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

Inclusion Criteria8

• 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

Exclusion Criteria15

Urethral stricture
Bladder stones
Prostate volume 120 grams or greater
Presence of a prostate median lobe
History of bladder cancer or kidney cancer, and/or prior surgery related to these conditions
Previous radiation therapy to the pelvic region
Prior invasive surgical treatment for BPH symptoms
The Principal Investigator believes the patient would not tolerate the procedure
Presence of a cognitive impairment that, in the opinion of the Principal Investigator, would interfere with the patient's ability to provide reliable data or to safely complete the study
Bleeding disorders
Known allergy or intolerance to MRI contrast agents required for imaging used to evaluate treatment effectiveness after ionic fluid application
Other significant concurrent medical conditions that, in the investigator's judgment, could prevent clinical benefit from the procedure or could place the patient or study objectives at risk (including, but not limited to, active infection, kidney dysfunction, or significant comorbidities)
Significant medical or psychiatric illness
Participation in another clinical study involving a device, drug, or procedure that has not been completed or that could affect the outcomes of this study
Inability or unwillingness to undergo MRI examinations during the study period for any reason

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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.