Lower Urinary Tract SymptomsPhase 2NCT00877669
Efficacy Study of HoLEP and TURP on LUTS Secondary to BPH
A Phase 2 study testing Transurethral resection of the prostate and Holmium Laser Enucleation of the Prostate in people with Lower Urinary Tract Symptoms and Benign Prostatic Hyperplasia, run by Samsung Medical Center at 1 site in South Korea.
Trial summary
The purpose of this study is to compare of Efficacy and Safety Between Holmium Laser Enucleation of the Prostate (HoLEP) and Transurethral Resection of the Prostate (TURP) on the Lower Urinary Tract Symptoms (LUTS) Secondary to Benign Prostate Hyperplasia (BPH). Read more about this study
- Who is it for?
- Ages 50 to 80 years, men only
- Conditions the study is for
- Lower Urinary Tract Symptoms, Benign Prostatic Hyperplasia
- What is being tested?
- Transurethral resection of the prostate and Holmium Laser Enucleation of the Prostate
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 313 participants
- Where
- 1 siteSouth Korea
- Study dates
- Oct 2008to Dec 2016
- Phase
- Phase 2
- 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
- 50 yrs or greater
- International prostatic symptom score >= 12
- Bladder outlet obstruction confirmed by pressure-flow study (BOOI > 20)
- Able to give fully informed consent
Who cannot join
- Patients with urologic malignancies such as prostate cancer and bladder cancer
- Patients underwent urethral, prostate surgery
- Patients with urethral stricture or bladder diverticulum or bladder neck contracture
- Patients with histories of bacterial prostatitis within 1 year
- seems not to be appropriate to this study by the decision of investigators because of any other reasons
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Comparison of Efficacy Between Holmium Laser Enucleation of the Prostate (HoLEP) and Transurethral Resection of the Prostate (TURP) on the Lower Urinary Tract Symptoms (LUTS) Secondary to Benign Prostate Hyperplasia (BPH)
The purpose of this study is to compare of Efficacy and Safety Between Holmium Laser Enucleation of the Prostate (HoLEP) and Transurethral Resection of the Prostate (TURP) on the Lower Urinary Tract Symptoms (LUTS) Secondary to Benign Prostate Hyperplasia (BPH).
- Being tested
- Transurethral resection of the prostate, Holmium Laser Enucleation of the Prostate
- Medical subject headings
- Lower Urinary Tract Symptoms, Prostatic Hyperplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transurethral resection of the prostateProcedure or surgery
Also called TURP
Standard transurethral resection of the prostate using electrocautery loop
Holmium Laser Enucleation of the ProstateProcedure or surgery
HoLEP using 100W Ho:YAG laser
| Study group | Role | What they receive |
|---|---|---|
| Transurethral resection of the prostate | Active comparator | TURP group Receives: Procedure: Transurethral resection of the prostate |
| Holmium Laser Enucleation of Prostate | Experimental | HoLEP group Receives: Procedure: Holmium Laser Enucleation of the Prostate |
What is being measured
The primary outcome is the main question the study is designed to answer.
The changes of International Prostatic Symptom Scores (IPSS) from baseline to 6 months after operation
Measured: 6 months
Secondary outcomes (12)
The changes of Quality of Life (QoL) parameters
Measured: 6 months
The changes of IPSS and QoL parameters
Measured: 1 month and 3months after operation
The changes of Uroflowmetry (UFM) and Postvoid residual urine(PVR) parameters
Measured: 2 weeks and 3 and 6 months after operation
Postoperative hospital stay days and postoperative catheterization days
Measured: immediate postoperative period
The changes of the hemoglobin and the serum sodium
Measured: 0 and 1 day after operation
Operative time and Resected tissue weight
Measured: 0 day after operation
The changes of ICS male questionnaire (short form) parameters
Measured: 3 and 6 months after operation
The changes of international index of erectile function (IIEF)-15 parameters
Measured: 6 months after operation
The changes of Patient perception of treatment benefit questionnaire (PPTB) parameters
Measured: 3 and 6 months after operation
The changes of voiding frequencies and urgency parameters in Frequency volume chart
Measured: 3 and 6 months after operation
Ejaculation parameter
Measured: 6 months after operation
Complications
Measured: During all study periods
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2009 (estimated)
- Study startOct 2008
- Primary completionJul 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lower Urinary Tract SymptomsStudies of the same condition, open and under way.
