INTUPRO in the Treatment of Benign Prostatic Hyperplasia-Related Symptoms
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: INTUPRO ionic fluid.
- Who it may be relevant to
- Registry conditions: BPH (Benign Prostatic Hyperplasia), BPH, BPH With Other Lower Urinary Tract Symptoms. Basic parameters: from 45 years · Male.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Turkey (Türkiye)
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
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.
Overview
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.
Detailed description
The main goal of this study is to determine how well INTUPRO improves urinary symptoms in patients with benign prostatic hyperplasia (BPH). Effectiveness will be measured by changes in the International Prostate Symptom Score (IPSS), a standard questionnaire used to assess urinary symptoms.
Another goal of this study is to evaluate the safety of INTUPRO. This includes monitoring and recording all side effects, complications, or other medical problems that occur during the procedure and during the follow-up period after treatment.
This study is planned to last approximately one year; each patient will be followed for 3 months after treatment. Enrollment of 30 patients is expected.
Interventions
- Device INTUPRO ionic fluid
Under TRUS imaging, a fixed dose of the ablative agent will be administered to patients by the physician via needle. Each patient will receive a total of 4-10 mL ionic fluid , administered as two separate 2-5 mL injections into each side of the prostatic urethra.
Primary outcome measures
- Change in Urinary Symptoms (IPSS Score) [Time frame: 3 months]
- Procedure-Related and Post-Procedure Complications [Time frame: 3 months]
Secondary outcome measures (9)
- Procedure-Related Pain (Wong-Baker Pain Scale) [Time frame: 3 months]
- Urinary Incontinence Symptoms (ICIQ-UI) [Time frame: 3 months]
- Sexual Function (IIEF Score) [Time frame: 3 months]
- Retrograde Ejaculation [Time frame: 3 months]
- Quality of Life Related to Urinary Symptoms (IPSS-QoL) [Time frame: 3 months]
- Uroflowmetry [Time frame: 3 months]
- Pressure-Flow Study (If Performed) [Time frame: 3 months]
- Presence of prostate tissue ablation [Time frame: 3 months]
- Post-Procedure Urinary Catheterization Time [Time frame: 3 months]
Eligibility 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Turkey (Türkiye) · 1 center
- Koç University Hospital Research Center — Istanbul
Identifiers
NCT: NCT07381127 · INTUMO-003