Benign Prostate HyperplasiaNCT01952912
Plasmakinetic Enucleation of the Prostate and Open Prostatectomy to Treat Large Prostates
A study testing PkEP and OP in people with Benign Prostate Hyperplasia, run by Fuzhou General Hospital at 1 site in China.
Trial summary
The investigators hypothesize that Plasmakinetic Enucleation of the Prostate (PkEP) might yield functional results comparable to OP but with lower perioperative morbidity, and have equivalent long-term efficacy with OP for large prostates. Read more about this study
- Who is it for?
- Ages 50 to 70 years, men only
- Conditions the study is for
- Benign Prostate Hyperplasia
- What is being tested?
- PkEP and OP
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 1 siteChina
- Study dates
- Jan 2004to Jun 2013
- 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 70 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- •Qmax < 12 mL/s, IPSS >19
- Age between 50 and 70 years
- Prostate volume larger than 100 mL, as determined by TRUS post-void residual urine volume greater than 50 ml medical therapy failure.
Who cannot join
- •severe pulmonary disease or heart disease, coagulopathy, neurogenic bladder, bladder calculus, bladder cancer, prostate cancer, urethral stricture and previous prostate or urethral surgery
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Plasmakinetic Enucleation of the Prostate With Open Prostatectomy for the Treatment of Benign Prostatic Hypertrophy Patients With Large Prostate
The investigators hypothesize that Plasmakinetic Enucleation of the Prostate (PkEP) might yield functional results comparable to OP but with lower perioperative morbidity, and have equivalent long-term efficacy with OP for large prostates. The first objective was to demonstrate the non-inferiority of PKEP compared to OP concerning Qmax at one year postoperatively.
To explore the long-term efficacy, we compared the efficacy, safety, and morbidity of PkEP with those of OP in BPH patients with prostate glands larger than 100 g over a follow-up period of 6 years.
- Conditions
- Benign Prostate Hyperplasia
- Being tested
- PkEP, OP
- Medical subject headings
- Prostatic Hyperplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PkEPProcedure or surgery
OPProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| PkEP | Active comparator | Not described Receives: Procedure: PkEP |
| OP | Active comparator | Not described Receives: Procedure: OP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Qmax at one year postoperatively
Measured: 1 year postoperatively
Secondary outcomes (9)
Qmax at other time points after surgery
Measured: 1, 3, 6, 24, 36, 48, 60 and 72 months postoperatively
resected adenoma weight
Measured: right after the operation
operation time
Measured: during the operation
blood loss
Measured: perioperatively and on the first postoperative day
postoperative International Prostate Symptom Score
Measured: 1, 3, 6, 12, 24, 36, 48, 60 and 72 months postoperatively
duration of catheterization
Measured: after the operation
length of postoperative hospital stay
Measured: after the operation
QOL
Measured: 1, 3, 6, 12, 24, 36, 48, 60 and 72 months postoperatively
PVR
Measured: 1, 3, 6, 12, 24, 36, 48, 60 and 72 months postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2013 (estimated)
- Study startJan 2004
- Primary completionJun 2007
- Study completionJun 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Benign Prostate HyperplasiaStudies of the same condition, open and under way.
- 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
- None (open label)
- Enrolment
- 160 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fuzhou General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01952912
- Sponsor's protocol ID
- PKEP-OP
- Status last verified
- Dec 2003
- First submitted
- 25 Sep 2013
- Last updated
- 30 Sep 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Chen S, Zhu L, Cai J, Zheng Z, Ge R, Wu M, Deng Z, Zhou H, Yang S, Wu W, Liao L, Tan J. Plasmakinetic enucleation of the prostate compared with open prostatectomy for prostates larger than 100 grams: a randomized noninferiority controlled trial with long-term results at 6 years. Eur Urol. 2014 Aug;66(2):284-91. doi: 10.1016/j.eururo.2014.01.010. Epub 2014 Jan 24.
PubMed 24502959
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Plasmakinetic Enucleation of the Prostate With Open Prostatectomy for the Treatment of Benign Prostatic Hypertrophy Patients With Large Prostate
- ClinicalTrials.gov ID
- NCT01952912
- Acronym / sponsor ID
- PKEP-OP
- Conditions
- Benign Prostate Hyperplasia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 160 participants (actual)
- Lead sponsor
- Fuzhou General HospitalUniversity, hospital or other
- Study start
- Jan 2004
- Primary completion
- Jun 2007 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 30 Sep 2013 (estimated)
- 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 investigators hypothesize that Plasmakinetic Enucleation of the Prostate (PkEP) might yield functional results comparable to OP but with lower perioperative morbidity, and have equivalent long-term efficacy with OP for large prostates. The first objective was to demonstrate the non-inferiority of PKEP compared to OP concerning Qmax at one year postoperatively.
To explore the long-term efficacy, we compared the efficacy, safety, and morbidity of PkEP with those of OP in BPH patients with prostate glands larger than 100 g over a follow-up period of 6 years.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PkEP | Active comparator | Procedure: PkEP |
| OP | Active comparator | Procedure: OP |
Who may qualify
- Ages
- 50 to 70 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- •Qmax < 12 mL/s, IPSS >19
Key exclusion criteria (1 listed)
- •severe pulmonary disease or heart disease, coagulopathy, neurogenic bladder, bladder calculus, bladder cancer, prostate cancer, urethral stricture and previous prostate or urethral 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 |
|---|---|---|
| PkEP | Procedure or surgery | PkEP |
| OP | Procedure or surgery | OP |
Primary outcome
Qmax at one year postoperatively
Time frame: 1 year postoperatively
9 secondary outcomes
Qmax at other time points after surgery
Time frame: 1, 3, 6, 24, 36, 48, 60 and 72 months postoperatively
resected adenoma weight
Time frame: right after the operation
operation time
Time frame: during the operation
blood loss
Time frame: perioperatively and on the first postoperative day
postoperative International Prostate Symptom Score
Time frame: 1, 3, 6, 12, 24, 36, 48, 60 and 72 months postoperatively
duration of catheterization
Time frame: after the operation
length of postoperative hospital stay
Time frame: after the operation
QOL
Time frame: 1, 3, 6, 12, 24, 36, 48, 60 and 72 months postoperatively
PVR
Time frame: 1, 3, 6, 12, 24, 36, 48, 60 and 72 months postoperatively
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2013.
- Derived from this study: PubMed 24502959Chen S, Zhu L, Cai J, Zheng Z, Ge R, Wu M, Deng Z, Zhou H, Yang S, Wu W, Liao L, Tan J. Plasmakinetic enucleation of the prostate compared with open prostatectomy for prostates larger than 100 grams: a randomized noninferiority controlled trial with long-term results at 6 years. Eur Urol. 2014 Aug;66(2):284-91. doi: 10.1016/j.eururo.2014.01.010. Epub 2014 Jan 24.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PkEP and OP in people with Benign Prostate Hyperplasia, run by Fuzhou General 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 3 inclusion and 1 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: finished, as of the sponsor's last update on 30 Sep 2013. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Qmax at one year postoperatively (time frame: 1 year postoperatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01952912, which also lists 1 linked publication.
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 30 Sep 2013.