Optilume vs Rezum for Enlarged Prostate
(OptiZum Trial)

Recruiting in Palo Alto (17 mi)

Overseen byNaeem Bhojani, MD

Age: 18+

Sex: Male

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

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

No Placebo Group

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).

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.

+8 more

Participant Groups

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.

2Treatment groups

Active Control

Group I: Optilume® BPH Catheter SystemActive Control1 Intervention

Group II: Rezum Water Vapor TherapyActive Control1 Intervention