AQUABEAM Robotic System and Ultrasound Accessories (AQUA Study)

What this Trial Is About

Lower urinary symptoms (LUTS) commonly affect older men and tend to increase in frequency and severity with age, particularly due to bladder outlet obstruction from benign prostatic enlargement (BPE), also known as benign prostatic hyperplasia (BPH). This trial evaluates the safety and effectiveness of the third generation AQUABEAM Robotic System and Apogee 2300 Ultrasound System for treating LUTS caused by BPH. The study aims to compare the percentage of patients discharged on the day of surgery among different groups undergoing aquablation with this system. The intervention involves a minimally invasive surgical procedure using the AQUABEAM device, which uses an ultrasound-guided water jet to precisely remove prostate tissue through a transurethral approach. The system integrates cystoscopic visualization, ultrasound imaging, and advanced planning software to tailor the treatment to each patient's anatomy. Patients will receive aquablation therapy under general or spinal anesthesia, followed by catheter placement and monitored bladder irrigation. The procedure aims to minimize bleeding and allow same-day discharge when possible. Participants will undergo baseline assessments including urinary flow measurements, symptom scoring with the International Prostate Symptom Score (IPSS), and prostate size measurement via transrectal ultrasound. Follow-up visits will occur three months after the procedure to evaluate symptom improvement, urinary function, and safety outcomes such as adverse events. The study will monitor changes in IPSS scores and the rate of serious adverse effects immediately after surgery. Total participation is approximately three months post-treatment, with data collected to assess the therapy's impact on urinary symptoms and quality of life.

AQUABEAM® Robotic System and Ultrasound Accessories