Irreversible Electroporation Versus Standard Medication for Benign Prostatic Obstruction
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|ClinicalTrials.gov Identifier: NCT03448510|
Recruitment Status : Not yet recruiting
First Posted : February 28, 2018
Last Update Posted : February 28, 2018
|Condition or disease||Intervention/treatment||Phase|
|Lower Urinary Tract Symptoms||Device: Irreversible electroporation Drug: Standard Medication||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Irreversible electroporation (IRE) is a novel ablation modality using electric pulses to create nanoscale defects in the cell membrane.|
|Masking:||Single (Outcomes Assessor)|
|Masking Description:||The data will be analyzed in a blinded manner.|
|Official Title:||The Safety and Efficacy of Irreversible Electroporation Versus Standard Medication for the Treatment of Benign Prostatic Obstruction: a Randomized Controlled Trial|
|Estimated Study Start Date :||April 1, 2018|
|Estimated Primary Completion Date :||January 31, 2019|
|Estimated Study Completion Date :||May 30, 2019|
Experimental: Irreversible electroporation treatment
Subjects will receive irreversible electroporation of the prostate
Device: 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.
Active Comparator: standard medication group
Subjects will receive either α-blocker or 5α reductase monotherapy or combination therapy.
Drug: Standard Medication
The subject will be prescribed with α-blocker or/and 5α-reductase inhibitors.
- The changes of maximum flow rate (ml/s) between baseline and during follow-up [ Time Frame: Measured at baseline and 1, 3, 6 months during follow-up ]Maximum flow rate will be measured using urinary flow study
- The changes of IPSS scores between baseline and during follow-up [ Time Frame: Measured at baseline and 1, 3, 6 months during follow-up ]Measured using a standard IPSS scoring system
- The changes of IIEF scores between baseline and during follow-up [ Time Frame: Measured at baseline and 1, 3, 6 months 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 [ Time Frame: Measured at baseline and 3, 6 months 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 [ Time Frame: Measured at baseline and 1, 3, 6 months during follow-up ]Post void residual volume (ml) will be measured via ultrasound
- The changes of prostate volume (ml) between baseline and follow-up [ Time Frame: Measured at baseline and 1, 3, 6 during 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03448510
|Changhai Hospital||Not yet recruiting|
|Shanghai, Shanghai, China, 200433|
|Contact: Haifeng Wang, MD, PhD 13681750891 firstname.lastname@example.org|
|Contact: Qi-Xiang Song, MD, PhD 15021223013 email@example.com|