Actively Recruiting
Evaluation of the Optilume BPH Catheter System and the Rezum Water Vapor Therapy in Treating Benign Prostatic Hyperplasia
Led by Centre hospitalier de l'Université de Montréal (CHUM) · Updated on 2025-07-17
100
Participants Needed
1
Research Sites
86 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Evaluation of the Optilume BPH Catheter System and the Rezum Water Vapor Therapy in Treating Benign Prostatic Hyperplasia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male subject with symptomatic BPH.
- Prostate size 30-100g.
- Able to complete the study protocol.
You will not qualify if you...
- 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, Rez6bm, 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 (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 64300mL on two separate occasions, or catheter dependent drainage)
- Anatomy (e.g., presence of false passage or size of meatus) 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
AI-Screening
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Trial Site Locations
Total: 1 location
1
Centre Hospitalier de l'université de Montréal (CHUM)
Montreal, Quebec, Canada, H2X 0A9
Actively Recruiting
Research Team
N
Naeem Bhojani, MD
CONTACT
A
Abbas Guennoun, MSc
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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