Composite Steep-pulseTreatment Device Used in Patients With Benign Prostatic Hyperplasia

Overview

This is a prospective, randomized, open-label, parallel-group, medication-control, superiority, multicenter clinical study trial. This study is studying the effects and safety in treating patients from nine different centers with Benign prostatic hyperplasia, employing Composite Steep-pulse(High-frequency irreversible electroporation) Treatment Apparatus. This device could cause cell irreversible electroporation, which leading necrosis of hyperplasia tissue cells. It also has the ability to prevent nerve,vessel, urethral and capsule unnecessary injury beside the ablation area. Composite Steep-pulse Treatment Apparatus will be used in patients who pass inclusion/exclusion criteria. Safety, quality of life, and urodynamic data analysis of each patient will be evaluated in each study patients.

Background: Benign prostatic hyperplasia (BPH) is a frequently-occurring disease in elderly males. The incidence of BPH is as high as 50% in males over 50 years old, while the incidence of BPH is as high as 80% in males over 80 years old. Current treatments for benign prostatic hyperplasia include oral drug therapy and surgical treatment. Drug therapy mainly includes:1. 5-α reductase inhibitors, such as Finasteride, which can delay or reduce the prostate volume, but it is required for 3-6 months to take effect, and patients need prolonged maintenance therapy. And it is contraindicated in patients with abnormal liver function, because the drug needs to be metabolized by the liver; 2. α receptor blockers, such as Tamsulosin and Doxazosin, which are able to relax the bladder neck, prostate and urethral smooth muscle, thereby reducing prostatic urethral resistance. It cannot reduce the size of the prostate gland, so it cannot fundamentally prevent the development of benign prostatic hyperplasia, while the effect on large volume benign prostatic hyperplasia is not obvious, and it is contraindicated in patients with renal insufficiency; 3 Traditional medicines, which can only be used as a supplementary drug. Surgery is the second-line treatment of BPH, and its standard procedure is transurethral resection of the prostate (TURP), which is considered to be the gold standard surgical procedure due to its exact efficacy and minimally invasive nature. However, large-scale retrospective studies have shown severe complications after TURP, especially TURP syndrome, postoperative urinary incontinence, urethral stricture, etc., hence there are still many concerns about the application of this procedure. Although plasma transurethral resection of the prostate and various laser prostate surgeries have sprung up in recent years, the basic surgical operation concept is not changed and the common problems existing in the procedure cannot be completely avoided. Luckily, with the development of technology, more and more new and effective treatments have emerged for BPH. In 2004, a new method using steep pulses to treat tumor was appeared. It showed that steep pulses could bring about Irreversible Electroporation (IRE) of cell, leading to necrosis of tumor or diseased cells. And it seemed to do no harms to the nerve and Vascular epithelial cell. The device of steep pulse had already been approved by FDA in 2011.However, this device of steep pulse has disadvantages like: (1)sever muscle contraction;(2)Urethral injury; (3)Capsule injury;(4)Nerve degeneration. This new device which is called Composite Steep-pulse(High-frequency irreversible electroporation) Treatment Device, may have the potential to conquer these disadvantages. Purpose: 1. This study will assess the efficacy of Composite Steep-pulse(High-frequency irreversible electroporation) Treatment Device in the treatment of BPH. 2. This study will assess the safety of Composite Steep-pulse(High-frequency irreversible electroporation) Treatment Device in the treatment of BPH. Methods: 1. patients recruitment 2. Irreversible Electroporation of malignant diseased Cell under Composite Steep-pulse Treatment for the patients with Benign Prostatic Hyperplasia; 3. Some factors such as prostate MRI, IPSS score, Qmax will be performed to evaluate the efficacy of the treatment. 4. Other factors such as the routine blood test, the routine urine test, the blood biochemistry test, ect. will be performed to evaluate the safety of the treatment.