Phase 1-2 Dose-escalation Study Evaluating Safety and Efficacy of HIFU Treatment for Benign Prostatic Hyperplasia Over 36 Months

What this Trial Is About

Benign prostatic hyperplasia BPH, also known as prostate adenoma, is a common non-cancerous enlargement of the prostate affecting mainly men over 40 years old. This condition often causes lower urinary tract symptoms LUTS such as difficulty starting urination, frequent urination, especially at night, and a decrease in urine flow. Researchers are evaluating the safety and effectiveness of a high-intensity focused ultrasound HIFU treatment specifically targeted to reduce prostate volume and improve urinary symptoms in men with BPH. The study uses HIFU, a technique that applies focused ultrasonic waves to heat and destroy targeted prostate tissue precisely without invasive surgery or radiation. This treatment is delivered endorectally using a specialized probe to target the affected prostate areas. The study observes patients at 3, 6, 12, 18, and 36 months after treatment to assess safety, symptom improvement, prostate size reduction, urinary flow changes, and sexual function. Participants will undergo various assessments including MRI scans, urinary flow measurements, and questionnaires on urinary symptoms, quality of life, and erectile and ejaculatory function. Researchers will monitor adverse events and treatment effects over 36 months. The study aims to gather detailed information about treatment safety and effectiveness through regular follow-up visits and evaluations.

Evaluating the Safety and Efficacy of the "HIFU" High-intensity Focused Ultrasound Treatment of Benign Prostatic Hyperplasia;