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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
Led by inTumo Therapeutics, Inc. · Updated on 2026-02-02
31
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and effectiveness of INTUPRO, an ionic fluid treatment, in improving urinary symptoms for men with Benign Prostatic Hyperplasia (BPH). This study aims to find out if INTUPRO can help remove the Foley catheter, improve urinary flow, reduce waking at night to urinate, and lessen urinary hesitancy, urgency, and frequency. The study will use the International Prostate Symptom Score (IPSS) to measure changes in symptoms and will also monitor safety by recording any side effects or complications. Participants will receive INTUPRO treatment on the first day, where a fixed dose of 4-10 mL ionic fluid is injected under ultrasound guidance into each side of the prostatic urethra. Follow-up visits will occur at 30 and 90 days after treatment to check progress, perform tests, and conduct a Prostate MRI to assess the treatment area. This is a single-arm, single-center study involving about 30 male patients. During the study, participants will undergo clinical assessments including symptom questionnaires, pain scales, urinary incontinence and sexual function evaluations, uroflowmetry, and possibly pressure-flow studies. Researchers will track procedure-related pain, complications, catheterization time, and quality of life related to urinary symptoms over three months. The total participation time is approximately one year, with each patient followed for three months after treatment to monitor outcomes and safety.
CONDITIONS
Brief Title
INTUPRO in the Treatment of Benign Prostatic Hyperplasia-Related Symptoms
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male patient aged 45 years or older
- Prostate volume greater than 30 grams
- International Prostate Symptom Score (IPSS) of 12 or higher
- Presence of obstructive urinary symptoms such as difficulty starting urination, urine leakage after voiding, or feeling of incomplete bladder emptying
- Life expectancy of at least 3 months
- Ability to understand study information and provide written informed consent
- Willingness and ability to comply with all study procedures and follow-up visits
You will not qualify if you...
- Urethral stricture
- Bladder stones
- Prostate volume 120 grams or greater
- Presence of a prostate median lobe
- History of bladder or kidney cancer or prior surgery related to these conditions
- Previous radiation therapy to the pelvic region
- Prior invasive surgical treatment for BPH symptoms
- Principal Investigator's judgment that patient would not tolerate the procedure
- Cognitive impairment interfering with data reliability or study completion
- Bleeding disorders
- Known allergy or intolerance to MRI contrast agents
- Significant concurrent medical conditions that could prevent benefit or increase risk
- Significant medical or psychiatric illness
- Participation in another ongoing clinical study that could affect outcomes
- Inability or unwillingness to undergo MRI examinations during the study period
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Single treatment visit
Participants receive the INTUPRO ionic fluid treatment administered through two injections into each side of the prostatic urethra under ultrasound guidance.
1 visit (in-person)
Duration - 3 months
Participants are monitored for safety and effectiveness of the treatment including urinary symptoms, side effects, and complications for 3 months after treatment.
Multiple follow-up visits over 3 months
Trial Site Locations
Total: 1 location
1
Koç University Hospital Research Center
Istanbul, Turkey (Türkiye), 34010
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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