Study of Ultra-minimally Invasive Prostate Dilation Using Ultrasound Guidance for Men With Significant Symptoms from Benign Prostatic Hyperplasia

What this Trial Is About

Researchers are evaluating the safety and effectiveness of a new ultra-minimally invasive procedure to widen the prostate using a special dilation catheter guided by real-time transrectal ultrasound TRUS in men with significant bladder outlet obstruction caused by benign prostatic hyperplasia BPH. This small, single-center, single-arm study plans to enroll 5 male participants aged 40 to 80 years who have moderate to severe urinary symptoms and confirmed prostate obstruction. The study aims to provide preliminary clinical evidence to support future larger studies. Participants will receive the prostate dilation treatment using a dedicated catheter under TRUS guidance without general anesthesia. The procedure is designed to relieve obstruction while preserving urinary and sexual function. After the treatment, participants will be followed up at 1, 3, and 6 months to assess symptom changes and safety. This includes monitoring for complications such as bladder neck contracture, retrograde ejaculation, prolonged urinary retention, stress urinary incontinence, bleeding, and tissue rupture that may require surgery. During the study, researchers will assess symptom improvement using the International Prostate Symptom Score IPSS, urinary flow rate Qmax, and pain levels using a visual analogue scale VAS. They will also explore changes in residual urine volume after urination and sexual function using established questionnaires. Safety will be closely monitored throughout the follow-up period. The total study duration for each participant will be at least 6 months post-treatment.

A Single-center, Single-arm Study to Evaluate the Safety and Efficacy of Ultra-minimally Invasive Prostate Dilation in Treating Patients With Significant Obstructive Symptoms Caused by Benign Prostatic Hyperplasia