Evaluation of the Optilume BPH Catheter System and the Rezum Water Vapor Therapy in Treating Benign Prostatic Hyperplasia
Recruiting
N/A
Interventional Study
Benign Prostatic Hyperplasia (BPH)
Lower Urinary Track Symptoms
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
At a Glance
- Age
- 18 and older
- Sex
- Male
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 100 (estimated)
- Sponsor
- Centre hospitalier de l'Université de Montréal (CHUM) · Other
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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 prost…
Trial Locations
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Eligibility Criteria
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 ste…
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