A Phase 2 interventional study of Irreversible electroporation and Standard Medication in Lower Urinary Tract Symptoms, sponsored by Changhai Hospital. Status unknown at 1 site in China. Open to male participants aged 45 Years and older. Per ClinicalTrials.gov, last updated 2018-02-28.
Sponsored by Changhai Hospital · Phase 2, Interventional, and Treatment
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.
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.
Exclusion Criteria:
Subjects will receive irreversible electroporation of the prostate
Device: Irreversible electroporation
Subjects will receive either α-blocker or 5α reductase monotherapy or combination therapy.
Drug: Standard Medication
The subject will receive Irreversible electroporation procedure which is a novel ablation modality using electric pulses to create nanoscale defects in the cell membrane.
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
Maximum flow rate will be measured using urinary flow study
Time frame: Measured at baseline and 1, 3, 6 months during follow-up
The changes of IPSS scores between baseline and during follow-up
Measured using a standard IPSS scoring system
Time frame: Measured at baseline and 1, 3, 6 months during follow-up
The changes of IIEF scores between baseline and during follow-up
Measured using a standard IIEF scoring system
Time frame: 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
The data will be captured during pressure flow study
Time frame: Measured at baseline and 3, 6 months during follow-up
The changes of post void residual volume (ml) between baseline and follow-up
Post void residual volume (ml) will be measured via ultrasound
Time frame: Measured at baseline and 1, 3, 6 months during follow-up
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.
Time frame: Measured at baseline and 1, 3, 6 during follow-up
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Changhai Hospital