Recruiting

Optilume & Rezum

Sponsor:

Centre hospitalier de l'Université de Montréal (CHUM)

Code:

NCT06769997

Conditions

Benign Prostatic Hyperplasia (BPH)

Lower Urinary Track Symptoms

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Optilume® BPH Catheter System

Rezum Water Vapor Therapy

Study Details

Brief summary:

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).

Conditions

Benign Prostatic Hyperplasia (BPH)

Lower Urinary Track Symptoms

Study ID

NCT06769997

Start date

May 9, 2025

Status verified date

Jul, 2025

Completion date

Jan, 2027

Anticipated

Primary completion date

Jan, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

100 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Optilume® BPH Catheter System

active comparator: Rezum Water Vapor Therapy

Interventions

Optilume® BPH Catheter System

The technology is based on a device/drug combination consisting of two catheters: the Optilume BPH Prostatic Pre-dilation Catheter which is a non-drug coated catheter used to start commissurotomy between the lateral lobes of the prostate and the Optilume BPH Prostatic Dilatation DCB Catheter which is a drug coated catheter used to complete the commissurotomy and transfers drug (paclitaxel) to the pre-dilated prostatic urethra and anterior commissure. Hence, the device applies a mechanical dilatation to open prostatic urethral lumen to increase urine flow, followed by the transfer of paclitaxel drug to inhibit cell proliferation and maintain this dilatation.

Rezum Water Vapor Therapy

The Rezum system is minimally invasive therapy for LUTS secondary to BPH. The system injects water vapor at 103°C generated by radiofrequency to create thermal energy via a transurethral approach. The vapor disperses through the tissue interstices within the treatment zone (transition zone). The injection of vapor last for approximatively 9 seconds and the number of injections depends on the prostate volume and length of the prostatic urethra.

Primary outcome measure

  • The rate of patients without a catheter (catheter free) [ Time Frame: 3 days ]
  • Frequency and severity of treatment related adverse events [ Time Frame: Through study completion, an average of 2 years ]

Central Contacts and Locations

Central contacts

Naeem Bhojani, MD

514-890-8000naeem.bhojani@gmail.com

Abbas Guennoun, MSc

abbas.guennoun.chum@ssss.gouv.qc.ca

Locations

Centre Hospitalier de l'université de Montréal (CHUM)

Recruiting

Montreal, Quebec, Canada, H2X 0A9

Contacts

Naeem Bhojani, MD

514-890-8000naeem.bhojani@gmail.com

Abbas Guennoun, MSc candidate

abbas.guennoun.chum@ssss.gouv.qc.ca

Principal Investigator:

Naeem Bhojani, MD

More Information

Sponsor

Centre hospitalier de l'Université de Montréal (CHUM)

Last update posted

Jul 17, 2025

Last verified

Jul, 2025

Keywords

  • Benign Prostatic Hyperplasia
  • Lower Urinary Track Symptoms
  • BPH
  • LUTS
  • Optilume
  • Rezum

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Centre hospitalier de l'Université de Montréal (CHUM) on 2025-07-17.