Irreversible Electroporation Versus Standard Medication for Benign Prostatic Obstruction

NCT03448510 | Unknown Phase 2

• 1 other identifier: IRE-2018
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Lower Urinary Tract Symptoms

Keywords

lower urinary tract symptoms; male; benign prostatic obstruction; irreversible electroporation; urodynamics

Outcome Measures

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 (5)

• The changes of IPSS scores between baseline and during follow-up

  Measured at baseline and 1, 3, 6 months during follow-up

• The changes of IIEF scores between baseline and during follow-up

  Measured at baseline and 1, 3, 6 months during follow-up

• The changes of maximum detrusor pressure at maximum flow rate between baseline and during follow-up

  Measured at baseline and 3, 6 months during follow-up

• The changes of post void residual volume (ml) between baseline and follow-up

  Measured at baseline and 1, 3, 6 months during follow-up

• The changes of prostate volume (ml) between baseline and follow-up

  Measured at baseline and 1, 3, 6 during follow-up

Study Arms (2)

Irreversible electroporation treatment

EXPERIMENTAL

Subjects will receive irreversible electroporation of the prostate

Device: Irreversible electroporation

standard medication group

ACTIVE COMPARATOR

Subjects will receive either α-blocker or 5α reductase monotherapy or combination therapy.

Drug: Standard Medication

Interventions

Irreversible electroporation DEVICE

The subject will receive Irreversible electroporation procedure which is a novel ablation modality using electric pulses to create nanoscale defects in the cell membrane.

Irreversible electroporation treatment

Standard Medication DRUG

The subject will be prescribed with α-blocker or/and 5α-reductase inhibitors.

standard medication group

Eligibility Criteria

• Age: 45 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male, 45 years or older.
• The presence of voiding symptoms, i.e. slow stream, intermittent stream, hesitancy, straining, etc.
• Qmax ≥ 5 mL/s and ≤ 15 mL/s with minimum voided volume of 125 mL or more during flow study.
• The presence of bladder outlet obstruction during pressure-flow study.
• International Prostatic Symptom Score (IPSS) ≥ 12 at screening.
• Prostate volume ≥ 30 ml (using a transrectal ultrasound approach).
• Total serum prostatic specific antigen (PSA) ≥ 1.5 ng/mL and ≤ 10 ng/mL at screening.
• Subject is able to communicate and complete the questionnaires properly.
• Written informed consent.

You may not qualify if:

• Diagnosis or suspicion of bladder, prostate, urethral or pelvic tumor.
• Patients with arrhythmia or history of cardiac pacemaker implantation.
• Known lower urinary tract or pelvic surgical history.
• Voiding symptoms as a result of urethral stricture, stone diseases, chronic prostatitis, space-occupying lesions etc.
• Known neurogenic or congenital lower urinary tract dysfunction.
• Rigid or flexible cystoscopy examination within the past 7 days at screening.
• Existence of anatomical abnormalities of the urinary tract (e.g. diverticulum of the bladder or urethra, ectopic ureteral orifice etc.).
• The presence of acute conditions, such as, urinary tract infection, fever, heart failure etc.
• Patients with poor compliance or cognitive competence.

Sponsors & Collaborators

• Changhai Hospital: lead

Study Sites (1)

Changhai Hospital

Shanghai, Shanghai Municipality, 200433, China

Location

Related Publications (1)

• 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.

  PMID: 27217767 BACKGROUND

MeSH Terms

Conditions

Lower Urinary Tract Symptoms

Interventions

Electroporation

Condition Hierarchy (Ancestors)

Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cytological Techniques; Clinical Laboratory Techniques; Investigative Techniques; Electrochemical Techniques

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The data will be analyzed in a blinded manner.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Model Details: Irreversible electroporation (IRE) is a novel ablation modality using electric pulses to create nanoscale defects in the cell membrane.

Study Record Dates

• First Submitted: February 22, 2018
• First Posted: February 28, 2018
• Study Start: April 1, 2018
• Primary Completion: January 31, 2019
• Study Completion: May 30, 2019
• Last Updated: February 28, 2018

Record last verified: 2018-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)