Evaluating Safety and Effectiveness of INTUPRO Ionic Fluid for Treating Urinary Symptoms in Men with Benign Prostatic Hyperplasia

What this Trial Is About

Researchers are evaluating the safety and effectiveness of INTUPRO, an ionic fluid treatment, in improving urinary symptoms for men with Benign Prostatic Hyperplasia BPH. This study aims to find out if INTUPRO can help remove the Foley catheter, improve urinary flow, reduce waking at night to urinate, and lessen urinary hesitancy, urgency, and frequency. The study will use the International Prostate Symptom Score IPSS to measure changes in symptoms and will also monitor safety by recording any side effects or complications. Participants will receive INTUPRO treatment on the first day, where a fixed dose of 4-10 mL ionic fluid is injected under ultrasound guidance into each side of the prostatic urethra. Follow-up visits will occur at 30 and 90 days after treatment to check progress, perform tests, and conduct a Prostate MRI to assess the treatment area. This is a single-arm, single-center study involving about 30 male patients. During the study, participants will undergo clinical assessments including symptom questionnaires, pain scales, urinary incontinence and sexual function evaluations, uroflowmetry, and possibly pressure-flow studies. Researchers will track procedure-related pain, complications, catheterization time, and quality of life related to urinary symptoms over three months. The total participation time is approximately one year, with each patient followed for three months after treatment to monitor outcomes and safety.

INTUPRO in the Treatment of Benign Prostatic Hyperplasia-Related Symptoms