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

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.

Status
Terminated
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04398420
Enrollment
29
Registered
2020-05-21
Start date
2020-08-27
Completion date
2022-08-01
Last updated
2023-01-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Benign Prostatic Hypertrophy

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 (BPH) patients with prostate ˃30 and ≤80 ml compare to TURis or HoLEP surgery methods.

Interventions

DEVICETURis

Transurethral Vapor Enucleation Resection of the prostate

DEVICEHoLEP

Transurethral Vapor Enucleation Resection of the prostate

DEVICETVERP

Transurethral Vapor Enucleation Resection of the prostate

Sponsors

Olympus Surgical Technologies Europe
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
MALE
Age
22 Years to 75 Years
Healthy volunteers
No

Inclusion criteria

1. Male, age older than 22 and younger than 75 years of age 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

1. Patients under anti-inflammatory or steroid therapy 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.

Design outcomes

Primary

MeasureTime frame
change of blood levelMeasurement of pre-operative and immediate post-operative period (6 hours and 24 hours) hemoglobin and hematocrit levels will be performed.

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026