RecruitingNot ApplicableNCT07381127

INTUPRO in the Treatment of Benign Prostatic Hyperplasia-Related Symptoms

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.

Sponsor

inTumo Therapeutics, Inc.

Enrollment

31 participants

Start Date

Mar 4, 2025

Study Type

INTERVENTIONAL

Conditions

BPH (Benign Prostatic Hyperplasia)BPH BPH With Other Lower Urinary Tract Symptoms

Summary

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.

Eligibility

Sex: MALEMin Age: 45 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a medical device called INTUPRO ionic fluid for people with bph, bph (benign prostatic hyperplasia), and other related conditions. The study is currently recruiting participants at 1 location.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEINTUPRO ionic fluid

Under TRUS imaging, a fixed dose of the ablative agent will be administered to patients by the physician via needle. Each patient will receive a total of 4-10 mL ionic fluid , administered as two separate 2-5 mL injections into each side of the prostatic urethra.