Clinical trial NCT03448510: Irreversible Electroporation Versus Standard Medication for Benign Prostatic Obstruction
Official title: The Safety and Efficacy of Irreversible Electroporation Versus Standard Medication for the Treatment of Benign Prostatic Obstruction: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Lower Urinary Tract Symptoms
Keywords: lower urinary tract symptoms
male
benign prostatic obstruction
irreversible electroporation
urodynamics
Lead sponsor: Changhai Hospital
Sponsor class: OTHER
First posted: 2018-02-28
Enrollment: 100
Sex: MALE
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Irreversible electroporation (IRE) is a novel ablation modality using electric pulses to create nanoscale defects in the cell membrane.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: The changes of maximum flow rate (ml/s) between baseline and during follow-up
timeFrame: Measured at baseline and 1, 3, 6 months during follow-up
Secondary outcomes:
measure: The changes of IPSS scores between baseline and during follow-up
timeFrame: Measured at baseline and 1, 3, 6 months during follow-up
measure: The changes of IIEF scores between baseline and during follow-up
timeFrame: Measured at baseline and 1, 3, 6 months during follow-up
measure: The changes of maximum detrusor pressure at maximum flow rate between baseline and during follow-up
timeFrame: Measured at baseline and 3, 6 months during follow-up
measure: The changes of post void residual volume (ml) between baseline and follow-up
timeFrame: Measured at baseline and 1, 3, 6 months during follow-up
measure: The changes of prostate volume (ml) between baseline and follow-up
timeFrame: Measured at baseline and 1, 3, 6 during follow-up
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Changhai Hospital
state: Shanghai
Study officials:
References:
citation: Wagstaff PG, Buijs M, van den Bos W, de Bruin DM, Zondervan PJ, de la Rosette JJ, Laguna Pes MP. Irreversible electroporation: state of the art. Onco Targets Ther. 2016 Apr 22;9:2437-46. doi: 10.2147/OTT.S88086. eCollection 2016.