BPH With Large ProstateNCT01637701
Plasmakinetic Enucleation of the Prostate to Treat Benign Prostatic Hypertrophy Patients With Large Prostate
A study testing PkEP and B-TURP in people with BPH With Large Prostate, run by Fuzhou General Hospital at 1 site in China.
Trial summary
The goal of this study is to compare the perioperative and postoperative characters of plasmakinetic enucleation of the prostate(PkEP) with bipolar TURP(B-TURP) for BPH patients with large prostate. Read more about this study
- Who is it for?
- Ages 50 to 70 years, men only
- Conditions the study is for
- BPH With Large Prostate
- What is being tested?
- PkEP and B-TURP
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteChina
- Study dates
- Jun 2004to Dec 2011
- 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 < 10 mL/s, IPSS >19
- Age between 50 and 70 years
- Prostate volume between 70 and 200 mL, as determined by TRUS, and medical therapy failure.
Who cannot join
- Patients with neurogenic bladder
- Urethral stricture
- Bladder tumor
- Prostate cancer and previous prostate bladder neck
- Urethral surgery
- PSA>4ng/ml, or receiving prostate biopsy within 3 months
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Pasmakinetic Enucleation of the Prostate With Bipolar Transurethral Resection of the Prostate for the Treatment of Benign Prostatic Hypertrophy Patients With Large Prostate
The goal of this study is to compare the perioperative and postoperative characters of plasmakinetic enucleation of the prostate(PkEP) with bipolar TURP(B-TURP) for BPH patients with large prostate.
Read the detailed description
Despite the availability of numerous minimally invasive alternatives, monopolar transurethral resection of the prostate (TURP) remains the most frequently performed operation for benign prostatic hypertrophy (BPH) with small to moderate size prostates. Nevertheless, TURP for large prostates is associated with various complications and unsatisfactory long-term results. B-TURP and PkEP have both been proved to have more favorable postoperative outcomes than monopolar TURP. But whether B-TURP or PkEP is better remain controversial. We aim to compare the perioperative and postoperative characters of PkEP with B-TURP for BPH patients with large prostate. Moreover, we evaluate the long-term results of both approaches.
- Conditions
- BPH With Large Prostate
- Being tested
- PkEP, B-TURP
- Keywords
- benign prostatic hypertrophy, bipolar transurethral resection of the prostate, plasmakinetic enucleation of the 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.
PkEPProcedure or surgery
Plasmakinetic enucleation of the prostate
B-TURPProcedure or surgery
Bipolar transurethral resection of the prostate
| Study group | Role | What they receive |
|---|---|---|
| PkEP | Active comparator | Patients in this group undergo PkEP using the Gyrus plasmakinetic tissue management system (Gyrus Medical Ltd,Bucks,UK). Receives: Procedure: PkEP |
| B-TURP | Active comparator | Patients in this group undergo B-TURP using the Gyrus plasmakinetic tissue management system (Gyrus Medical Ltd,Bucks,UK). Receives: Procedure: B-TURP |
What is being measured
The primary outcome is the main question the study is designed to answer.
time of catheterization
At the end of both procedures, a 22F three-way Folley catheter was inserted and continuous bladder irrigation was performed. Irrigation was discontinued when the catheter drainage became clear, and the catheter was removed 6 h later.Two experienced urologists who were unaware of the surgical modality used decided bladder irrigation and catheter removal for all cases.
Secondary outcomes (6)
Operation time
resected adenoma weight as a measure of treatment efficacy
changes in serum haemoglobin as a measure of one of the complications
postoperative International Prostate Symptom Score as a measure of treatment efficacy and durability
Measured: 5 years
postoperative Qmax as a masure of treatment efficacy and durability
Measured: 5 years
re-operation rate as a measure of durability
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2012 (estimated)
- Study startJun 2004
- Primary completionDec 2006
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BPH With Large ProstateStudies 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
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fuzhou General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jianming Tan, M.D. & Ph.D., Study director, Fuzhou General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01637701
- Sponsor's protocol ID
- PkEP-TURP-2004
- Status last verified
- Jul 2012
- First submitted
- 4 Jul 2012
- Last updated
- 11 Jul 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Pasmakinetic Enucleation of the Prostate With Bipolar Transurethral Resection of the Prostate for the Treatment of Benign Prostatic Hypertrophy Patients With Large Prostate
- ClinicalTrials.gov ID
- NCT01637701
- Acronym / sponsor ID
- PkEP-TURP-2004
- Conditions
- BPH With Large Prostate
- Keywords
- benign prostatic hypertrophy, bipolar transurethral resection of the prostate, plasmakinetic enucleation of the prostate
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Fuzhou General HospitalUniversity, hospital or other
- Study start
- Jun 2004
- Primary completion
- Dec 2006 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 11 Jul 2012 (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 goal of this study is to compare the perioperative and postoperative characters of plasmakinetic enucleation of the prostate(PkEP) with bipolar TURP(B-TURP) for BPH patients with large prostate.
Detailed description
Despite the availability of numerous minimally invasive alternatives, monopolar transurethral resection of the prostate (TURP) remains the most frequently performed operation for benign prostatic hypertrophy (BPH) with small to moderate size prostates. Nevertheless, TURP for large prostates is associated with various complications and unsatisfactory long-term results. B-TURP and PkEP have both been proved to have more favorable postoperative outcomes than monopolar TURP. But whether B-TURP or PkEP is better remain controversial. We aim to compare the perioperative and postoperative characters of PkEP with B-TURP for BPH patients with large prostate. Moreover, we evaluate the long-term results of both approaches.
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: PkEPPatients in this group undergo PkEP using the Gyrus plasmakinetic tissue management system (Gyrus Medical Ltd,Bucks,UK). |
| B-TURP | Active comparator | Procedure: B-TURPPatients in this group undergo B-TURP using the Gyrus plasmakinetic tissue management system (Gyrus Medical Ltd,Bucks,UK). |
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 < 10 mL/s, IPSS >19
- Age between 50 and 70 years
- Prostate volume between 70 and 200 mL, as determined by TRUS, and medical therapy failure.
Key exclusion criteria (6 listed)
- Patients with neurogenic bladder
- Urethral stricture
- Bladder tumor
- Prostate cancer and previous prostate bladder neck
- 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 |
|---|---|---|
| PkEPPlasmakinetic enucleation of the prostate | Procedure or surgery | PkEP |
| B-TURPBipolar transurethral resection of the prostate | Procedure or surgery | B-TURP |
Primary outcome
time of catheterization
At the end of both procedures, a 22F three-way Folley catheter was inserted and continuous bladder irrigation was performed. Irrigation was discontinued when the catheter drainage became clear, and the catheter was removed 6 h later.Two experienced urologists who were unaware of the surgical modality used decided bladder irrigation and catheter removal for all cases.
6 secondary outcomes
Operation time
resected adenoma weight as a measure of treatment efficacy
changes in serum haemoglobin as a measure of one of the complications
postoperative International Prostate Symptom Score as a measure of treatment efficacy and durability
Time frame: 5 years
postoperative Qmax as a masure of treatment efficacy and durability
Time frame: 5 years
re-operation rate as a measure of durability
Time frame: 5 years
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 11 Jul 2012.
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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.
Jianming Tan, M.D. & Ph.D. study director
Fuzhou General Hospital
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 B-TURP in people with BPH With Large Prostate, 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 6 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 11 Jul 2012. 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?
time of catheterization. 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 11 Jul 2012.