NCT03157726

Brief Summary

The study is a multicentric randomized control trial with 4-year follow-up comparing perioperative and postoperative outcomes for transurethral plasmakinetic enucleation of prostate(TUKEP) and transurethral resection of prostate(TURP). The investigators recruit patient with benign prostatic hyperplasia(BPH) as the object of study. TURP is set as control group . Meanwhile TUKEP is set as test group. Six affiliated hospitals will participate in this study. Through analyzing the perioperative and postoperative data between TUKEP group and TURP group, The investigators purpose demonstrating superiority of safety, efficacy and economic benefit in TUKEP group.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
294

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2017

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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 11, 2017

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 17, 2017

Completed
5 months until next milestone

Study Start

First participant enrolled

October 11, 2017

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 6, 2020

Completed
12 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2021

Completed
Last Updated

March 3, 2020

Status Verified

January 1, 2020

Enrollment Period

2.7 years

First QC Date

May 11, 2017

Last Update Submit

March 1, 2020

Conditions

Benign Prostatic Hyperplasia

Keywords

benign prostatic hyperplasiamulticenter randomized control clinical trialtransurethral plasmakinetic enucleation of prostatetransurethral resection of prostate

Outcome Measures

Primary Outcomes (2)

  • Qmax(Maximum urinary flow rate)

    Maximum urinary flow rate was measured at 1, 3, 6, 12, 24, 36 and 48-month postoperatively

    4 years

  • IPSS (International Prostate Symptom Score )

    International Prostate Symptom Score was measured at 1, 3, 6, 12, 24, 36 and 48-month postoperatively

    4 years

Secondary Outcomes (13)

  • QOL(Quality of Life)

    4 years

  • International Index Of Erectile Function (IIEF-5)

    4 years

  • Operation time

    up to 24 hours

  • Postoperative hospital stay

    1 month

  • Indwelling catheter time

    1 month

  • +8 more secondary outcomes

Study Arms (2)

TUKEP(enucleation of prostate)

ACTIVE COMPARATOR

Patients accept TUKEP (transurethral plasmakinetic enucleation of prostate). The TUKEP procedure requires the use of a resectoscope, camera system and irrigation fluid. The system consists of a generator unit and a wire loop with an electrical current running, the beak of resectoscope was used to enucleation of prostate and the bipolar loop was used to cutting and coagulation, There are many manufacturers of Bipolar TURP systems. Any bipolar plasmakinetic system approved by the CFDA (Chinese food and drug administration) may be used for the study. The bipolar plasmakinetic system was set at 160 W for cutting and 100 W for coagulation.

Procedure: Transurethral plasmakinetic enucleation of prostate

TURP(resection of prostate)

ACTIVE COMPARATOR

Patients accept TURP (transurethral resection of prostate). The TURP procedure requires the use of a resectoscope, camera system and irrigation fluid. The system consists of a generator unit and a wire loop with an electrical current running through the loop used to cut prostate tissue and cauterize. Prostate tissue is cut away in small pieces and removed at the end of the procedure using irrigation. There are many manufacturers of TURP systems. Any monopolar and bipolar loop system approved by the CFDA (Chinese food and drug administration) may be used for the study. The bipolar plasmakinetic system was set at 160 W for cutting and 100 W for coagulation.

Procedure: transurethral resection of prostate

Interventions

Transurethral plasmakinetic enucleation of prostatePROCEDURE

Transurethral plasmakinetic enucleation of prostate(PAKEP),an operation mode devised by Liu Chunxiao Team in southern medical university urology department. The theory of the operation is using transurethral resectoscope instead of the finger in the open operation, to find the surgical capsule of prostate and to peel the hyperplastic prostate gland visually in a antidromic way.

Also known as: TUKEP
TUKEP(enucleation of prostate)
transurethral resection of prostatePROCEDURE

Transurethral resection of prostate(TURP), a kind of mature minimally invasive surgery of prostate , taking the place of the traditional open surgery in 1930s , still is the "gold standard" operation for surgical treatment of BPH.

Also known as: TURP
TURP(resection of prostate)

Eligibility Criteria

Age50 Years - 80 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnose as BPH
  • Between 50 and 80 year-old
  • Prostate volume less than 120g
  • Meet any conditions (1). International Prostate Symptom Score (IPSS),≥12 quality of life score (QOL) ≥4分 (2).Maximum urinary flow rate (Qmax) 15 ml/s or less (urine flow more than 150 ml) (3).Medication is not efficient (4).Repeated urinary retention (extubation failure more than one) (5).Schafer≥grade 2
  • The American association of anesthesia score (ASA) class 1 to 3
  • Sign the informed consent voluntarily and will be willing to follow-up

You may not qualify if:

  • Combined with central nervous system lesions (such as cerebrovascular accident, Parkinson, multiple sclerosis, cauda equina injury, spinal cord lesions, etc.) and neurogenic bladder;
  • The combination of advanced malignant tumor or chronic wasting disease;
  • Patients with severe cardiopulmonary disease or severe mental disorders;
  • Acute urinary tract infection, urethral stricture;
  • There is a history of prostate and bladder surgery;
  • Combined with severe coagulopathy;
  • Postoperative pathology confirmed prostate cancer;
  • Poor compliance, and can not be followed up.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Zhujiang Hospital of Southern Medical University

Guangzhou, Guangdong, 510282, China

RECRUITING

MeSH Terms

Conditions

Prostatic Hyperplasia

Interventions

Transurethral Resection of Prostate

Condition Hierarchy (Ancestors)

Prostatic DiseasesGenital Diseases, MaleGenital DiseasesUrogenital DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

ProstatectomyUrologic Surgical Procedures, MaleUrologic Surgical ProceduresUrogenital Surgical ProceduresSurgical Procedures, Operative

Central Study Contacts

Shaobo Zheng, M.D

CONTACT

136028883561h1h1h864@sina.com

ChunXiao Liu, M.D., Ph.D

CONTACT

13302296795liuchx888@hotmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 11, 2017

First Posted

May 17, 2017

Study Start

October 11, 2017

Primary Completion

June 6, 2020

Study Completion

June 1, 2021

Last Updated

March 3, 2020

Record last verified: 2020-01

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)