Lower Urinary Tract SymptomsNCT00908427
Impact of 80 W KTP Laser Vaporization Prostatectomy on Severity of Obstruction in Benign Prostatic Hyperplasia
A study testing photoselective vaporization prostatectomy (PVP) and Transurethral resection 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 compared the efficacy of 80W KTP photoselective laser vaporization prostatectomy (PVP) and transurethral resection of the prostate (TURP) in reducing the volume of prostate and relieving the obstruction in men with benign prostatic hyperplasia (BPH) on non-randomized controlled design. Read more about this study
- Who is it for?
- Ages 50 years and older, men only
- Conditions the study is for
- Lower Urinary Tract Symptoms, Benign Prostatic Hyperplasia
- What is being tested?
- photoselective vaporization prostatectomy (PVP) and Transurethral resection of the prostate
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 86 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jun 2004to Sep 2007
- 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 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Symptomatic BPH
- International Score Prostate Symptom (IPSS) of 13 or greater
- prostate volume of 30 to 100 ML
- Peak urinary flow rate (Qmax) less than 15 mL/s with a voided volume of >125 mL and a PVR <350mL
- Able to give fully informed consent
Who cannot join
- Subjects with histological diagnosis of prostate cancer
- Subjects with history of chronic urinary retention
- Subjects with urethral stricture,
- Subjects with bladder neck contracture
- Subjects with urinary tract infection
- Subjects with prostate volume on TRUS of >100 mL
- Subjects with suspected neurogenic bladder dysfunction
- Subjects who, in the opinion of investigator, are not likely to complete the study for whatever reason
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of 80 Watt KTP Photoselective Laser Vaporization Prostatectomy on Severity of Obstruction in Benign Prostatic Hyperplasia: 6-Month Results of a Nonrandomized Prospective Trial
The purpose of this study is to compared the efficacy of 80W KTP photoselective laser vaporization prostatectomy (PVP) and transurethral resection of the prostate (TURP) in reducing the volume of prostate and relieving the obstruction in men with benign prostatic hyperplasia (BPH) on non-randomized controlled design.
- Being tested
- photoselective vaporization prostatectomy (PVP), Transurethral resection of the prostate
- Keywords
- benign prostatic hyperplasia, KTP laser, transurethral resection of prostate, urinary bladder neck obstruction
- Medical subject headings
- Lower Urinary Tract Symptoms, Prostatic Hyperplasia, Urinary Bladder Neck Obstruction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
photoselective vaporization prostatectomy (PVP)Procedure or surgery
Also called PVP
PVP using 80 W KTP laser with a Greenlight system (GreenLight PVTM, Laserscope®, San Jose, CA)
Transurethral resection of the prostateProcedure or surgery
Also called TURP
Standard transurethral resection of the prostate using electrocautery loop
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | PVP group Receives: Procedure: photoselective vaporization prostatectomy (PVP) |
| 2 | Active comparator | TURP group Receives: Procedure: Transurethral resection of the prostate |
What is being measured
The primary outcome is the main question the study is designed to answer.
The changes of bladder outlet obstruction index (BOOI)
Measured: 6months
Secondary outcomes (10)
The changes of Quality of Life (QoL) parameters
Measured: 6, 12 months
The changes of Uroflowmetry (UFM) and Postvoid residual urine(PVR)
Measured: 6, 12 months
The changes of detrusor pressure at maximum flow rate (PdetQmax)parameters
Measured: 6months
The changes of International Prostatic Symptom Scores (IPSS)
Measured: 6, 12 months
The changes of Schafer obstruction grade parameters
Measured: 6months
The changes of prostate volume
Measured: 6, 12 months
postoperative catheterization days
Measured: immediate postoperative period
Complications
Measured: During all study periods
The changes of the hemoglobin and the serum sodium and the serum PSA
Measured: immediate postoperative period
The change of IIEF score
Measured: 6, 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2009 (estimated)
- Study startJun 2004
- Primary completionMay 2006
- Study completionSep 2007
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 N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 86 participants (actual)
Sponsor and investigators
- Lead sponsor
- Samsung Medical Center
- Sponsor type
- University, hospital or other
- Investigators
- Sung-Won Lee, Ph.D.,M.D., Principal investigator, Samsung Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00908427
- Sponsor's protocol ID
- 2004-05-09
- Status last verified
- May 2009
- First submitted
- 22 May 2009
- Last updated
- 25 May 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of 80 Watt KTP Photoselective Laser Vaporization Prostatectomy on Severity of Obstruction in Benign Prostatic Hyperplasia: 6-Month Results of a Nonrandomized Prospective Trial
- ClinicalTrials.gov ID
- NCT00908427
- Acronym / sponsor ID
- 2004-05-09
- Keywords
- benign prostatic hyperplasia, KTP laser, transurethral resection of prostate, urinary bladder neck obstruction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 86 participants (actual)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Study start
- Jun 2004
- Primary completion
- May 2006 (actual)
- Study completion
- Sep 2007 (actual)
- First posted
- 25 May 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 compared the efficacy of 80W KTP photoselective laser vaporization prostatectomy (PVP) and transurethral resection of the prostate (TURP) in reducing the volume of prostate and relieving the obstruction in men with benign prostatic hyperplasia (BPH) on non-randomized controlled design.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Procedure: photoselective vaporization prostatectomy (PVP)PVP group |
| 2 | Active comparator | Procedure: Transurethral resection of the prostateTURP group |
Who may qualify
- Ages
- 50 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Symptomatic BPH
- International Score Prostate Symptom (IPSS) of 13 or greater
- prostate volume of 30 to 100 ML
- Peak urinary flow rate (Qmax) less than 15 mL/s with a voided volume of >125 mL and a PVR <350mL
- Able to give fully informed consent
Key exclusion criteria (8 listed)
- Subjects with histological diagnosis of prostate cancer
- Subjects with history of chronic urinary retention
- Subjects with urethral stricture,
- Subjects with bladder neck contracture
- Subjects with urinary tract infection
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 |
|---|---|---|
| photoselective vaporization prostatectomy (PVP)Also: PVPPVP using 80 W KTP laser with a Greenlight system (GreenLight PVTM, Laserscope®, San Jose, CA) | Procedure or surgery | 1 |
| Transurethral resection of the prostateAlso: TURPStandard transurethral resection of the prostate using electrocautery loop | Procedure or surgery | 2 |
Primary outcome
The changes of bladder outlet obstruction index (BOOI)
Time frame: 6months
10 secondary outcomes
The changes of Quality of Life (QoL) parameters
Time frame: 6, 12 months
The changes of Uroflowmetry (UFM) and Postvoid residual urine(PVR)
Time frame: 6, 12 months
The changes of detrusor pressure at maximum flow rate (PdetQmax)parameters
Time frame: 6months
The changes of International Prostatic Symptom Scores (IPSS)
Time frame: 6, 12 months
The changes of Schafer obstruction grade parameters
Time frame: 6months
The changes of prostate volume
Time frame: 6, 12 months
postoperative catheterization days
Time frame: immediate postoperative period
Complications
Time frame: During all study periods
The changes of the hemoglobin and the serum sodium and the serum PSA
Time frame: immediate postoperative period
The change of IIEF score
Time frame: 6, 12 months
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 25 May 2009.
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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.
Sung-Won 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 study testing photoselective vaporization prostatectomy (PVP) and Transurethral resection 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 5 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: finished, as of the sponsor's last update on 25 May 2009. 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.
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 bladder outlet obstruction index (BOOI) (time frame: 6months). 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 25 May 2009.