Comparison of H-FIRE and TURP in Treating Benign Prostatic Hyperplasia

Study Overview
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Brief Summary
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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.

Detailed Description
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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 1, 3, 6, 12, 24, 36, 48 and 60 months after surgical treatment.

Official Title
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A Prospective, Single-center, Randomized Controlled Trial Comparing the Efficacy and Safety of High Freqnence Irreversible Electroporation and Trans Urethral Resection Prostate for Benign Prostatic Hyperplasia

Conditions
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Benign Prostatic Hyperplasia

Intervention / Treatment
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* Procedure: High freqnence Irreversible electroporation
* Procedure: Trans Urethral Resection Prostate


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age ≥ 40 years Qmax<15mL/s IPSS score >8 prostatic volume range of 30 to 100ml Exclusion Criteria: Patients with history of prostate cancer or patiens suspicious to have prostate cancer. Patients with neurogenic bladder. Patients with metal implants in their bodys(for example,cardiac pacemaker ) and/or with metal implants which located in the range from the first lumbar vertebra(L1) to the middle of femurs. patiens with previous history of prostatic or urethral surgery Patients with the judge that they are not suitable for this clinical trial

Ages Eligible for Study
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Minimum Age: 40 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: High Freqnence Irreversible Electroporation<br>Using high freqnence irreversible electroporation to treat patients with benign prostatic hyperplasia | Procedure: High freqnence Irreversible electroporation<br>* 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<br>|
| Active Comparator: Trans Urethral Resection Prostate<br>Using trans urethral resection prostate to treat patients with benign prostatic hyperplasia | Procedure: Trans Urethral Resection Prostate<br>* Trans urethral resection prostate will be performed under general anaesthesia to the patient with benign prostatic<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| maximum urinary flow rate(Qmax) | the change from baseline in maximum urinary flow rate(Qmax) | 1, 3, 6, 12 and 24 months after surgical treatment | 
| urination function(evaluated by International prostate symptom score, IPSS) | the change from baseline in IPSS (International prostate symptom score) | 1, 3, 6, 12 and 24 months after surgical treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 1, 3, 6, 12 and 24 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) | 1, 3, 6, 12 and 24 months after surgical treatment | 
| post-void residual urine volume (PVRU) | the post-void residual urine volume (PVRU) and the change from the baseline | 1, 3, 6, 12 and 24 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) | 1, 3, 6, 12 and 24 months after surgical treatment | 
| urinary incontinence evaluated by separate EPIC (Expanded Prostate Cancer Index Composite) pad-use item | evaluated by separate EPIC (Expanded Prostate Cancer Index Composite) pad-use item | 1 month after surgical treatment. | 
| urinary incontinence evaluated by separate EPIC (Expanded Prostate Cancer Index Composite) pad-use item | evaluated by separate EPIC (Expanded Prostate Cancer Index Composite) pad-use item | 3 months after surgical treatment. | 
| urinary incontinence evaluated by separate EPIC (Expanded Prostate Cancer Index Composite) pad-use item | evaluated by separate EPIC (Expanded Prostate Cancer Index Composite) pad-use item | 6 months after surgical treatment. | 
| urinary incontinence evaluated by separate EPIC (Expanded Prostate Cancer Index Composite) pad-use item | evaluated by separate EPIC (Expanded Prostate Cancer Index Composite) pad-use item | 12 months after surgical treatment. | 
| urinary incontinence evaluated by separate EPIC (Expanded Prostate Cancer Index Composite) pad-use item | evaluated by separate EPIC (Expanded Prostate Cancer Index Composite) pad-use item | 24 months after surgical treatment. | 
| quality of life (QOL) evaluated by IPSS QoL subscore | evaluated by IPSS QoL subscore | 1 month after surgical treatment. | 
| quality of life (QOL) evaluated by IPSS QoL subscore | evaluated by IPSS QoL subscore | 3 months after surgical treatment. | 
| quality of life (QOL) evaluated by IPSS QoL subscore | evaluated by IPSS QoL subscore | 6 months after surgical treatment. | 
| quality of life (QOL) evaluated by IPSS QoL subscore | evaluated by IPSS QoL subscore | 12 months after surgical treatment. | 
| quality of life (QOL) evaluated by IPSS QoL subscore | evaluated by IPSS QoL subscore | 24 months after surgical treatment. | 
| quality of life (QOL) evaluated by Hospital Anxiety and Depression Scale (HADS)) | evaluated by Hospital Anxiety and Depression Scale (HADS) | 1 month after surgical treatment. | 
| quality of life (QOL) evaluated by Hospital Anxiety and Depression Scale (HADS)) | evaluated by Hospital Anxiety and Depression Scale (HADS) | 3 months after surgical treatment. | 
| quality of life (QOL) evaluated by Hospital Anxiety and Depression Scale (HADS)) | evaluated by Hospital Anxiety and Depression Scale (HADS) | 6 months after surgical treatment. | 
| quality of life (QOL) evaluated by Hospital Anxiety and Depression Scale (HADS)) | evaluated by Hospital Anxiety and Depression Scale (HADS) | 12 months after surgical treatment. | 
| quality of life (QOL) evaluated by Hospital Anxiety and Depression Scale (HADS)) | evaluated by Hospital Anxiety and Depression Scale (HADS) | 24 months after surgical treatment. | 
| perioperative parameters(operative time) | operative time | 1 month | 
| perioperative parameters(the postoperative hospital stay) | the postoperative hospital stay | 1 month | 
| perioperative parameters(haemoglobin declination) | haemoglobin declination | 1 month | 
| perioperative parameters(serum sodium declination) | serum sodium declination | 1 month | 
| perioperative parameters(catheterisation duration) | catheterisation duration | 1 month | 
| early postoperative urinary symptoms | include dysuria, urgency, or post micturition pain | 6 months | 
| pain measured by a surgical pain scale | pain measured by a surgical pain scale range from 0 to 10 | 24 hours, 1 week, 1 month and 3 months | 
| adverse event | including TUR syndrome, blood transfusion, clot retention, uti, transient incontience. | any of the time within 6 months after surgical treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Benign Prostatic Hyperplasia, High freqnence Irreversible electroporation, Trans Urethral Resection Prostate