symptoms and quality of life for patients. Long-term follow-ups confirm its safety and effectiveness.

The possible side effects of using the Optilume BPH Catheter System generally resemble those of standard procedures involving a cystoscope (a tool used to look inside the bladder). These risks are well known and manageable. Overall, current data considers the treatment well-tolerated. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The Optilume BPH Catheter System is unique because it offers a novel approach to treating an enlarged prostate, or benign prostatic hyperplasia (BPH). Unlike traditional treatments like medications, which often involve daily pills, or invasive procedures like surgery, the Optilume catheter is a minimally invasive device that combines balloon dilation and drug delivery directly to the prostate. This method allows for targeted treatment, potentially reducing side effects and recovery time. Researchers are excited about this treatment because it promises to improve urinary flow and relieve BPH symptoms more efficiently, making life easier for patients without the downtime associated with surgery.

What evidence suggests that the Optilume BPH Catheter System is effective for an enlarged prostate?

Research shows that the Optilume BPH Catheter System, which trial participants will receive, effectively treats urinary problems caused by an enlarged prostate, known as Benign Prostatic Hyperplasia (BPH). Studies have found that patients experienced significant symptom relief and improved function for up to four years after treatment. The treatment also improved urine flow, helping to relieve blockages. Importantly, the Optilume BPH treatment maintained erectile function while improving urinary issues. Overall, evidence supports strong and lasting benefits for those with BPH. ^{1 2 3 5 6}

Who Is on the Research Team?

Steven Kaplan, MD, FACS

Principal Investigator

Professor of Urology

Are You a Good Fit for This Trial?

This trial is for men experiencing symptoms of an enlarged prostate, also known as Benign Prostatic Hyperplasia (BPH). Specific eligibility criteria are not provided, but typically participants should be adults with a diagnosis of BPH who meet certain health standards.

Inclusion Criteria

Willing to provide informed consent and comply with protocol required follow-up

Peak urinary flow rate (Qmax) 5-15 mL/sec with minimum voided volume of 125 mL

Able to be treated with the Optilume BPH Catheter System in accordance with the Instructions for Use

Exclusion Criteria

Presence of an artificial urinary sphincter, penile prosthesis, or stent(s) in the urethra or prostate

Obstructive median lobe in the opinion of the investigator

Unwilling to abstain from sexual intercourse or use a condom for 30 days post-procedure and utilize a highly effective contraceptive for at least 12 months post-procedure

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the Optilume BPH Catheter System treatment

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 months

Multiple visits (in-person and virtual) over 12 months

Semen Sub-Study Follow-up

Participants in the semen sub-study are monitored for changes in sperm concentration

3 months

Follow-up visits at 3 months

What Are the Treatments Tested in This Trial?

Interventions

• Optilume® BPH Catheter System

Trial Overview The Optilume® BPH Catheter System is being tested in this study. The system is designed to treat urinary problems caused by an enlarged prostate. This post-market study aims to confirm its safety and effectiveness after it has been approved for use.

How Is the Trial Designed?

Group I: Study Arm Experimental Treatment 1 Intervention

Optilume BPH Catheter System

Optilume® BPH Catheter System is already approved in United States, Canada for the following indications:

Approved in United States as Optilume BPH Catheter System for:

• Treatment of obstructive urinary symptoms associated with Benign Prostatic Hyperplasia (BPH) in men ≥ 50 years of age

Approved in Canada as Optilume BPH Catheter System for:

• Treatment of obstructive urinary symptoms associated with Benign Prostatic Hyperplasia (BPH) in men ≥ 50 years of age

Who Is Running the Clinical Trial?

Urotronic Inc.

Lead Sponsor

Trials

10

Recruited

1,400+

Published Research Related to This Trial

The Optilume BPH Catheter System is a minimally invasive treatment for benign prostatic hyperplasia (BPH) that combines balloon dilation with localized delivery of paclitaxel, which helps maintain long-term effectiveness.

This system can be used in an office setting without the need for general anesthesia, and early data suggest it leads to positive functional and sexual outcomes for patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

How I Do It: Optilume BPH catheter system. Elterman, DS., Gao, B., Zorn, KC., et al.[2023]

The Urolume self-expanding flexible endourethral stent was found to be effective in improving symptoms and urinary flow rates in patients with bladder outlet obstruction due to benign prostatic hyperplasia (BPH), with significant improvements noted over a 5-year follow-up period.

