Actively Recruiting
INTUPRO in the Treatment of Benign Prostatic Hyperplasia-Related Symptoms
Led by inTumo Therapeutics, Inc. · Updated on 2026-02-02
31
Participants Needed
1
Research Sites
143 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official 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
- An International Prostate Symptom Score (IPSS) of 12 or higher
- Presence of obstructive urinary symptoms such as difficulty starting urination, leakage after voiding, or incomplete bladder emptying
- May include patients previously treated for prostate cancer with ongoing urinary problems
- 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 related surgeries
- Previous radiation therapy to the pelvic area
- Prior invasive surgical treatment for BPH symptoms
- Considered unable to tolerate the procedure by the Principal Investigator
- Cognitive impairment affecting ability to provide reliable data or complete study safely
- Bleeding disorders
- Allergy or intolerance to MRI contrast agents
- Significant medical conditions that could prevent benefit or increase risk, including active infection or kidney dysfunction
- Significant medical or psychiatric illness
- Participation in another ongoing clinical study that could affect outcomes
- Inability or unwillingness to undergo MRI during the study period
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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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