Transurethral Vapor Enucleation Resection of the Prostate (TVERP), Bipolar TURis and HoLEP

Study Overview
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Brief Summary
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To verify the safety and efficacy of the use of the plasma vaporisation button in Transurethral Vapor Enucleation and Resection of the prostate (TVERP) for treatment of Benign prostatic hypertrophy (BPH) patients with prostate ˃30 and ≤80 ml compare to TURis or HoLEP surgery methods.

Official Title
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Safety and Efficacy of TVERP in BPH Patients With Prostate Size ˃30 and ≤80 ml: a Comparison Study Between TVERP With the Plasma Vaporisation Button, Bipolar TURis and HoLEP Treatments.

Conditions
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Benign Prostatic Hypertrophy

Intervention / Treatment
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* Device: TVERP
* Device: TURis
* Device: HoLEP


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male, age older than 22 and younger than 75 years of age The patient should be a candidate for surgical treatment of bladder outlet obstruction. Patients with BPH and surgical indication (refractory to medical treatment, refractory or recurrent urinary retention, recurrent haematuria, bladder stones, recurrent infections, hydronephrosis) Prostate volume ˃30 and ≤80 ml PSA <4 ng/ml in patients above 55 years old and a prostate cancer risk less than 35%. (Prostate cancer risk calculator). IPSS ≥8 (moderate to severe) Indications for TURIS maximum urinary flow (Qmax) <10ml/second A written informed consent signed by the patient (including patient's agreement to randomization and treatment). Exclusion Criteria: Patients under anti-inflammatory or steroid therapy Patients under anti-coagulation at a level that could be exposed to a very high risk of complications based on a comprehensive pre-operatory evaluation. Renal insufficiency Serum creatinine (Scr) >1.5 x upper limit of normal (ULN); AST and ALT>2.5 x ULN;Total bilirubin >1.5 x ULN Previous neurogenic lower urinary tract dysfunction. Patients with urethral strictures Severe pulmonary disease and cardio-vascular disorder 、Coagulopathy，and contraindications to anesthesia and surgery. Concurrent participation in any other clinical study Any of the following within the 12 months prior to study: myocardial infarction, uncontrolled angina, coronary/peripheral artery bypass graft, symptomatic congestive heart failure, cerebrovascular accident or transient ischemic attack and 6 months for deep vein thrombosis or pulmonary embolism. Previous bladder outlet surgery. A clinically significant acute illness. Intake of medication in which the principle investigator considers to preclude enrollment into the trial. Known disease of the central or peripheral nervous system. Any clinical evidence of carcinoma of the prostate. HIV positive or any other immunosuppressive disorder. Psychological/psychiatric disease /Known cognitive disorder.

Ages Eligible for Study
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Minimum Age: 22 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: TVERP<br> | Device: TVERP<br>* Transurethral Vapor Enucleation Resection of the prostate<br>|
| Active Comparator: TURis<br> | Device: TURis<br>* Transurethral Vapor Enucleation Resection of the prostate<br>|
| Active Comparator: HoLEP<br> | Device: HoLEP<br>* Transurethral Vapor Enucleation Resection of the prostate<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change of blood level |  | Measurement of pre-operative and immediate post-operative period (6 hours and 24 hours) hemoglobin and hematocrit levels will be performed. |