NCT04398420

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
29

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2020

Typical duration for not_applicable

Geographic Reach
1 country

3 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 12, 2020

Completed
9 days until next milestone

First Posted

Study publicly available on registry

May 21, 2020

Completed
3 months until next milestone

Study Start

First participant enrolled

August 27, 2020

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2022

Completed
Last Updated

January 9, 2023

Status Verified

January 1, 2023

Enrollment Period

1.9 years

First QC Date

May 12, 2020

Last Update Submit

January 4, 2023

Conditions

Benign Prostatic Hypertrophy

Outcome Measures

Primary Outcomes (1)

  • 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.

Study Arms (3)

TVERP

ACTIVE COMPARATOR
Device: TVERP

TURis

ACTIVE COMPARATOR
Device: TURis

HoLEP

ACTIVE COMPARATOR
Device: HoLEP

Interventions

TVERPDEVICE

Transurethral Vapor Enucleation Resection of the prostate

TVERP
TURisDEVICE

Transurethral Vapor Enucleation Resection of the prostate

TURis
HoLEPDEVICE

Transurethral Vapor Enucleation Resection of the prostate

HoLEP

Eligibility Criteria

Age22 Years - 75 Years
Sexmale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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).

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Renmin Hospital,Wuhan University

Wuhan, Hubei, 430060, China

Location

West China Hospital, Sichuan University

Chengdu, Sichuan, 310003, China

Location

The First Affiliated Hospital, College of Medicine, Zhejiang University

Hangzhou, Zhejiang, 310003, China

Location

MeSH Terms

Conditions

Prostatic Hyperplasia

Condition Hierarchy (Ancestors)

Prostatic DiseasesGenital Diseases, MaleGenital DiseasesUrogenital DiseasesMale Urogenital Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 12, 2020

First Posted

May 21, 2020

Study Start

August 27, 2020

Primary Completion

August 1, 2022

Study Completion

August 1, 2022

Last Updated

January 9, 2023

Record last verified: 2023-01

Locations

CN(3)