Transurethral Vapor Enucleation Resection of the Prostate (TVERP), Bipolar TURis and HoLEP
NCT ID: NCT04398420
Last Updated: 2023-01-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
NA
29 participants
INTERVENTIONAL
2020-08-27
2022-08-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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TVERP
TVERP
Transurethral Vapor Enucleation Resection of the prostate
TURis
TURis
Transurethral Vapor Enucleation Resection of the prostate
HoLEP
HoLEP
Transurethral Vapor Enucleation Resection of the prostate
Interventions
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TVERP
Transurethral Vapor Enucleation Resection of the prostate
TURis
Transurethral Vapor Enucleation Resection of the prostate
HoLEP
Transurethral Vapor Enucleation Resection of the prostate
Eligibility Criteria
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Inclusion Criteria
2. The patient should be a candidate for surgical treatment of bladder outlet obstruction.
3. Patients with BPH and surgical indication (refractory to medical treatment, refractory or recurrent urinary retention, recurrent haematuria, bladder stones, recurrent infections, hydronephrosis)
4. Prostate volume ˃30 and ≤80 ml
5. PSA \<4 ng/ml in patients above 55 years old and a prostate cancer risk less than 35%. (Prostate cancer risk calculator).
6. IPSS ≥8 (moderate to severe)
7. Indications for TURIS
8. maximum urinary flow (Qmax) \<10ml/second
9. A written informed consent signed by the patient (including patient's agreement to randomization and treatment).
Exclusion Criteria
2. 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.
3. 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
4. Previous neurogenic lower urinary tract dysfunction.
5. Patients with urethral strictures
6. Severe pulmonary disease and cardio-vascular disorder 、Coagulopathy，and contraindications to anesthesia and surgery.
7. Concurrent participation in any other clinical study
8. 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.
9. Previous bladder outlet surgery.
10. A clinically significant acute illness.
11. Intake of medication in which the principle investigator considers to preclude enrollment into the trial.
12. Known disease of the central or peripheral nervous system.
13. Any clinical evidence of carcinoma of the prostate.
14. HIV positive or any other immunosuppressive disorder.
15. Psychological/psychiatric disease /Known cognitive disorder.
22 Years
75 Years
MALE
No
Sponsors
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Olympus Surgical Technologies Europe
INDUSTRY
Responsible Party
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Locations
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Renmin Hospital,Wuhan University
Wuhan, Hubei, China
West China Hospital, Sichuan University
Chengdu, Sichuan, China
The First Affiliated Hospital, College of Medicine, Zhejiang University
Hangzhou, Zhejiang, China
Countries
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Other Identifiers
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TVERP01
Identifier Type: -
Identifier Source: org_study_id
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