Clinical trial NCT03157726: Transurethral Plasmakinetic Enucleation of Prostate Versus Transurethral Resection of Prostate
Official title: Transurethral Plasmakinetic Enucleation of Prostate Versus Transurethral Resection of Prostate: A Multi-center Randomized Control Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Benign Prostatic Hyperplasia
Keywords: benign prostatic hyperplasia
multicenter randomized control clinical trial
transurethral plasmakinetic enucleation of prostate
transurethral resection of prostate
Lead sponsor: Zhujiang Hospital
Sponsor class: OTHER
Collaborators: name: Nanfang Hospital, Southern Medical University
name: The First Affiliated Hospital of Anhui Medical University
name: The First Affiliated Hospital of Nanchang University
name: Fourth Affiliated Hospital of Guangxi Medical University
name: First Affiliated Hospital of Fujian Medical University
First posted: 2017-05-17
Enrollment: 294
Sex: MALE
Minimum age (years): 50
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Qmax(Maximum urinary flow rate)
timeFrame: 4 years
measure: IPSS (International Prostate Symptom Score )
timeFrame: 4 years
Secondary outcomes:
measure: QOL(Quality of Life)
timeFrame: 4 years
measure: International Index Of Erectile Function (IIEF-5)
timeFrame: 4 years
measure: Operation time
timeFrame: up to 24 hours
measure: Postoperative hospital stay
timeFrame: 1 month
measure: Indwelling catheter time
timeFrame: 1 month
measure: Postoperative irrigation
timeFrame: 1 month
measure: Decrease in Haemoglobin in 24 hours post-operation
timeFrame: 1 month
measure: Retreatment rate
timeFrame: 4 years
measure: Prostate-specific antigen(PSA)
timeFrame: 4 years
measure: Hospitalization expenses
timeFrame: 1 month
measure: Prostate volume
timeFrame: 4 years
measure: Residual urine volume
timeFrame: 4 years
measure: Claviendindo classification
timeFrame: 4 years
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Zhujiang Hospital of Southern Medical University
state: Guangdong
Study officials:
References: