The Safety and Effectiveness of Steep Pulse Therapy System for the Ablation of Benign Prostatic Hyperplasia

Официальное название

Prospective, Multicenter, Randomized, Controlled, and Superiority Clinical Trial on the Safety and Effectiveness of Steep Pulse Therapy System for the Ablation of Benign Prostatic Hyperplasia

Обзор

The goal of this clinical trial is to assess the efficacy of steep pulse ablation in treating benign prostatic hyperplasia (BPH) and to evaluate its safety profile in treating BPH. The main questions it aims to answer are: 1. whether steep pulse ablation can effectively manage BPH symptoms and to investigate any potential safety concerns associated with its use in treating BPH. 2. If steep pulse ablation can perform superior effect than Tamsulosin Hydrochloride in treating BPH. Participants will be asked to do: 1. Participants will be given Tamsulosin Hydrochloride or undergo steep pulse ablation. 2. Participants will be followed up after 1 month and 3 month after taking drug or undergo ablation for test and relative examinations.

Вмешательства

• Устройство steep pulse therapy system
  1. Use steep pulse system to ablate the transitional zone of the prostate to treat BPH 2. The steep pulse generator employs irreversible electroporation technology, which involves inserting electrodes into the tumor and delivering high-voltage electrical pulses to create nanoscale permanent pores on the lipid bilayer of tumor cell membranes. This disrupts the intracellular balance and induces cell apoptosis
• Препарат Tamsulosin Hydrochloride
  1. use Tamsulosin Hydrochloride Sustained-Release Capsules to treat BPH 2. the brand name is Harnal® 3. the specification is 0.2mg per capsule

Первичные конечные точки

• The change in maximum urinary flow rate [Срок оценки: 3 months]

Вторичные конечные точки (1)

• changes in the international prostate symptoms score(IPSS) before and after treatment [Срок оценки: screening, 30 days and 3 months]

Критерии участия

Критерии включения

• patients with BPH diagnosed through digital rectal examination, B-mode ultrasound and urinary flow rate.
• international prostate symptom score(IPSS)>=12.
• Maximum urinary flow rate between >5ml/s and <15ml/s with a minimum voided volume ≥ 150ml.
• Age ≥ 50 years old.
• Subjects are willing to participate and have signed the informed consent form.

Критерии исключения

• Patients with acute or severe urinary tract infections.
• Patients clinically diagnosed with prostate cancer.
• Patients with neurogenic bladder or bladder dysfunction due to other factors.
• Patients with urethral stricture.
• Patients who have undergone previous prostatectomy (TURP), enucleation, or laser surgery.
• Patients with implanted pacemakers or metal replacements in the pelvis or hip joints.
• Patients who cannot tolerate general anesthesia or surgery due to severe systemic diseases, heart diseases, pulmonary insufficiency, failure of vital organs, or other reasons.
• Patients in the trial group who have taken medications that can affect BPH symptoms within 3 months of postoperative follow-up.
• Patients who have participated in other drug trials or medical device clinical trials within 3 months prior to enrollment.
• Patients deemed unsuitable for participation in this clinical trial by the investigator.

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Оценка устройства

Центры проведения

Китай · 1 центр

• The First Affiliated Hospital of Zhejiang University — Ханчжоу

Идентификаторы

NCT: NCT06867315 · steeppulse-prostate

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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