INTUPRO for benign prostate enlargement 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.
This trial will try INTUPRO to see if it improves urinary symptoms in men 45 and older with enlarged prostates (BPH).
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 31 (estimated) |
| Ages | 45 Years and up |
| Sex | Male |
| Sponsor | inTumo Therapeutics, Inc. Industry-sponsored |
| Drugs / interventions | radiation |
| Locations | 1 site (Istanbul) |
| Trial ID | NCT07381127 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are men aged 45 or older with prostate volume >30 g, an IPSS of 12 or higher, obstructive urinary symptoms, the ability to consent, and willingness to attend follow-up visits.
Not a fit: Patients with urethral stricture, bladder stones, a prostate volume ≥120 g, a median lobe, or a history of bladder or kidney cancer or related surgeries are excluded and unlikely to benefit from this procedure.
Why it matters
Potential benefit: If successful, INTUPRO could reduce reliance on Foley catheters and improve urinary flow, urgency, frequency, and nighttime urination, improving patients' quality of life.
How similar studies have performed: This INTUPRO ionic-fluid procedure is relatively novel and there are limited published data on identical approaches.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Istanbul
- Koç University Hospital Research Center — Istanbul, Turkey (Türkiye) (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.