Issues in outcomes research: an overview of randomization techniques for clinical trials.
Minsoo Kang, Brian G Ragan, Jae-Hyeon Park
https://pubmed.ncbi.nlm.nih.gov/18345348/Actively Recruiting
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
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 lUniversit de Montral.
CONDITIONS
Evaluation of the Optilume BPH Catheter System and the Rezum Water Vapor Therapy in Treating Benign Prostatic Hyperplasia
N
Naeem Bhojani, MD
A
Abbas Guennoun, MSc
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Centre hospitalier de l'Université de Montréal (CHUM)
Lead Sponsor
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Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
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)
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
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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