Back to resultsIrreversible Electroporation Versus Standard Medication for Benign Prostatic Obstruction
Primary Purpose
Lower Urinary Tract Symptoms
Status
Unknown status
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Irreversible electroporation
Standard Medication
Sponsored by
About this trial
This is an interventional treatment trial for Lower Urinary Tract Symptoms focused on measuring lower urinary tract symptoms, male, benign prostatic obstruction, irreversible electroporation, urodynamics
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Sites / Locations
- Changhai Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Irreversible electroporation treatment
standard medication group
Arm Description
Subjects will receive irreversible electroporation of the prostate
Subjects will receive either α-blocker or 5α reductase monotherapy or combination therapy.
Outcomes
Primary Outcome Measures
The changes of maximum flow rate (ml/s) between baseline and during follow-up
Maximum flow rate will be measured using urinary flow study
Secondary Outcome Measures
The changes of IPSS scores between baseline and during follow-up
Measured using a standard IPSS scoring system
The changes of IIEF scores between baseline and during follow-up
Measured using a standard IIEF scoring system
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
The changes of post void residual volume (ml) between baseline and follow-up
Post void residual volume (ml) will be measured via ultrasound
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03448510
Brief Title
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
2. Study Status
Record Verification Date
February 2018
Overall Recruitment Status
Unknown status
Study Start Date
April 1, 2018 (Anticipated)
Primary Completion Date
January 31, 2019 (Anticipated)
Study Completion Date
May 30, 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Changhai Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lower Urinary Tract Symptoms
Keywords
lower urinary tract symptoms, male, benign prostatic obstruction, irreversible electroporation, urodynamics
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Model Description
Irreversible electroporation (IRE) is a novel ablation modality using electric pulses to create nanoscale defects in the cell membrane.
Masking
Outcomes Assessor
Masking Description
The data will be analyzed in a blinded manner.
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Irreversible electroporation treatment
Arm Type
Experimental
Arm Description
Subjects will receive irreversible electroporation of the prostate
Arm Title
standard medication group
Arm Type
Active Comparator
Arm Description
Subjects will receive either α-blocker or 5α reductase monotherapy or combination therapy.
Intervention Type
Device
Intervention Name(s)
Irreversible electroporation
Intervention Description
The subject will receive Irreversible electroporation procedure which is a novel ablation modality using electric pulses to create nanoscale defects in the cell membrane.
Intervention Type
Drug
Intervention Name(s)
Standard Medication
Intervention Description
The subject will be prescribed with α-blocker or/and 5α-reductase inhibitors.
Primary Outcome Measure Information:
Title
The changes of maximum flow rate (ml/s) between baseline and during follow-up
Description
Maximum flow rate will be measured using urinary flow study
Time Frame
Measured at baseline and 1, 3, 6 months during follow-up
Secondary Outcome Measure Information:
Title
The changes of IPSS scores between baseline and during follow-up
Description
Measured using a standard IPSS scoring system
Time Frame
Measured at baseline and 1, 3, 6 months during follow-up
Title
The changes of IIEF scores between baseline and during follow-up
Description
Measured using a standard IIEF scoring system
Time Frame
Measured at baseline and 1, 3, 6 months during follow-up
Title
The changes of maximum detrusor pressure at maximum flow rate between baseline and during follow-up
Description
The data will be captured during pressure flow study
Time Frame
Measured at baseline and 3, 6 months during follow-up
Title
The changes of post void residual volume (ml) between baseline and follow-up
Description
Post void residual volume (ml) will be measured via ultrasound
Time Frame
Measured at baseline and 1, 3, 6 months during follow-up
Title
The changes of prostate volume (ml) between baseline and follow-up
Description
Prostate volume (ml) will be measured using transrectal prostate ultrasound and calculated as: prostate volume (ml) = length (mm) * width (mm) * height (mm) * 0.52.
Time Frame
Measured at baseline and 1, 3, 6 during follow-up
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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.
Facility Information:
Facility Name
Changhai Hospital
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200433
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Haifeng Wang, MD, PhD
Phone
13681750891
Email
446720864@qq.com
First Name & Middle Initial & Last Name & Degree
Qi-Xiang Song, MD, PhD
Phone
15021223013
Email
rex_song918@qq.com
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
27217767
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.
Results Reference
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Irreversible Electroporation Versus Standard Medication for Benign Prostatic Obstruction
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