Optilume vs Rezum for Enlarged Prostate

(OptiZum Trial)

Recruiting at 1 trial location

Overseen By Abbas Guennoun, Msc candidate

Age: 18+

Sex: Male

Trial Phase: Academic

Sponsor: Centre hospitalier de l'Université de Montréal (CHUM)

Disqualifiers: Prostate malignancy, UTI, Incontinence, others

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

Compensation: Varies

Number of Visits: 7

Duration: 1 day

100 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests two treatments, Optilume (a catheter system) and Rezum (water vapor therapy), to determine which better alleviates symptoms of an enlarged prostate, such as difficulty urinating. Both treatments are newer options designed to improve life quality by easing these symptoms. Men with noticeable symptoms from an enlarged prostate and a prostate size between 30-100 grams may be suitable candidates for this trial. The goal is to identify which treatment provides better symptom relief and improves daily function. As an unphased trial, this study offers a unique opportunity to explore innovative treatments that could significantly enhance quality of life.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. Please consult with the study team for guidance.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that both the Optilume BPH Catheter System and Rezum Water Vapor Therapy are safe for treating symptoms of an enlarged prostate.

Studies have found the Optilume BPH Catheter System to be safe and effective, improving symptoms and quality of life. Possible side effects resemble those from standard procedures that use a thin tube with a camera to examine the bladder.

Rezum Water Vapor Therapy is also safe and minimally invasive. It effectively reduces prostate symptoms while preserving sexual function. Common side effects include painful or frequent urination, but these are usually manageable.

Both treatments have undergone testing with positive results, making them promising options for managing symptoms of an enlarged prostate. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about these treatments for an enlarged prostate because they offer innovative approaches compared to traditional methods like medication or surgery. The Optilume BPH Catheter System stands out by using a unique balloon dilation technique combined with a drug-coated balloon that delivers medication directly to the prostate tissue, potentially reducing symptoms more effectively and with fewer side effects. On the other hand, Rezum Water Vapor Therapy uses the natural energy stored in water to shrink excess prostate tissue, which can be less invasive and offer quicker recovery times than surgical options. Both treatments aim to improve patient quality of life by providing relief with minimal discomfort and downtime.

What evidence suggests that this trial's treatments could be effective for enlarged prostate?

This trial will compare the Optilume BPH Catheter System with Rezum Water Vapor Therapy for treating an enlarged prostate. Research has shown that the Optilume BPH Catheter System can greatly improve urinary symptoms and function in men with an enlarged prostate, with benefits lasting up to four years after treatment. Meanwhile, Rezum Water Vapor Therapy effectively reduces symptoms of benign prostatic hyperplasia (BPH), with studies indicating improvements in urinary flow and symptom reduction for up to five years. Both treatments in this trial aim to ease bladder blockage and enhance quality of life without causing major side effects. ^{1 2 3 5 6}

Who Is on the Research Team?

Naeem Bhojani, MD

Principal Investigator

Centre hospitalier de l'Université de Montréal (CHUM)

Are You a Good Fit for This Trial?

This trial is for older men with benign prostatic hyperplasia (BPH), which causes urinary symptoms due to an enlarged prostate. Participants should have a diagnosis of BPH and experience related lower urinary tract symptoms.

Inclusion Criteria

My prostate size is between 30 to 100 grams.

Able to complete the study protocol

I am a man with symptoms from an enlarged prostate.

Exclusion Criteria

Unable or unwilling to sign the Informed Consent Form (ICF) and/or comply with follow-up requirements

I have an artificial device in my urinary system.

I have had a procedure or surgery on my prostate.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

3 months

1 visit (in-person)

Treatment

Participants receive either the Optilume BPH Catheter System or Rezum Water Vapor Therapy

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 months

5 visits (in-person) at 1 week, 1 month, 3 months, 6 months, and 12 months

What Are the Treatments Tested in This Trial?

Interventions

• Optilume BPH Catheter System
• Rezum Water Vapor Therapy

Trial Overview The study compares two treatments for BPH: the Optilume BPH Catheter System and Rezum Water Vapor Therapy. It aims to evaluate patient experiences, symptom relief, and functional improvements with these technologies.

How Is the Trial Designed?

Group I: Rezum Water Vapor Therapy Active Control 1 Intervention

Group II: Optilume® BPH Catheter System Active Control 1 Intervention

Who Is Running the Clinical Trial?

Centre hospitalier de l'Université de Montréal (CHUM)

Lead Sponsor

Trials

389

Recruited

143,000+

Published Research Related to This Trial

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]

In a study comparing Rezūm™ and Urolift™ treatments for benign prostatic hyperplasia (BPH) in 48 patients, Rezūm™ showed a trend towards greater improvement in urinary symptoms (IPSS) and quality of life after 12 months, although the difference was not statistically significant.

Both treatments had low rates of serious adverse events and did not significantly affect sexual function, but Rezūm™ had a lower retreatment rate (8.3%) compared to Urolift™ (25%), suggesting it may be a more effective long-term option.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Head-to-head comparison of prostatic urethral lift and water vapor thermal therapy for the treatment of symptomatic benign prostatic hyperplasia: a real-life study. Baboudjian, M., Fourmarier, M., Gondran-Tellier, B., et al.[2022]

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 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]

Rezum showed greater improvement in lower urinary tract symptoms (LUTS) compared to UroLift at 24 and 36 months, with a statistically significant difference in symptom scores favoring Rezum.

UroLift was more effective in improving ejaculatory function, demonstrating significant reductions in ejaculatory dysfunction compared to Rezum, while both treatments had similar overall improvements in symptom bother over time.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prostatic urethral lift (UroLift) versus convective water vapor ablation (Rezum) for minimally invasive treatment of BPH: a comparison of improvements and durability in 3-year clinical outcomes. Elterman, D., Shepherd, S., Saadat, SH., et al.[2022]

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. 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 ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT06769997

Evaluation of the Optilume BPH Catheter System and ... The purpose of the present study is to compare between patient experience, symptom relief and functional improvement when using the Optilume BPH Catheter ...

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.