An interventional study of Transurethral plasmakinetic enucleation of prostate and transurethral resection of prostate in Benign Prostatic Hyperplasia, sponsored by Zhujiang Hospital. Status unknown at 1 site in China. Open to male participants aged 50 Years to 80 Years. Per ClinicalTrials.gov, last updated 2020-03-03.
Sponsored by Zhujiang Hospital · Not applicable, Interventional, and Treatment
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.
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.
783 studies on the registry are indexed under Prostatic Hyperplasia; 174 are open to participants now.
This study's planned enrollment of 294 is above the median of 97 across 593 interventional studies indexed under Prostatic Hyperplasia.
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Exclusion Criteria:
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
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 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
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
Qmax(Maximum urinary flow rate)
Maximum urinary flow rate was measured at 1, 3, 6, 12, 24, 36 and 48-month postoperatively
Time frame: 4 years
IPSS (International Prostate Symptom Score )
International Prostate Symptom Score was measured at 1, 3, 6, 12, 24, 36 and 48-month postoperatively
Time frame: 4 years
QOL(Quality of Life)
The Quality of Life Score was measured at 1, 3, 6, 12, 24, 36 and 48-month postoperatively
Time frame: 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.
Time frame: 4 years
Operation time
operation time
Time frame: up to 24 hours
Postoperative hospital stay
Postoperative hospital stay
Time frame: 1 month
Indwelling catheter time
The time of indwelling catheter post-operation
Time frame: 1 month
Postoperative irrigation
The time of Postoperative irrigation
Time frame: 1 month
Decrease in Haemoglobin in 24 hours post-operation
Compared with the baseline, to demonstrate the blood loss during operation
Time frame: 1 month
Retreatment rate
The ratio of patient who need reoperation to remove urinary tract obstruction
Time frame: 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.
Time frame: 4 years
Hospitalization expenses
Total costs for BPH treatment during Hospitalization. The cost of other diseases should be excluded
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 4 years
Plan to share: No
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Zhujiang Hospital