Status:
TERMINATED
Transurethral Vapor Enucleation Resection of the Prostate (TVERP), Bipolar TURis and HoLEP
Lead Sponsor:
Olympus Surgical Technologies Europe
Conditions:
Benign Prostatic Hypertrophy
Eligibility:
MALE
22-75 years
Phase:
NA
Brief Summary
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 (B...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
August 27 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2022
Estimated Enrollment :
29 Patients enrolled
Trial Details
Trial ID
NCT04398420
Start Date
August 27 2020
End Date
August 1 2022
Last Update
January 9 2023
Active Locations (3)
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1
Renmin Hospital,Wuhan University
Wuhan, Hubei, China, 430060
2
West China Hospital, Sichuan University
Chengdu, Sichuan, China, 310003
3
The First Affiliated Hospital, College of Medicine, Zhejiang University
Hangzhou, Zhejiang, China, 310003