INTUPRO for benign prostate enlargement symptoms

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

Participants receive a single INTUPRO treatment on Day 1 and return for follow-up visits at Day 30 and Day 90, including symptom questionnaires and prostate MRI. Effectiveness is measured primarily by changes in the International Prostate Symptom Score (IPSS) and by catheter removal, urinary flow, and frequency of nocturia. Safety monitoring will record all side effects and complications during the procedure and the 3-month follow-up. The study plans to enroll about 30 outpatient participants and follow each patient for approximately three months after treatment.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* • 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 Criteria:

* 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

Where it's running

• Koç University Hospital Research Center
  Istanbul, Turkey (Türkiye) Recruiting

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.