The Safety and Efficacy of Irreversible Electroporation Versus Standard Medication for the Treatment of Benign Prostatic Obstruction: a Randomized Controlled Trial
Phase: PHASE2
Conditions: Lower Urinary Tract Symptoms
Sponsor: Changhai Hospital

The Study Design 
Title 
The safety and efficacy of irreversible electroporation versus standard medication for the treatment 
of benign prostatic obstruction: a randomized controlled trial 
Aims 
Aim: To investigate the safety and feasibility of irreversible electroporation for patients with benign 
prostatic obstruction.  
Inclusion Criteria 
1.
Male, 45 years or older.
2.
The presence of voiding symptoms, i.e. slow stream, intermittent stream, hesitancy, straining,
etc.
3.
Qmax ≥ 5 mL/s and ≤ 15 mL/s with minimum voided volume of 125 mL or more during
flow study.
4.
The presence of bladder outlet obstruction during pressure-flow study.
5.
International Prostatic Symptom Score (IPSS) ≥ 12 at screening.
6.
Prostate volume ≥ 30 ml (using a transrectal ultrasound approach).
7.
Total serum prostatic specific antigen (PSA) ≥ 1.5 ng/mL and ≤ 10 ng/mL at screening.
8.
Subject is able to communicate and complete the questionnaires properly.
9.
Written informed consent.
Exclusion Criteria 
1.
Diagnosis or suspicion of bladder, prostate, urethral or pelvic tumor.
2.
Patients with arrhythmia or history of cardiac pacemaker implantation.
3.
Known lower urinary tract or pelvic surgical history.
4.
Voiding symptoms as a result of urethral stricture, stone diseases, chronic prostatitis, space-
occupying lesions etc.
5.
Known neurogenic or congenital lower urinary tract dysfunction.

6. Rigid or flexible cystoscopy examination within the past 7 days at screening. 
7. Existence of anatomical abnormalities of the urinary tract (e.g. diverticulum of the bladder or 
urethra, ectopic ureteral orifice etc.). 
8. The presence of acute conditions, such as, urinary tract infection, fever, heart failure etc. 
9. Patients with poor compliance or cognitive competence. 
 
Study design flow diagram 
 
 
Primary Outcomes 

1. The changes of maximum flow rate (ml/s) between baseline and during follow-up: Maximum 
flow rate will be measured using urinary flow study. Measured at baseline and 1, 3, 6 months 
during follow-up. 
 
Secondary Outcomes 
1. The changes of IPSS scores between baseline and during follow-up: Measured using a standard 
IPSS scoring system. Measured at baseline and 1, 3, 6 months during follow-up.  
2. The changes of IIEF scores between baseline and during follow-up: Measured using a standard 
IIEF scoring system. Measured at baseline and 1, 3, 6 months during follow-up.  
3. The changes of maximum detrusor pressure at maximum flow rate between baseline and during 
follow-up: The data will be captured during pressure flow study. Measured at baseline and 3, 6 
months during follow-up.  
4. The changes of post void residual volume (ml) between baseline and follow-up: post void 
residual volume (ml) will be measured via ultrasound. Measured at baseline and 1, 3, 6 months 
during follow-up.  
5. The changes of prostate volume (ml) between baseline and follow-up: Prostate volume (ml) 
will be measured using transrectal prostate ultrasound and calculated as: prostate volume (ml) 
= length (mm) * width (mm) * height (mm) * 0.52. Measured at baseline and 1, 3, 6 during 
follow-up.  
6. The documentation of IRE procedure and medication related side effects. Measured at baseline 
and 1, 3, 6 months during follow-up.  
 
Brief Summary 
Irreversible electroporation (IRE) is a novel ablation modality using electric pulses to create 
nanoscale defects in the cell membrane. It has been verified to be safe on the treatment of prostate, 
lung, liver and kidney masses. The present is a randomized, controlled trial, with a main purpose of 
looking into the safety and feasibility of irreversible electroporation for patients with benign 
prostatic obstruction.  
 

Detailed Description 
Benign prostatic obstruction (BPO) is the main reason to cause lower urinary tract symptoms (LUTS) 
in aged male. Oral medications, such as,α1-adrenoceptor antagonist and 5α-reductase inhibitors 
are the mainstay treatment options. However, some patients can not tolerate long-term use, due to 
either side effects or limited efficacy. Though transurethral resection or enucleation of prostate 
usually achieve significant symptom improvement, it’s an end stage procedure and it is only 
reserved for carefully selected patients. 
 
The development of focal ablative therapy yields minimally invasive treatment option for primary 
tumors such as the liver, lung, pancreas, kidney, and prostate. Among the novel techniques are 
cryoablation, radiofrequency ablation (RFA), microwave ablation, and high-intensity focused 
ultrasonography. Irreversible electroporation (IRE) is a one of the ablation modalities using electric 
pulses to create nanoscale defects in the cell membrane. IRE is not dependent on thermal energy 
and is therefore causing minimum damage to the blood vessels, nerves and tissue architecture. The 
present is a randomized, controlled trial, with a main purpose of looking into the safety and 
feasibility of irreversible electroporation for patients with benign prostatic obstruction. 
 
Key Words 
male, lower urinary tract symptoms, benign prostatic obstruction, irreversible electroporation, 
urodynamics  
 
Description of Two Groups 
IRE group 
Oral medication group