Back to resultsTransurethral Vapor Enucleation Resection of the Prostate (TVERP), Bipolar TURis and HoLEP
Primary Purpose
Benign Prostatic Hypertrophy
Status
Terminated
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
TVERP
TURis
HoLEP
Sponsored by
About this trial
This is an interventional treatment trial for Benign Prostatic Hypertrophy
Eligibility Criteria
Inclusion Criteria:
- Male, age older than 22 and younger than 75 years of age
- The patient should be a candidate for surgical treatment of bladder outlet obstruction.
- Patients with BPH and surgical indication (refractory to medical treatment, refractory or recurrent urinary retention, recurrent haematuria, bladder stones, recurrent infections, hydronephrosis)
- Prostate volume ˃30 and ≤80 ml
- PSA <4 ng/ml in patients above 55 years old and a prostate cancer risk less than 35%. (Prostate cancer risk calculator).
- IPSS ≥8 (moderate to severe)
- Indications for TURIS
- maximum urinary flow (Qmax) <10ml/second
- A written informed consent signed by the patient (including patient's agreement to randomization and treatment).
Exclusion Criteria:
- Patients under anti-inflammatory or steroid therapy
- 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.
- 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
- Previous neurogenic lower urinary tract dysfunction.
- Patients with urethral strictures
- Severe pulmonary disease and cardio-vascular disorder 、Coagulopathy，and contraindications to anesthesia and surgery.
- Concurrent participation in any other clinical study
- 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.
- Previous bladder outlet surgery.
- A clinically significant acute illness.
- Intake of medication in which the principle investigator considers to preclude enrollment into the trial.
- Known disease of the central or peripheral nervous system.
- Any clinical evidence of carcinoma of the prostate.
- HIV positive or any other immunosuppressive disorder.
- Psychological/psychiatric disease /Known cognitive disorder.
Sites / Locations
- Renmin Hospital,Wuhan University
- West China Hospital, Sichuan University
- The First Affiliated Hospital, College of Medicine, Zhejiang University
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Active Comparator
Arm Label
TVERP
TURis
HoLEP
Arm Description
Outcomes
Primary Outcome Measures
change of blood level
Secondary Outcome Measures
Full Information
NCT ID
NCT04398420
First Posted
May 12, 2020
Last Updated
January 4, 2023
Sponsor
Olympus Surgical Technologies Europe
1. Study Identification
Unique Protocol Identification Number
NCT04398420
Brief Title
Transurethral Vapor Enucleation Resection of the Prostate (TVERP), Bipolar TURis and HoLEP
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.
Study Type
Interventional
2. Study Status
Record Verification Date
January 2023
Overall Recruitment Status
Terminated
Why Stopped
Terminated due to low recruitment. FUP of enrolled patients will be performed until LPLV.
Study Start Date
August 27, 2020 (Actual)
Primary Completion Date
August 1, 2022 (Actual)
Study Completion Date
August 1, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Olympus Surgical Technologies Europe
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Benign Prostatic Hypertrophy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
29 (Actual)
8. Arms, Groups, and Interventions
Arm Title
TVERP
Arm Type
Active Comparator
Arm Title
TURis
Arm Type
Active Comparator
Arm Title
HoLEP
Arm Type
Active Comparator
Intervention Type
Device
Intervention Name(s)
TVERP
Intervention Description
Transurethral Vapor Enucleation Resection of the prostate
Intervention Type
Device
Intervention Name(s)
TURis
Intervention Description
Transurethral Vapor Enucleation Resection of the prostate
Intervention Type
Device
Intervention Name(s)
HoLEP
Intervention Description
Transurethral Vapor Enucleation Resection of the prostate
Primary Outcome Measure Information:
Title
change of blood level
Time Frame
Measurement of pre-operative and immediate post-operative period (6 hours and 24 hours) hemoglobin and hematocrit levels will be performed.
10. Eligibility
Sex
Male
Gender Based
Yes
Minimum Age & Unit of Time
22 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Male, age older than 22 and younger than 75 years of age
The patient should be a candidate for surgical treatment of bladder outlet obstruction.
Patients with BPH and surgical indication (refractory to medical treatment, refractory or recurrent urinary retention, recurrent haematuria, bladder stones, recurrent infections, hydronephrosis)
Prostate volume ˃30 and ≤80 ml
PSA <4 ng/ml in patients above 55 years old and a prostate cancer risk less than 35%. (Prostate cancer risk calculator).
IPSS ≥8 (moderate to severe)
Indications for TURIS
maximum urinary flow (Qmax) <10ml/second
A written informed consent signed by the patient (including patient's agreement to randomization and treatment).
Exclusion Criteria:
Patients under anti-inflammatory or steroid therapy
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.
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
Previous neurogenic lower urinary tract dysfunction.
Patients with urethral strictures
Severe pulmonary disease and cardio-vascular disorder 、Coagulopathy，and contraindications to anesthesia and surgery.
Concurrent participation in any other clinical study
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.
Previous bladder outlet surgery.
A clinically significant acute illness.
Intake of medication in which the principle investigator considers to preclude enrollment into the trial.
Known disease of the central or peripheral nervous system.
Any clinical evidence of carcinoma of the prostate.
HIV positive or any other immunosuppressive disorder.
Psychological/psychiatric disease /Known cognitive disorder.
Facility Information:
Facility Name
Renmin Hospital,Wuhan University
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430060
Country
China
Facility Name
West China Hospital, Sichuan University
City
Chengdu
State/Province
Sichuan
ZIP/Postal Code
310003
Country
China
Facility Name
The First Affiliated Hospital, College of Medicine, Zhejiang University
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310003
Country
China
12. IPD Sharing Statement
Learn more about this trial
Transurethral Vapor Enucleation Resection of the Prostate (TVERP), Bipolar TURis and HoLEP
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