Comparing Optilume® BPH Catheter System with Rezum Water Vapor Therapy for benign prostatic hyperplasia (BPH)
Official title: Evaluation of the Optilume BPH Catheter System and the Rezum Water Vapor Therapy in Treating Benign Prostatic Hyperplasia
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
- 2 groups
- One site, in Montreal
- Recruiting
Interventions
- Medical device
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.
- Medical device
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.
Canadian Sites (1)
1 of 1 recruiting
- Recruiting
Centre Hospitalier de l'université de Montréal (CHUM)
Montreal, Quebec
Eligibility Criteria
See who this study is looking for14 criteria
The trial’s own eligibility text, word for word from the registry. Only the trial site can say who takes part.
Inclusion
- +Prostate size 30-100g.
- +Male subject with symptomatic BPH.
- +Able to complete the study protocolProtocolThe detailed plan a study must follow.Read more →.
Exclusion
- −Unable or unwilling to sign the Informed Consent FormInformed consentThe process of being told what taking part involves, then choosing freely.Read more → (ICF) and/or comply with follow-upFollow-upContinued check-ins after the treatment part is finished.Read more → 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 (investigatorPrincipal investigatorThe doctor or researcher responsible for running the study at a site.Read more → opinion)
- −Disease or other health condition that is not suitable for this study
In plain language
Assembled directly from this trial’s registry record. Every sentence traces to a field below — nothing here is generated or interpreted.
What this study is
This study is testing a treatment for a condition.
This study is not organised into the usual phase numbers — that is common for device, behavioural, and diagnostic research.
From the trial registry
Built from these fields:
- designModule.designInfo.primaryPurpose
- designModule.phases
Who receives what
There are 2 groups in this study.
Group A, the comparison group, receives Optilume® BPH Catheter System.
Registry label: A: Optilume® BPH Catheter System
Group B, the comparison group, receives Rezum Water Vapor Therapy.
Registry label: B: Rezum Water Vapor Therapy
From the trial registry
Built from these fields:
- armsInterventionsModule.armGroups[].label
- armsInterventionsModule.armGroups[].type
- armsInterventionsModule.armGroups[].interventionNames
How the study is run
Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.
One group of people involved — usually the participants — is not told which treatment is which.
From the trial registry
Built from these fields:
- designModule.designInfo.allocation
- designModule.designInfo.maskingInfo.masking
Is there a placebo?
This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.
One group receives an existing treatment, so the two can be compared.
From the trial registry
Built from these fields:
- armsInterventionsModule.armGroups[].type
- armsInterventionsModule.armGroups[].interventionNames
Who the study is looking for
The study lists a minimum age of 18 years, with no upper limit given.
The study lists male participants only.
The study does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
These are the criteria the study lists. Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part.
From the trial registry
Built from these fields:
- eligibilityModule.minimumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How big and how long
The study aims to enrol about 100 people.
The study is currently expected to finish around January 2027.
The main measurement is taken over: 3 days.
From the trial registry
Built from these fields:
- designModule.enrollmentInfo.count
- statusModule.completionDateStruct.date
- outcomesModule.primaryOutcomes[].timeFrame
What the study measures
The rate of patients without a catheter (catheter free) — measured over 3 days.
Frequency and severity of treatment related adverse eventsAdverse eventAny medical problem that happens during a study, whether or not the treatment caused it.Read more → — measured over Through study completion, an average of 2 years.
From the trial registry
Built from these fields:
- outcomesModule.primaryOutcomes[].measure
- outcomesModule.primaryOutcomes[].timeFrame
Source: NCT06769997 on ClinicalTrials.gov. The full registry text is further down this page — this summary never replaces it.
Not medical advice. What do these terms mean?
What is being tested — in plain terms
About Optilume® BPH Catheter SystemDevice
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.
From the trial registry — its own words, unedited.
What a device is here: A physical instrument, implant, app or piece of equipment being studied.
Read the full explanation → · in clinical review
About Rezum Water Vapor TherapyDevice
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.
From the trial registry — its own words, unedited.
What a device is here: A physical instrument, implant, app or piece of equipment being studied.
Read the full explanation → · in clinical review
Common questions
Answered from this trial’s registry record. Where the record doesn’t say, these answers say so rather than filling the gap.
Am I eligible for this trial?
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part. Concord cannot make that determination, and neither can any tool that has not examined you.
What the study lists: a minimum age of 18 years.
The full inclusionInclusion criteriaThe things you must have or be for a study to consider you.Read more → and exclusion criteriaExclusion criteriaThe things that would prevent someone from taking part.Read more → are published on this page, exactly as the study team wrote them.
The useful next step is to bring this trial to your doctor. Answering a few questions first gives them something concrete to review.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.eligibilityCriteria
Is there a placebo?
This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.
One group receives an existing treatment so the two can be compared.
From the trial registry
- armsInterventionsModule.armGroups[].type
Would I know which treatment I am getting?
One group of people involved — usually the participants — is not told which treatment is which.
Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.
From the trial registry
- designModule.designInfo.maskingInfo.masking
- designModule.designInfo.allocation
Who can join?
The study lists a minimum age of 18 years, with no upper limit given.
It lists male participants only.
It does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can confirm whether a particular person can take part.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How long would this take?
The study's main measurement is taken over: 3 days.
The study as a whole is currently expected to finish around 2027-01.
How long any one person takes part can differ from the study length. The study team can tell you what the schedule looks like in practice.
From the trial registry
- outcomesModule.primaryOutcomes[].timeFrame
- statusModule.completionDateStruct.date
How many people are taking part?
The study aims to enrol about 100 people.
From the trial registry
- designModule.enrollmentInfo.count
Where is this happening?
This study lists one location: Montreal, Quebec, Canada.
Sites can open and close during a study, so confirm with the team before travelling.
From the trial registry
- trial_locations
About 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).
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See if this trial could fit youThis page is for informational purposes only and does not constitute medical advice. Clinical trial eligibility can only be determined by the trial site after proper screening. Trial information is sourced from ClinicalTrials.gov and may not reflect the most current status. Always consult your healthcare provider before making decisions about clinical trial participation.