CClinicalTrials.gg
TerminatedNCT04398420Updated Jan 9, 2023

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

An interventional study of TVERP and TURis in Benign Prostatic Hypertrophy, sponsored by Olympus Surgical Technologies Europe. Terminated at 3 sites in China. Open to male participants aged 22 Years to 75 Years. Per ClinicalTrials.gov, last updated 2023-01-09.

Sponsored by Olympus Surgical Technologies Europe · Not applicable, Interventional, and Treatment

Why this study was terminated
Terminated due to low recruitment. FUP of enrolled patients will be performed until LPLV.
Phase
Not applicable
Study type
Interventional
Enrollment
29
Allocation
Randomized
Ages
22 Years to 75 Years
Sex
Male
01

Study 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.

02

Conditions studied

  • Benign Prostatic Hypertrophy
03

In context

Prostatic Hyperplasia

783 studies on the registry are indexed under Prostatic Hyperplasia; 174 are open to participants now.

This study's enrollment of 29 is below the median of 97 across 593 interventional studies indexed under Prostatic Hyperplasia.

Browse Prostatic Hyperplasia studies →

Lead sponsor

Olympus Surgical Technologies Europe is the lead sponsor of 4 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
22 Years to 75 Years
Sexes eligible
Male
Accepts 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

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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
29 participants (actual)

Study arms

  • Active comparator
    TVERP

    Device: TVERP

  • Active comparator
    TURis

    Device: TURis

  • Active comparator
    HoLEP

    Device: HoLEP

Interventions

  • DeviceTVERP

    Transurethral Vapor Enucleation Resection of the prostate

  • DeviceTURis

    Transurethral Vapor Enucleation Resection of the prostate

  • DeviceHoLEP

    Transurethral Vapor Enucleation Resection of the prostate

06

What researchers measure

Primary outcomes

  1. 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.

07

Study locations

3 sites
  • Renmin Hospital,Wuhan University
    Wuhan, Hubei 430060, China
  • West China Hospital, Sichuan University
    Chengdu, Sichuan 310003, China
  • The First Affiliated Hospital, College of Medicine, Zhejiang University
    Hangzhou, Zhejiang 310003, China
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 9, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT04398420
Lead sponsor
Olympus Surgical Technologies Europe
Responsible party
Sponsor
First posted
May 21, 2020
Start date
Aug 27, 2020
Primary completion
Aug 1, 2022
Completion
Aug 1, 2022
Last update
Jan 9, 2023

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Jan 2023. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion