Irreversible Electroporation Versus Standard Medication for Benign Prostatic Obstruction
NCT ID: NCT03448510
Last Updated: 2018-02-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
100 participants
INTERVENTIONAL
2018-04-01
2019-05-30
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Irreversible electroporation treatment
Subjects will receive irreversible electroporation of the prostate
Irreversible electroporation
The subject will receive Irreversible electroporation procedure which is a novel ablation modality using electric pulses to create nanoscale defects in the cell membrane.
standard medication group
Subjects will receive either α-blocker or 5α reductase monotherapy or combination therapy.
Standard Medication
The subject will be prescribed with α-blocker or/and 5α-reductase inhibitors.
Interventions
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Irreversible electroporation
The subject will receive Irreversible electroporation procedure which is a novel ablation modality using electric pulses to create nanoscale defects in the cell membrane.
Standard Medication
The subject will be prescribed with α-blocker or/and 5α-reductase inhibitors.
Eligibility Criteria
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Inclusion Criteria
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
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.
45 Years
MALE
No
Sponsors
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Changhai Hospital
OTHER
Responsible Party
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Yinghao Sun
MD, PhD
Locations
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Changhai Hospital
Shanghai, Shanghai Municipality, China
Countries
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Facility Contacts
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Haifeng Wang, MD, PhD
Role: primary
Qi-Xiang Song, MD, PhD
Role: backup
References
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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.
Provided Documents
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Document Type: Study Protocol
Other Identifiers
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IRE-2018
Identifier Type: -
Identifier Source: org_study_id