NCT07381127

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.

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 31 (estimated)
• Sponsor: inTumo Therapeutics, Inc. · Industry
• Sex: Male
• Age: 45 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The main goal of this study is to determine how well INTUPRO improves urinary symptoms in patients with benign prostatic hyperplasia (BPH). Effectiveness will be measured by changes in the International Prostate Symptom Score (IPSS), a standard questionnaire used to assess urinary symptoms. Another goal of this study is to evaluate the safety of INTUPRO. This includes monitoring and recording all side effects, complications, or other medical problems that occur during the procedure and during the follow-up period after treatment. This study is planned to last approximately one year; each patient will be followed for 3 months after treatment. Enrollment of 30 patients is expected.

Conditions

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

Interventions

Type	Name	Description
DEVICE	INTUPRO 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.

Timeline

• Start date: 2025-03-04
• Primary completion: 2027-12-01
• Completion: 2027-12-01
• First posted: 2026-02-02
• Last updated: 2026-02-02

Locations

1 site across 1 country: Turkey (Türkiye)