A Study to Evaluate the Safety and Efficacy of Ionic Fluid in Treating Symptoms in Patients With Benign Prostatic Hyperplasia. A Prospective, Single-arm, Single-center Clinical Study.
The goal of this clinical trial is to determine whether INTUPRO can improve the quality of life in patients with Benign Prostate Hyperplasia (BPH). The main questions it aims to answer are: Can INTUPRO treatment lead to the removal of the Foley catheter? Can INTUPRO treatment improve urinary flow? Can INTUPRO treatment lower or minimize waking during sleep to urinate? Can INTUPRO reduce urinary hesitancy, urgency and frequency? Participants will: Receive INTUPRO treatment on Day 1. Visit at Day 30 and Day 90 for checkups, tests and Prostate MRI.
• • Male patient aged 45 years or older
‣ Prostate volume greater than 30 grams
⁃ An International Prostate Symptom Score (IPSS) of 12 or higher
⁃ Presence of obstructive urinary symptoms, such as difficulty starting urination, leakage of urine after voiding, or a feeling of incomplete bladder emptying.
∙ This criterion may include patients who have previously been diagnosed with prostate cancer and completed treatment, but are experiencing urinary problems.
• Life expectancy of at least 3 months
• Ability to understand the study information and provide written informed consent
• Willingness and ability to comply with all study requirements, including procedures, clinical assessments, and follow-up visits