What this Trial Is About

Researchers are evaluating a new treatment called transperineal focal microwave ablation (TMA) for men with lower urinary tract symptoms caused by benign prostatic hyperplasia (BPH). This study is a phase 2 pilot trial conducted at a single institution, aiming to assess the effectiveness of TMA in reducing symptoms related to prostate enlargement. Current standard surgeries like transurethral resection and laser treatments can have significant side effects, so this study explores a less invasive alternative. The treatment involves a 3D ultrasound-guided procedure that uses a single needle to deliver microwave energy to the prostate transition zone, targeting the enlarged tissue. This focal thermal ablation is done with advanced imaging techniques, including ultrasound-MRI fusion and organ tracking. The procedure is minimally invasive, can be performed in an outpatient setting, and is intended to reduce complications compared to traditional surgeries. Participants will be monitored for changes in urinary symptoms using the International Prostate Symptom Score (IPSS) measured at the start and three months after treatment. The study includes evaluations of prostate volume, urine flow rate, and overall safety. Patients will have scheduled visits to assess treatment effects and side effects, with a focus on functional outcomes related to urination and quality of life over the study period.

Evaluation of the Functional Outcomes After Bilateral, 3D Ultrasound-guided Focal Thermal Ablation of the Prostate Transition Zone, in Patients with Benign Prostatic Hyperplasia-related Obstruction