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

Benign Prostatic Hypertrophy Clinical Trial

Official title:

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.

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04398420
• Other study ID #: TVERP01
• Status: Terminated
• Phase: N/A
• Start date: August 27, 2020
• Est. completion date: August 1, 2022

Study information

• Verified date: January 2023
• Source: Olympus Surgical Technologies Europe
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 29
• Est. completion date: August 1, 2022
• Est. primary completion date: August 1, 2022
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 22 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Benign Prostatic Hypertrophy
• Hypertrophy
• Prostatic Hyperplasia

Intervention

Device:
• TVERP
Transurethral Vapor Enucleation Resection of the prostate
• TURis
Transurethral Vapor Enucleation Resection of the prostate
• HoLEP
Transurethral Vapor Enucleation Resection of the prostate

Locations

Country	Name	City	State
China	West China Hospital, Sichuan University	Chengdu	Sichuan
China	The First Affiliated Hospital, College of Medicine, Zhejiang University	Hangzhou	Zhejiang
China	Renmin Hospital,Wuhan University	Wuhan	Hubei

Sponsors (1)

Lead Sponsor	Collaborator
Olympus Surgical Technologies Europe

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.