Transurethral Plasmakinetic Enucleation of Prostate Versus Transurethral Resection of Prostate

Benign Prostatic Hyperplasia Clinical Trial

— ERP  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03157726
• Other study ID #: LC2016ZD025
• Status: Recruiting
• Phase: N/A
• Start date: October 11, 2017
• Est. completion date: June 1, 2021

Study information

• Verified date: January 2020
• Source: Zhujiang Hospital
• Contact: Shaobo Zheng, M.D
• Phone: 13602888356
• Email: 1h1h1h864[@]sina.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 294
• Est. completion date: June 1, 2021
• Est. primary completion date: June 6, 2020
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 50 Years to 80 Years

Eligibility

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? (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.

Related Conditions & MeSH terms

• Benign Prostatic Hyperplasia
• Hyperplasia
• Prostatic Hyperplasia

Intervention

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.
• 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.

Locations

Country	Name	City	State
China	Zhujiang Hospital of Southern Medical University	Guangzhou	Guangdong

Sponsors (6)

Lead Sponsor	Collaborator
Zhujiang Hospital	First Affiliated Hospital of Fujian Medical University, Fourth Affiliated Hospital of Guangxi Medical University, Nanfang Hospital of Southern Medical University, The First Affiliated Hospital of Anhui Medical University, The First Affiliated Hospital of Nanchang University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Qmax(Maximum urinary flow rate)	Maximum urinary flow rate was measured at 1, 3, 6, 12, 24, 36 and 48-month postoperatively	4 years
Primary	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	QOL(Quality of Life)	The Quality of Life Score was measured at 1, 3, 6, 12, 24, 36 and 48-month postoperatively	4 years
Secondary	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
Secondary	Operation time	operation time	up to 24 hours
Secondary	Postoperative hospital stay	Postoperative hospital stay	1 month
Secondary	Indwelling catheter time	The time of indwelling catheter post-operation	1 month
Secondary	Postoperative irrigation	The time of Postoperative irrigation	1 month
Secondary	Decrease in Haemoglobin in 24 hours post-operation	Compared with the baseline, to demonstrate the blood loss during operation	1 month
Secondary	Retreatment rate	The ratio of patient who need reoperation to remove urinary tract obstruction	4 years
Secondary	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
Secondary	Hospitalization expenses	Total costs for BPH treatment during Hospitalization. The cost of other diseases should be excluded	1 month
Secondary	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
Secondary	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
Secondary	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