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Transperineal Irreversible Electroporation for Benign Prostatic Hyperplasia

RecruitingNAAges 50 Years - anyMaleFirst Affiliated Hospital of Zhejiang University
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In plain words

What the trial is, and whether it could suit you

This clinical trial focuses on men with benign prostatic hyperplasia (BPH), a condition in which an enlarged prostate causes urinary problems. The goal is to test a non-thermal ablation technique called irreversible electroporation (IRE), delivered with a steep pulse therapy system, for treating BPH. The main questions it aims to answer are: 1. How many participants have improved urine flow 3 months after treatment? 2. How do urinary symptoms, quality of life, and prostate size change after treatment? 3. What side effects occur, and how serious are they? Participants will be asked to: * undergo the IRE procedure: needle electrodes are placed in the prostate through the perineum under ultrasound guidance, and short electric pulses ablate the enlarged tissue; * attend follow-up visits at 1 and 3 months after the procedure for urine flow tests, symptom questionnaires, and ultrasound mea

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: 1. patients with BPH diagnosed through digital rectal examination, B-mode ultrasound and urinary flow rate. 2. international prostate symptom score(IPSS)\>=12. 3. Maximum urinary flow rate between \>5ml/s and \<15ml/s with a minimum voided volume โ‰ฅ 150ml. 4. Age โ‰ฅ 50 years old. 5. Subjects are willing to participate and have signed the informed consent form. Exclusion Criteria: 1. Patients with acute or severe urinary tract infections. 2. Patients clinically diagnosed with prostate cancer. 3. Patients with neurogenic bladder or bladder dysfunction due to other factors. 4. Patients with urethral stricture. 5. Patients who have undergone previous prostatectomy (TURP), enucleation, or laser surgery. 6. Patients with implanted pacemakers or metal replacements in the pelvis or hip joints. 7. Patients who cannot tolerate general anesthesia or surgery due to severe systemic diseases, heart diseases, pulmonary insufficiency, failure of vital organs, or other reasons. 8. Patients in the trial group who have taken medications that can affect BPH symptoms within 3 months of postoperative follow-up. 9. Patients who have participated in other drug trials or medical device clinical trials within 3 months prior to enrollment. 10. Patients deemed unsuitable for participation in this clinical trial by the investigator.
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What it tests

  • Composite steep-pulse therapeutic device (CNP-III)
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Where

10 sites
The First Affiliated Hospital of University of Science and Technology of China
Hefei, China
Fujian Provincial Hospital
Fuzhou, China
Quanzhou First Hospital
Quanzhou, China
Zhongshan Hospital Affiliated to Xiamen University
Xiamen, China
Zhangzhou Hospital of Fujian Province
Zhangzhou, China
Shanghai Sixth People's Hospital Affiliated to Shanghai Jiao Tong University
Shanghai, China
Shanghai Tenth People's Hospital
Shanghai, China
Shanghai Jiading District Central Hospital
Shanghai, China

โ€ฆand 2 more on ClinicalTrials.gov.

๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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