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

Summary

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.

Timeline

Start

2020-08-20

Primary completion

2022-07-08

Completion

2022-07-08

Publications

• Background Roehrborn CG, Siami P, Barkin J, Damiao R, Major-Walker K, Morrill B, Montorsi F; CombAT Study Group. The effects of dutasteride, tamsulosin and combination therapy on lower urinary tract symptoms in men with benign prostatic hyperplasia and prostatic enlargement: 2-year results from the CombAT study. J Urol. 2008 Feb;179(2):616-21; discussion 621. doi: 10.1016/j.juro.2007.09.084. Epub 2007 Dec 21.

Drugs

Indications