Comparing Optilume catheter and Rezum water-vapor therapy for enlarged prostate (BPH)

The Optizum Study: A Randomized, Blinded Single Center Study Evaluating the Optilume BPH Catheter System and the Rezum Water Vapor Therapy for the Treatment of Benign Prostatic Hyperplasia

This compares Optilume catheter and Rezum water-vapor therapy to see which better eases lower urinary tract symptoms in men with enlarged prostates (BPH) sized 30–100 g.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 100 (estimated)
• Ages: 18 Years and up
• Sex: Male
• Sponsor: Centre hospitalier de l'Université de Montréal (CHUM) (other)
• Drugs / interventions: chemotherapy
• Locations: 1 site (Montreal, Quebec)
• Trial ID: NCT06769997 on ClinicalTrials.gov

What this trial studies

This trial at CHUM compares two minimally invasive treatments for benign prostatic hyperplasia: the Optilume BPH Catheter System, a drug-coated balloon dilation device, and the Rezum water vapor therapy, which uses steam to ablate prostate tissue. Eligible men with symptomatic BPH and prostate volumes between 30 and 100 g will receive one of the treatments and be followed for symptom scores, urinary flow, post-void residual, and safety outcomes. Key exclusions include prior prostate surgeries or minimally invasive prostate procedures, active urinary infection, suspected malignancy, significant bladder dysfunction, or chronic urinary retention. The goal is to provide direct comparative data on symptom relief, recovery, and adverse events to help guide treatment choice.

Who should consider this trial

Good fit: Men with bothersome lower urinary tract symptoms from BPH, prostate size 30–100 g, no prior prostate surgeries or minimally invasive prostate procedures, no active urinary infection, and ability to attend follow-up at CHUM are ideal candidates.

Not a fit: Men with very large prostates (>100 g), prior prostate interventions or surgery, active bladder or prostate cancer, significant bladder dysfunction (neurogenic bladder, strictures, bladder neck contracture), or chronic urinary retention are unlikely to benefit from these treatments.

Why it matters

Potential benefit: If successful, one or both treatments could offer effective symptom relief with shorter recovery and fewer side effects than more invasive prostate surgery.

How similar studies have performed: Rezum has multiple published studies showing durable symptom improvement, while Optilume received FDA approval in 2023 and has encouraging early data but less long-term evidence.

Eligibility criteria

Inclusion Criteria:

* Male subject with symptomatic BPH.
* Prostate size 30-100g.
* Able to complete the study protocol.

Exclusion Criteria:

* Unable or unwilling to sign the Informed Consent Form (ICF) and/or comply with follow-up requirements
* Presence of an artificial urinary sphincter or stent(s) in the urethra or prostate
* Any prior minimally invasive intervention (e.g., TUNA, Balloon, Microwave, Rezūm, UroLift) or surgical intervention of the prostate
* Confirmed or suspected malignancy of prostate or bladder
* Active urinary tract infection (UTI) confirmed by culture
* History of overt urinary incontinence requiring use of pads NOTE: Pad usage for post-micturition dribble is acceptable
* Presence of confounding diagnoses impacting lower urinary tract symptoms or bladder function (e.g., urethral strictures, bladder neck contracture, neurogenic bladder, detrusor instability, bladder stones, etc.)
* History of chronic urinary retention (e.g., PVR ≥300mL on two separate occasions, or catheter dependent drainage)
* Anatomy (e.g., presence of false passage or size of meatus) is not suitable for treatment with the Optilume BPH Catheter System
* Significant obstruction from median lobe (investigator opinion)
* Disease or other health condition that is not suitable for this study

Where this trial is running

Montreal, Quebec

• Centre Hospitalier de l'université de Montréal (CHUM) — Montreal, Quebec, Canada (RECRUITING)

Study contacts

• Principal investigator: Naeem Bhojani, MD — Centre hospitalier de l'Université de Montréal (CHUM)
• Study coordinator: Naeem Bhojani, MD

Conditions: Benign Prostatic Hyperplasia, Lower Urinary Track Symptoms, BPH, LUTS, Optilume, Rezum