RecruitingNot ApplicableNCT06769997

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

The Optizum Study: A Randomized, Blinded Single Center Study Evaluating the Optilume BPH Catheter System and the Rezum Water Vapor Therapy for the Treatment of Benign Prostatic Hyperplasia

Sponsor

Centre hospitalier de l'Université de Montréal (CHUM)

Enrollment

100 participants

Start Date

May 9, 2025

Study Type

INTERVENTIONAL

Conditions

Lower Urinary Track Symptoms Benign Prostatic Hyperplasia (BPH)

Summary

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).

Eligibility

Sex: MALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a medical device called Optilume® BPH Catheter System and a medical device called Rezum Water Vapor Therapy for people with benign prostatic hyperplasia (bph) and lower urinary track symptoms. The study is currently recruiting participants at 1 location.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEOptilume® BPH Catheter System

The technology is based on a device/drug combination consisting of two catheters: the Optilume BPH Prostatic Pre-dilation Catheter which is a non-drug coated catheter used to start commissurotomy between the lateral lobes of the prostate and the Optilume BPH Prostatic Dilatation DCB Catheter which is a drug coated catheter used to complete the commissurotomy and transfers drug (paclitaxel) to the pre-dilated prostatic urethra and anterior commissure. Hence, the device applies a mechanical dilatation to open prostatic urethral lumen to increase urine flow, followed by the transfer of paclitaxel drug to inhibit cell proliferation and maintain this dilatation.

DEVICERezum Water Vapor Therapy

The Rezum system is minimally invasive therapy for LUTS secondary to BPH. The system injects water vapor at 103°C generated by radiofrequency to create thermal energy via a transurethral approach. The vapor disperses through the tissue interstices within the treatment zone (transition zone). The injection of vapor last for approximatively 9 seconds and the number of injections depends on the prostate volume and length of the prostatic urethra.