INTUPRO in the Treatment of Benign Prostatic Hyperplasia-Related Symptoms

Официальное название

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.

Обзор

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.

Подробное описание

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.

Вмешательства

• Устройство 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.

Первичные конечные точки

• Change in Urinary Symptoms (IPSS Score) [Срок оценки: 3 months]
• Procedure-Related and Post-Procedure Complications [Срок оценки: 3 months]

Вторичные конечные точки (9)

• Procedure-Related Pain (Wong-Baker Pain Scale) [Срок оценки: 3 months]
• Urinary Incontinence Symptoms (ICIQ-UI) [Срок оценки: 3 months]
• Sexual Function (IIEF Score) [Срок оценки: 3 months]
• Retrograde Ejaculation [Срок оценки: 3 months]
• Quality of Life Related to Urinary Symptoms (IPSS-QoL) [Срок оценки: 3 months]
• Uroflowmetry [Срок оценки: 3 months]
• Pressure-Flow Study (If Performed) [Срок оценки: 3 months]
• Presence of prostate tissue ablation [Срок оценки: 3 months]
• Post-Procedure Urinary Catheterization Time [Срок оценки: 3 months]

Критерии участия

Критерии включения

• • 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Turkey (Türkiye) · 1 центр

• Koç University Hospital Research Center — Istanbul

Идентификаторы

NCT: NCT07381127 · INTUMO-003

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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