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.

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.

Study Overview

• Status: Terminated
• Conditions: Benign Prostatic Hypertrophy
• Intervention / Treatment: Device: TVERP; Device: TURis; Device: HoLEP

• Study Type: Interventional
• Enrollment (Actual): 29
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Hubei
    • Wuhan, Hubei, China, 430060
      • Renmin Hospital,Wuhan University
  • Sichuan
    • Chengdu, Sichuan, China, 310003
      • West China Hospital, Sichuan University
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310003
      • The First Affiliated Hospital, College of Medicine, Zhejiang University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 22 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: TVERP	Device: TVERP; Transurethral Vapor Enucleation Resection of the prostate
Active Comparator: TURis	Device: TURis; Transurethral Vapor Enucleation Resection of the prostate
Active Comparator: HoLEP	Device: HoLEP; Transurethral Vapor Enucleation Resection of the prostate

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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.

Collaborators and Investigators

• Sponsor: Olympus Surgical Technologies Europe

Study record dates

Study Major Dates

• Study Start (Actual): August 27, 2020
• Primary Completion (Actual): August 1, 2022
• Study Completion (Actual): August 1, 2022

Study Registration Dates

• First Submitted: May 12, 2020
• First Submitted That Met QC Criteria: May 20, 2020
• First Posted (Actual): May 21, 2020

Study Record Updates

• Last Update Posted (Estimate): January 9, 2023
• Last Update Submitted That Met QC Criteria: January 4, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Prostatic Diseases; Pathological Conditions, Anatomical; Prostatic Hyperplasia; Hypertrophy
• Other Study ID Numbers: TVERP01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No