INTUPRO in the Treatment of Benign Prostatic Hyperplasia-Related Symptoms

NCT07381127 | Recruiting

• 1 other identifier: INTUMO-003
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

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

Keywords

procedure; needle; benign prostate hyperplasia; moderate sedation; outpatient

Outcome Measures

Primary Outcomes (2)

• Change in Urinary Symptoms (IPSS Score)

  The change in the International Prostate Symptom Score (IPSS) from baseline will be evaluated after treatment. IPSS scores recorded at the screening visit will be compared with scores obtained at the 1-month and 3-month follow-up visits. A reduction in the IPSS score at 1 month and 3 months compared with baseline will be considered a primary outcome measure.

  3 months

• Procedure-Related and Post-Procedure Complications

  Complications related to the procedure and the postoperative period will be assessed at 1 day, 1 month, and 3 months after treatment. The following complications will be specifically monitored: * Urinary retention * Urinary tract infection, suggested by a positive urine culture * Urosepsis * Blood in the urine (hematuria) * Perineal hematoma

  3 months

Secondary Outcomes (9)

• Procedure-Related Pain (Wong-Baker Pain Scale)

  3 months

• Urinary Incontinence Symptoms (ICIQ-UI)

  3 months

• Sexual Function (IIEF Score)

  3 months

• Retrograde Ejaculation

  3 months

• Quality of Life Related to Urinary Symptoms (IPSS-QoL)

  3 months

Study Arms (1)

Intervention arm

EXPERIMENTAL

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

Device: INTUPRO ionic fluid

Interventions

INTUPRO ionic fluid DEVICE

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.

Intervention arm

Eligibility Criteria

• Age: 45 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• inTumo Therapeutics, Inc.: lead

Study Sites (1)

Koç University Hospital Research Center

Istanbul, 34010, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Prostatic Hyperplasia

Condition Hierarchy (Ancestors)

Prostatic Diseases; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 15, 2026
• First Posted: February 2, 2026
• Study Start: March 4, 2025
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: February 2, 2026

Record last verified: 2026-01

Locations

TU (1)