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).
Male subject with symptomatic BPH.
Prostate size 30-100g.
Able to complete the study protocol.
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
Parallel
Optilume® BPH Catheter System
DeviceThe 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.
Rezum Water Vapor Therapy
DeviceThe 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.
The rate of patients without a catheter (catheter free)
The primary efficacy endpoint is defined as the rate of patients without a catheter (catheter free) 3 days after the procedure.
Frequency and severity of treatment related adverse events
The primary safety endpoint is defined as the frequency and severity of treatment related adverse events reported using the Clavien-Dindo severity grading system.
The change of the International Prostate Symptom Score (IPSS)
* The International Prostate Symptom Score (IPSS) change from baseline to 3, 6 and 12 months. * Score : 0-7 (Mild), 8 to 19 (Moderate), 20 to 35 (Severe)
International Prostate Symptom Score (IPSS) Quality of Life (QoL)
IPSS Quality of Life (QoL) change from baseline to 3, 6 and 12 months. Minimum value : 0 (Delighted) Maximum value : 6 (Terrible)
Maximum Flow Rate (Qmax)
Qmax change from baseline to 3, 6 and 12 months.
Post-Void Residual Volume (PVR)
PVR change from baseline to 3, 6 and 12 months.
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