Optilume vs Rezum for Enlarged Prostate

(OptiZum Trial)

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

Trial Summary

What is the purpose of this trial?

Lower urinary symptoms (LUTS) affect older men and their frequency and severity increase with age. According to Berry et al., the histological diagnosis of benign prostatic hyperplasia (BPH) increases from 25% in the group age between 40 to 49 years to 80% in the group age between 70 to 79 years (1). However, this hyperplasia can lead to a bladder outlet obstruction (BOO) secondary to benign prostatic enlargement (BPE), causing storage and voiding symptoms, associated with a considerable impairment of the quality of life (2). Surgical therapy of BPH has continuously evolved in recent years. The current gold standard for the endoscopic treatment of BPH is the transurethral resection of the prostate (TURP). Other innovative techniques were developed including Urolift, transurethral laser enucleation (holmium, thulium) and Aquablation therapy. One of the latest technologies for the management of BPH are Optilume BPH Catheter System (Optilume®, Urotronic Inc, Minneapolis, USA) and Rezum Water Vapor Therapy (Rezum System, Bostocn Scientific, Marlborough, MA). The purpose of the present study is to compare between patient experience, symptom relief and functional improvement when using the Optilume BPH Catheter System (Optilume®, Urotronic Inc, Minneapolis, USA) and Rezum Water Vapor Therapy (Rezum System, Boston Scientific, Marlborough, MA).

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.

What data supports the effectiveness of the Optilume BPH Catheter System and Rezum Water Vapor Therapy for treating an enlarged prostate?

Research shows that the Optilume BPH Catheter System, which combines balloon dilation with a drug to keep the prostate open, has favorable outcomes for urinary symptoms and sexual function. Additionally, studies comparing Rezum Water Vapor Therapy to other treatments indicate it is effective in reducing symptoms of an enlarged prostate. ^{1 2 3 4 5}

How is the Optilume BPH Catheter System different from other treatments for enlarged prostate?

The Optilume BPH Catheter System is unique because it combines a drug and device approach to treat enlarged prostate, offering a novel method compared to traditional surgical or thermal therapies. It aims to provide durable relief from urinary symptoms by using a catheter system that delivers treatment directly to the prostate. ^{1 3 4 6 7}

Research Team

Naeem Bhojani, MD

Principal Investigator

Centre hospitalier de l'Université de Montréal (CHUM)

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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

Group II: Rezum Water Vapor Therapy 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+

Findings from Research

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]

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]

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]

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]

References

1. Germany 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. [2023]

2. United States 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. [2023]

3. Canada 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. [2022]

4. Netherlands 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. [2022]

5. Canada pubmed.ncbi.nlm.nih.gov

How I Do It: Optilume BPH catheter system. [2023]

6. United States pubmed.ncbi.nlm.nih.gov

Emphysematous sloughed floating ball after prostate water vaporization Rezum: A case report. [2023]

7. United States pubmed.ncbi.nlm.nih.gov

What's New in Rezum: a Transurethral Water Vapour Therapy for BPH. [2020]