Benign Prostatic HyperplasiaERPNCT03157726
Transurethral Plasmakinetic Enucleation of Prostate Versus Transurethral Resection of Prostate
A study testing Transurethral plasmakinetic enucleation of prostate and transurethral resection of prostate in people with Benign Prostatic Hyperplasia, run by Zhujiang Hospital at 1 site in China.
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). Read more about this study
- Who is it for?
- Ages 50 to 80 years, men only
- Conditions the study is for
- Benign Prostatic Hyperplasia
- What is being tested?
- Transurethral plasmakinetic enucleation of prostate and transurethral resection of prostate
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 294 participants
- Where
- 1 siteChina
- Study dates
- 11 Oct 2017to 1 Jun 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 80 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Zhujiang Hospital of Southern Medical University
Guangzhou, Guangdong, 510282
Shaobo SB Zheng, M.D, +86-13602888356, 1h1h1h864@sina.com
ChunXiao CX Liu, M.D., Ph.D, +86-13302296795, liuchx888@hotmail.com
About this study
Official title: 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.
Read the 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.
- Conditions
- Benign Prostatic Hyperplasia
- Being tested
- Transurethral plasmakinetic enucleation of prostate, transurethral resection of prostate
- Keywords
- benign prostatic hyperplasia, multicenter randomized control clinical trial, transurethral plasmakinetic enucleation of prostate, transurethral resection of prostate
- Medical subject headings
- Prostatic Hyperplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transurethral plasmakinetic enucleation of prostateProcedure or surgery
Also called TUKEP
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 prostateProcedure or surgery
Also called TURP
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Procedure: transurethral resection of prostate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Qmax(Maximum urinary flow rate)
Maximum urinary flow rate was measured at 1, 3, 6, 12, 24, 36 and 48-month postoperatively
Measured: 4 years
IPSS (International Prostate Symptom Score )
International Prostate Symptom Score was measured at 1, 3, 6, 12, 24, 36 and 48-month postoperatively
Measured: 4 years
Secondary outcomes (13)
QOL(Quality of Life)
The Quality of Life Score was measured at 1, 3, 6, 12, 24, 36 and 48-month postoperatively
Measured: 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.
Measured: 4 years
Operation time
operation time
Measured: up to 24 hours
Postoperative hospital stay
Postoperative hospital stay
Measured: 1 month
Indwelling catheter time
The time of indwelling catheter post-operation
Measured: 1 month
Postoperative irrigation
The time of Postoperative irrigation
Measured: 1 month
Decrease in Haemoglobin in 24 hours post-operation
Compared with the baseline, to demonstrate the blood loss during operation
Measured: 1 month
Retreatment rate
The ratio of patient who need reoperation to remove urinary tract obstruction
Measured: 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.
Measured: 4 years
Hospitalization expenses
Total costs for BPH treatment during Hospitalization. The cost of other diseases should be excluded
Measured: 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
Measured: 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
Measured: 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
Measured: 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2017
- Study start11 Oct 2017
- Primary completion6 Jun 2020 (estimated)
- Study completion1 Jun 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Benign Prostatic HyperplasiaStudies of the same condition, open and under way.
- More trials run by Zhujiang HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 294 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhujiang Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Nanfang Hospital, Southern Medical University, The First Affiliated Hospital of Anhui Medical University, The First Affiliated Hospital of Nanchang University, Fourth Affiliated Hospital of Guangxi Medical University, First Affiliated Hospital of Fujian Medical University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03157726
- Sponsor's protocol ID
- LC2016ZD025
- Acronym
- ERP
- Status last verified
- Jan 2020
- First submitted
- 11 May 2017
- Last updated
- 3 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transurethral Plasmakinetic Enucleation of Prostate Versus Transurethral Resection of Prostate: A Multi-center Randomized Control Trial
- ClinicalTrials.gov ID
- NCT03157726
- Acronym / sponsor ID
- ERP / LC2016ZD025
- Conditions
- Benign Prostatic Hyperplasia
- Keywords
- benign prostatic hyperplasia, multicenter randomized control clinical trial, transurethral plasmakinetic enucleation of prostate, transurethral resection of prostate
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 294 participants (estimated)
- Lead sponsor
- Zhujiang HospitalUniversity, hospital or other
- Collaborators
- Nanfang Hospital, Southern Medical University, The First Affiliated Hospital of Anhui Medical University, The First Affiliated Hospital of Nanchang University, Fourth Affiliated Hospital of Guangxi Medical University, First Affiliated Hospital of Fujian Medical University
- Study start
- 11 Oct 2017 (actual)
- Primary completion
- 6 Jun 2020 (estimated)
- Study completion
- 1 Jun 2021 (estimated)
- First posted
- 17 May 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TUKEP(enucleation of prostate) | Active comparator | Procedure: Transurethral plasmakinetic enucleation of prostatePatients 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. |
| TURP(resection of prostate) | Active comparator | Procedure: transurethral resection of prostatePatients 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. |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (8 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transurethral plasmakinetic enucleation of prostateAlso: TUKEPTransurethral 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. | Procedure or surgery | TUKEP(enucleation of prostate) |
| transurethral resection of prostateAlso: TURPTransurethral 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. | Procedure or surgery | TURP(resection of prostate) |
Primary outcome
Qmax(Maximum urinary flow rate)
Time frame: 4 years
Maximum urinary flow rate was measured at 1, 3, 6, 12, 24, 36 and 48-month postoperatively
IPSS (International Prostate Symptom Score )
Time frame: 4 years
International Prostate Symptom Score was measured at 1, 3, 6, 12, 24, 36 and 48-month postoperatively
13 secondary outcomes
QOL(Quality of Life)
Time frame: 4 years
International Index Of Erectile Function (IIEF-5)
Time frame: 4 years
Operation time
Time frame: up to 24 hours
Postoperative hospital stay
Time frame: 1 month
Indwelling catheter time
Time frame: 1 month
Postoperative irrigation
Time frame: 1 month
Decrease in Haemoglobin in 24 hours post-operation
Time frame: 1 month
Retreatment rate
Time frame: 4 years
Prostate-specific antigen(PSA)
Time frame: 4 years
Hospitalization expenses
Time frame: 1 month
Prostate volume
Time frame: 4 years
Residual urine volume
Time frame: 4 years
Claviendindo classification
Time frame: 4 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transurethral plasmakinetic enucleation of prostate and transurethral resection of prostate in people with Benign Prostatic Hyperplasia, run by Zhujiang Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Shaobo Zheng, M.D (13602888356, 1h1h1h864@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Qmax(Maximum urinary flow rate) (time frame: 4 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Mar 2020.