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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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
• Email: naeem.bhojani@gmail.com
• Phone: 514-890-8000

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.