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Evaluation of the Optilume BPH Catheter System and the Rezum Water Vapor Therapy in Treating Benign Prostatic Hyperplasia

RecruitingNAAges 18 Years - anyMaleCentre hospitalier de l'Université de Montréal (C…
NCT06769997 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 managem

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📋 Eligibility rules (as published)
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
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What it tests

  • Optilume® BPH Catheter System
  • Rezum Water Vapor Therapy
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Where

1 site
Centre Hospitalier de l'université de Montréal (CHUM)
Montreal, Canada
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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