- More trials run by Samsung Medical CenterThe 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 313 participants (actual)
Sponsor and investigators
- Lead sponsor
- Samsung Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, KYU-SUNG LEE, Samsung Medical Center
- Investigators
- Kyu-Sung Lee, Ph.D.,M.D., Principal investigator, Samsung Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00877669
- Sponsor's protocol ID
- 2008-10-038
- Status last verified
- Nov 2019
- First submitted
- 6 Apr 2009
- Last updated
- 2 Dec 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Comparison of Efficacy Between Holmium Laser Enucleation of the Prostate (HoLEP) and Transurethral Resection of the Prostate (TURP) on the Lower Urinary Tract Symptoms (LUTS) Secondary to Benign Prostate Hyperplasia (BPH)
- ClinicalTrials.gov ID
- NCT00877669
- Acronym / sponsor ID
- 2008-10-038
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 313 participants (actual)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Study start
- Oct 2008
- Primary completion
- Jul 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 8 Apr 2009 (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 purpose of this study is to compare of Efficacy and Safety Between Holmium Laser Enucleation of the Prostate (HoLEP) and Transurethral Resection of the Prostate (TURP) on the Lower Urinary Tract Symptoms (LUTS) Secondary to Benign Prostate Hyperplasia (BPH).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Transurethral resection of the prostate | Active comparator | Procedure: Transurethral resection of the prostateTURP group |
| Holmium Laser Enucleation of Prostate | Experimental | Procedure: Holmium Laser Enucleation of the ProstateHoLEP group |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 50 yrs or greater
- International prostatic symptom score >= 12
- Bladder outlet obstruction confirmed by pressure-flow study (BOOI > 20)
- Able to give fully informed consent
Key exclusion criteria (5 listed)
- Patients with urologic malignancies such as prostate cancer and bladder cancer
- Patients underwent urethral, prostate surgery
- Patients with urethral stricture or bladder diverticulum or bladder neck contracture
- Patients with histories of bacterial prostatitis within 1 year
- seems not to be appropriate to this study by the decision of investigators because of any other reasons
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 resection of the prostateAlso: TURPStandard transurethral resection of the prostate using electrocautery loop | Procedure or surgery | Transurethral resection of the prostate |
| Holmium Laser Enucleation of the ProstateHoLEP using 100W Ho:YAG laser | Procedure or surgery | Holmium Laser Enucleation of Prostate |
Primary outcome
The changes of International Prostatic Symptom Scores (IPSS) from baseline to 6 months after operation
Time frame: 6 months
12 secondary outcomes
The changes of Quality of Life (QoL) parameters
Time frame: 6 months
The changes of IPSS and QoL parameters
Time frame: 1 month and 3months after operation
The changes of Uroflowmetry (UFM) and Postvoid residual urine(PVR) parameters
Time frame: 2 weeks and 3 and 6 months after operation
Postoperative hospital stay days and postoperative catheterization days
Time frame: immediate postoperative period
The changes of the hemoglobin and the serum sodium
Time frame: 0 and 1 day after operation
Operative time and Resected tissue weight
Time frame: 0 day after operation
The changes of ICS male questionnaire (short form) parameters
Time frame: 3 and 6 months after operation
The changes of international index of erectile function (IIEF)-15 parameters
Time frame: 6 months after operation
The changes of Patient perception of treatment benefit questionnaire (PPTB) parameters
Time frame: 3 and 6 months after operation
The changes of voiding frequencies and urgency parameters in Frequency volume chart
Time frame: 3 and 6 months after operation
Ejaculation parameter
Time frame: 6 months after operation
Complications
Time frame: During all study periods
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 2 Dec 2019.
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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.
Kyu-Sung Lee, Ph.D.,M.D. principal investigator
Samsung Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Transurethral resection of the prostate and Holmium Laser Enucleation of the Prostate in people with Lower Urinary Tract Symptoms and Benign Prostatic Hyperplasia, run by Samsung Medical Center at 1 site in South Korea.
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 4 inclusion and 5 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 2 Dec 2019. 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 South Korea. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
The changes of International Prostatic Symptom Scores (IPSS) from baseline to 6 months after operation (time frame: 6 months). 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 2 Dec 2019.