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

Olympus

Status: Terminated

Conditions: Benign Prostatic Hypertrophy

Treatments: Device: HoLEP; Device: TVERP; Device: TURis

Study type: Interventional

Funder types: Industry

Identifiers

NCT04398420

TVERP01

Details and patient eligibility

About

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.

Enrollment: 29 patients

Sex: Male

Ages: 22 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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29 participants in 3 patient groups

TVERP

Active Comparator group

Treatment:

Device: TVERP

TURis

Active Comparator group

Treatment:

Device: TURis

HoLEP

Active Comparator group

Treatment:

Device: HoLEP