This trial is comparing the effects and safety in treating men with benign prostatic hyperplasia between high freqnence irreversible electroporation and trans urethral resection prostate.
A Prospective, Single-center, Randomized Controlled Trial Comparing the Efficacy and Safety of High-Frequency Irreversible Electroporation and Trans Urethral Resection Prostate for Benign Prostatic Hyperplasia One hundred and seventy-six patients with benign prostatic hyperplasia will include in this study. The clinical trial validation process will be as follows: (1) all patients are randomly divided into two arms: arm 1, high-freqnence irreversible electroporation; arm 2, transurethral resection prostate. The primary outcome is the change in maximum urinary flow rate and urinary symptoms by questionnaire of International Prostate Symptom Score at 3 months after surgical treatment.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
118
High freqnence Irreversible electroporation will be performed via the perineum with the guidance of ultrasound under general anaesthesia to the patient with benign prostatic hyperplasia
Trans urethral resection prostate will be performed under general anaesthesia to the patient with benign prostatic
Haifeng Wang
Shanghai, China
RECRUITINGmaximum urinary flow rate(Qmax)
the change from baseline in maximum urinary flow rate(Qmax)
Time frame: 1 and 3 months after surgical treatment
urination function(evaluated by International prostate symptom score, IPSS)
the change from baseline in IPSS (International prostate symptom score)
Time frame: 1 and 3 months after surgical treatment
sexual function evaluated by International Index of Erectile Function Questionnaire-5 (IIEF-5)
the change from baseline in International Index of Erectile Function Questionnaire-5 (IIEF-5)
Time frame: 1 and 3 months after surgical treatment
sexual function evaluated by the International Consultation on Incontinence Questionnaire Male Sexual Matters Associated with Lower Urinary Tract Symptoms Module (ICIQ--MLUTSsex)
the change from baseline in International Consultation on Incontinence Questionnaire Male Sexual Matters Associated with Lower Urinary Tract Symptoms Module (ICIQ--MLUTSsex)
Time frame: 1 and 3 months after surgical treatment
post-void residual urine volume (PVRU)
the change from the baseline in the post-void residual urine volume (PVRU)
Time frame: 1 and 3 months after surgical treatment
urinary incontinence evaluated by ICIQ (International Consultation on Incontinence Questionnaire)
the change from baseline in by ICIQ (International Consultation on Incontinence Questionnaire)
Time frame: 1 and 3 months after surgical treatment
urinary incontinence evaluated by separate EPIC (Expanded Prostate Cancer Index Composite) pad-use item
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the change from the baseline in urinary incontinence, evaluated by separate EPIC (Expanded Prostate Cancer Index Composite) pad-use item
Time frame: 1 and 3 months after surgical treatment
quality of life (QOL) evaluated by IPSS QoL subscore
the change from the baseline in QOL, evaluated by IPSS QoL subscore
Time frame: 1 and 3 months after surgical treatment
quality of life (QOL) evaluated by Hospital Anxiety and Depression Scale (HADS))
the change from the baseline in QOL, evaluated by Hospital Anxiety and Depression Scale (HADS)
Time frame: 1 and 3 months after surgical treatment
perioperative parameters(operative time)
operative time
Time frame: 1 month
perioperative parameters(the postoperative hospital stay)
the postoperative hospital stay
Time frame: 1 month
perioperative parameters(haemoglobin declination)
haemoglobin declination
Time frame: 6 hours, 24 hours after surgical treatment
perioperative parameters(serum sodium declination)
serum sodium declination
Time frame: 6 hours, 24 hours after surgical treatment
perioperative parameters(catheterisation duration)
catheterisation duration
Time frame: 1 month
early postoperative urinary symptoms
include dysuria, urgency, or post micturition pain
Time frame: 1 and 3 months after surgical treatment
pain measured by a surgical pain scale
pain measured by a surgical pain scale range from 0 to 10
Time frame: 24 hours, 1 week, 1 month and 3 months
adverse event
including TUR syndrome, blood transfusion, clot retention, uti, transient incontience, retrograde ejaculation.
Time frame: 1 and 3 months after surgical treatment
voided volume
the change from the baseline in voided volume
Time frame: 1 and 3 months after surgical treatment