Transurethral Plasmakinetic Enucleation of Prostate Versus Transurethral Resection of Prostate (ERP)

Transurethral Plasmakinetic Enucleation of Prostate Versus Transurethral Resection of Prostate: A Multi-center Randomized Control Trial

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.

Study Overview

• Status: Unknown
• Conditions: Benign Prostatic Hyperplasia
• Intervention / Treatment: Procedure: Transurethral plasmakinetic enucleation of prostate; Procedure: transurethral resection of prostate

Detailed Description

Benign prostatic hyperplasia (BPH) is the most common disease of middle aged and elderly people which cause urinary tract symptoms (LUTS). transurethral resection of prostate(TURP) , began to replace the traditional open surgery in 1930s, still is as the "gold standard" operation for surgical treatment of BPH. However, compared with the traditional open operation, TURP has the following flaws:(1), due to the incomplete resection , maximum flow rate(Qmax) after TURP is lower than Qmax after open surgery. (2), there are serious complications, such as water intoxication and hemorrhage. (3) TURP has limitation to large prostate.

Transurethral plasmakinetic enucleation of prostate(TUKEP), an operation mode devised by Liu Chunxiao Team in southern medical university urology department, have offset the advantage of TURP. 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. One the one hand, TUKEP effectively solve the situation that It should repeatedly cut and stop bleeding and difficultly find the surgical capsule in TURP, which obviously reduce the rate of bleeding, prostatic capsula perforation, transurethral resection syndrome(TURS) and External sphincter injury. On the other hand, TUKEP is the minimally invasive surgery. It also achieves the effect of open surgery resolving the residual gland and reoperation post TURP.

The investigators plan to setup a a multicentric randomized control trial with 4-year follow-up comparing perioperative and postoperative outcomes for TUKEP and TURP. Through analyzing the perioperative and postoperative data between TUKEP group and TURP group, The purpose demonstrating superiority of safety, efficacy and economic benefit in TUKEP group.

• Study Type: Interventional
• Enrollment (Anticipated): 294
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510282
      • Recruiting
      • Zhujiang Hospital of Southern Medical University
      • Contact: Shaobo SB Zheng, M.D; Phone Number: +86-13602888356; Email: 1h1h1h864@sina.com
      • Contact: ChunXiao CX Liu, M.D., Ph.D; Phone Number: +86-13302296795; Email: liuchx888@hotmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

Inclusion Criteria:

1. Diagnose as BPH
2. Between 50 and 80 year-old
3. Prostate volume less than 120g
4. 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
5. The American association of anesthesia score (ASA) class 1 to 3
6. Sign the informed consent voluntarily and will be willing to follow-up

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: TUKEP(enucleation of prostate); 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; 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.; Other Names: TUKEP
Active Comparator: TURP(resection of prostate); 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; 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.; Other Names: TURP

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
QOL(Quality of Life)	The Quality of Life Score was measured at 1, 3, 6, 12, 24, 36 and 48-month postoperatively	4 years
International Index Of Erectile Function (IIEF-5)	International Index Of Erectile Function is a patient reporting outcomes measuring the erectile function at the baseline, 1,3,6,12, 24,36 and 48-month follow-up visits postoperatively.	4 years
Operation time	operation time	up to 24 hours
Postoperative hospital stay	Postoperative hospital stay	1 month
Indwelling catheter time	The time of indwelling catheter post-operation	1 month
Postoperative irrigation	The time of Postoperative irrigation	1 month
Decrease in Haemoglobin in 24 hours post-operation	Compared with the baseline, to demonstrate the blood loss during operation	1 month
Retreatment rate	The ratio of patient who need reoperation to remove urinary tract obstruction	4 years
Prostate-specific antigen(PSA)	To compare the Prostate-specific antigen between TUKEP and TURP at baseline, 1,3,6,12, 24,36 and 48-month follow-up visits.	4 years
Hospitalization expenses	Total costs for BPH treatment during Hospitalization. The cost of other diseases should be excluded	1 month
Prostate volume	Prostate volume is measured by ultrasound or MRI at the baseline, 1,3,6,12, 24,36 and 48-month follow-up visits	4 years
Residual urine volume	Residual urine in the bladder after urination(via abdominal ultrasonography) is measure at the baseline, 1,3,6,12, 24,36 and 48-month follow-up visits	4 years
Claviendindo classification	It is a grade for evaluating surgical complications at 1,3,6,12, 24,36 and 48-month follow-up visits	4 years

Collaborators and Investigators

• Sponsor: Zhujiang Hospital
• Collaborators: The First Affiliated Hospital of Anhui Medical University; The First Affiliated Hospital of Nanchang University; First Affiliated Hospital of Fujian Medical University; Nanfang Hospital of Southern Medical University; Fourth Affiliated Hospital of Guangxi Medical University

Study record dates

Study Major Dates

• Study Start (Actual): October 11, 2017
• Primary Completion (Anticipated): June 6, 2020
• Study Completion (Anticipated): June 1, 2021

Study Registration Dates

• First Submitted: May 11, 2017
• First Submitted That Met QC Criteria: May 15, 2017
• First Posted (Actual): May 17, 2017

Study Record Updates

• Last Update Posted (Actual): March 3, 2020
• Last Update Submitted That Met QC Criteria: March 1, 2020
• Last Verified: January 1, 2020

More Information

Terms related to this study

• Keywords: benign prostatic hyperplasia; transurethral resection of prostate; multicenter randomized control clinical trial; transurethral plasmakinetic enucleation of prostate
• Additional Relevant MeSH Terms: Pathologic Processes; Prostatic Diseases; Prostatic Hyperplasia; Hyperplasia
• Other Study ID Numbers: LC2016ZD025

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No