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

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: Male
Minimum Age: 18
Healthy Volunteers: f
View:

• Male subject with symptomatic BPH.

• Prostate size 30-100g.

• Able to complete the study protocol.

Locations
Other Locations
Canada
Centre Hospitalier de l'université de Montréal (CHUM)
RECRUITING
Montreal
Contact Information
Primary
Naeem Bhojani, MD
naeem.bhojani@gmail.com
514-890-8000
Backup
Abbas Guennoun, MSc
abbas.guennoun.chum@ssss.gouv.qc.ca
Time Frame
Start Date: 2025-05-09
Estimated Completion Date: 2027-01
Participants
Target number of participants: 100
Treatments
Active_comparator: Optilume® BPH Catheter System
Active_comparator: Rezum Water Vapor Therapy
Sponsors
Leads: Centre hospitalier de l'Université de Montréal (CHUM)

This content was sourced from clinicaltrials.gov