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New treatment option for BPH (Benign Prostatic Hyperplasia)
Official title INTUPRO in the Treatment of Benign Prostatic Hyperplasia-Related Symptoms
ClinicalTrials.gov ID: NCT07381127
What this study is testing
- What it's testing
- 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?
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 45 and older, men only
You may be able to join 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...
- Life expectancy of at least 3 months
You likely can't join 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
See the full eligibility 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...
- 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
- 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 how well it works 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...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Istanbul, Turkey (Türkiye)
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling male, 45 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Istanbul, Turkey (Türkiye). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.