Despite a high failure rate attributed to selection and deployment challenges, the Urolume stent was confirmed to be a safe device, with most patients experiencing sustained symptom relief and good quality of life after the first year.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-term clinical results and quality of life after insertion of a self-expanding flexible endourethral prosthesis. Anjum, MI., Chari, R., Shetty, A., et al.[2019]

The Optilume® BPH Catheter System demonstrated significant efficacy in treating lower urinary tract symptoms (LUTS) related to benign prostatic hyperplasia (BPH), with 81% of subjects showing a ≥40% improvement in their International Prostate Symptom Score (IPSS) at both 3 months and 1 year after treatment.

The treatment was safe, with improvements in urinary flow rates and quality of life scores, and the results suggest that this minimally invasive approach could be a promising option for patients suffering from LUTS due to BPH.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

One-year outcomes after treatment with a drug-coated balloon catheter system for lower urinary tract symptoms related to benign prostatic hyperplasia. Kaplan, SA., Pichardo, M., Rijo, E., et al.[2022]

The Optilume BPH Catheter System significantly improved lower urinary tract symptoms in men with benign prostatic hyperplasia, showing a reduction in the International Prostate Symptom Score by 11.5 points at 1 year, compared to 8.0 points in the sham group.

Patients treated with Optilume BPH experienced a remarkable 125% increase in urinary flow rate, while the treatment was well tolerated and preserved sexual function, making it a promising minimally invasive option.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The PINNACLE Study: A Double-blind, Randomized, Sham-controlled Study Evaluating the Optilume BPH Catheter System for the Treatment of Lower Urinary Tract Symptoms Secondary to Benign Prostatic Hyperplasia. Kaplan, SA., Moss, J., Freedman, S., et al.[2023]

The Optilume BPH Catheter System significantly improved lower urinary tract symptoms (LUTS) in 80 subjects over 2 years, with IPSS scores dropping from 22.3 to 8.2, indicating effective symptom relief.

Functional improvements were also notable, with peak urinary flow rate (Qmax) increasing from 10.9 mL/s to 17.2 mL/s, and post-void residual urine volume (PVR) decreasing from 63.1 mL to 45.0 mL, while treatment-related adverse events were mostly minor and none occurred after the first year.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Durable benefit after treatment of obstructive benign prostatic hyperplasia with a novel drug-device combination product: 2-year outcomes from the EVEREST-I study. Pichardo, M., Rijo, E., Espino, G., et al.[2023]

A review of 2567 reports on various BPH treatment devices showed that over 99% of patients experienced no complications from device malfunctions, indicating a high level of safety across the modalities studied.

The use of morcellators during HoLEP was associated with the highest rate of serious complications, suggesting that urologists should be cautious and choose devices they are most familiar with to minimize risks.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Device Malfunctions and Complications Associated with Benign Prostatic Hyperplasia Surgery: Review of the Manufacturer and User Facility Device Experience Database. Patel, NH., Uppaluri, N., Iorga, M., et al.[2021]

The Optilume™ paclitaxel-coated balloon treatment for recurrent bulbar urethral strictures showed no serious adverse events within 90 days, indicating a strong safety profile for this intervention.

At the 12-month follow-up, 70% of patients achieved anatomic success, suggesting promising preliminary efficacy for this treatment, warranting further long-term studies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A drug-coated balloon treatment for urethral stricture disease: Interim results from the ROBUST I study. Virasoro, R., DeLong, JM., Mann, RA., et al.[2020]

Citations

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

Two-year long-term follow-up of treatment with the ... - Nature In the PINNACLE study, participants treated with the Optilume BPH Catheter System demonstrated strong improvement in symptoms and function ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11534392/

Long-term outcomes after treatment with Optilume BPH Long-term followup through four years for subjects treated with the Optilume BPH Catheter System indicates durable outcomes in symptom improvement and ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11228686/

The Optilume BPH Catheter System for the treatment of ... Although the Optilume BPH treatment was significantly beneficial, the results may not be hypothesized toward all men experiencing LUTS ...

4. auajournals.org auajournals.org/doi/10.1097/JU.0000000000003568

The PINNACLE Study: A Double-blind, Randomized, Sham ... Treatment with Optilume BPH provides immediate and sustained improvements in obstructive symptoms and flow rate while preserving erectile and ...

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

SUMMARY OF SAFETY AND EFFECTIVENESS DATA (SSED) The Optilume BPH Catheter System is indicated for the treatment of obstructive urinary symptoms associated with Benign Prostatic Hyperplasia ( ...

6. 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.