The international index of erectile function (IIEF): a multidimensional scale for assessment of erectile dysfunction.
R C Rosen, A Riley, G Wagner...
https://pubmed.ncbi.nlm.nih.gov/9187685Actively Recruiting
Phase Not Applicable
Age: 18Years +
MALE
ID06769997
The Optizum Study: Comparing Optilume BPH Catheter System and Rezum Water Vapor Therapy for Benign Prostatic Hyperplasia Treatment
Led by Centre hospitalier de l'Université de Montréal (CHUM) · Updated on 2025-07-17
100
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Lower urinary symptoms (LUTS) commonly affect older men and tend to worsen with age due to benign prostatic hyperplasia (BPH), which can cause bladder outlet obstruction and impact quality of life. This research aims to compare two innovative treatments, the Optilume BPH Catheter System and Rezum Water Vapor Therapy, in relieving symptoms and improving function in men with BPH. The study is a prospective, randomized, single-center clinical trial funded by Laborie (Urotronic) and led by the Centre hospitalier de l'Université de Montréal.
CONDITIONS
Brief Title
Evaluation of the Optilume BPH Catheter System and the Rezum Water Vapor Therapy in Treating Benign Prostatic Hyperplasia
Who Can Participate
Age: 18Years +
MALE
Eligibility Criteria
You may qualify if you...
- Male subject with symptomatic benign prostatic hyperplasia (BPH)
- Prostate size between 30 and 100 grams
- Able to complete the study protocol
You will not qualify if you...
- Unable or unwilling to sign the informed consent form or comply with follow-up
- Presence of artificial urinary sphincter or stents in urethra or prostate
- Prior minimally invasive or surgical prostate interventions (e.g., TUNA, Balloon, Microwave, Rezum, UroLift)
- Confirmed or suspected prostate or bladder cancer
- Active urinary tract infection confirmed by culture
- History of overt urinary incontinence requiring pads (except post-micturition dribble)
- Conditions impacting lower urinary tract symptoms or bladder function (e.g., strictures, bladder neck contracture, neurogenic bladder, bladder stones)
- History of chronic urinary retention or catheter-dependent drainage
- Anatomy unsuitable for treatment with Optilume BPH Catheter System
- Significant obstruction from median lobe (investigator opinion)
- Any disease or health condition making participation unsuitable
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Implementation
Duration - Procedure day
Participants undergo treatment with either the Optilume® BPH Catheter System or Rezum Water Vapor Therapy to relieve symptoms of benign prostatic hyperplasia.
1 procedure visit (in-person)
Post-operative Follow-up
Duration - 1 year
Participants are monitored and evaluated through multiple follow-up visits to assess symptom relief, functional improvement, and safety after the procedure.
5 visits (in-person) at 1 week, 1 month, 3 months, 6 months, and 12 months post-procedure
Trial Site Locations
Total: 1 location
1
Centre Hospitalier de l'université de Montréal (CHUM)
Montreal, Quebec, Canada, H2X 0A9
Actively Recruiting
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Research Team
N
Naeem Bhojani, MD
A
Abbas Guennoun, MSc
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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Kevin T McVary, Tyson Rogers, Claus G Roehrborn
https://pubmed.ncbi.nlm.nih.gov/30677455Minimally Invasive Prostate Convective Water Vapor Energy Ablation: A Multicenter, Randomized, Controlled Study for the Treatment of Lower Urinary Tract Symptoms Secondary to Benign Prostatic Hyperplasia.
Kevin T McVary, Steven N Gange, Marc C Gittelman...
https://pubmed.ncbi.nlm.nih.gov/26614889The PINNACLE Study: A Double-blind, Randomized, Sham-controlled Study Evaluating the Optilume BPH Catheter System for the Treatment of Lower Urinary Tract Symptoms Secondary to Benign Prostatic Hyperplasia.
Steven A Kaplan, Jared Moss, Sheldon Freedman...
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José Santos Dias
https://pubmed.ncbi.nlm.nih.gov/23244722The development of human benign prostatic hyperplasia with age.
S J Berry, D S Coffey, P C Walsh...
https://pubmed.ncbi.nlm.nih.gov/6206240