BPH (Benign Prostatic Hyperplasia)Phase 4NCT02072499
KTP Green Light Prostatectomy Compared With Open Prostatectomy
A Phase 4 study testing KTP Green Light Prostatectomy, Green Light and Open prostatectomy in people with BPH (Benign Prostatic Hyperplasia), run by University of Helsinki at 1 site in Finland.
Trial summary
The purpose of this study is to compare safety and efficacy of Green Light PVP (Photoselective Vaporisation of the Prostate) compared to open prostatectomy when treating benign prostatic hyperplasia (BPH). Read more about this study
- Who is it for?
- Ages 40 to 95 years, men only
- Conditions the study is for
- BPH (Benign Prostatic Hyperplasia)
- What is being tested?
- KTP Green Light Prostatectomy, Green Light and Open prostatectomy
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteFinland
- Study dates
- Sep 2011to Oct 2017
- Phase
- Phase 4
- 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 40 to 95 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men undergoing surgery for BPH with prostate size more than 100cc
Who cannot join
- Previous prostate surgery
- Carcinoma of the prostate
- Neurogenic bladder
- Bladder carcinoma
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of KTP (Potassium-titanyl-phosphate) Green Light Prostatectomy (180W) Compared With Open Prostatectomy When Treating Benign Prostatic Hyperplasia, a Prospective Randomized Study
The purpose of this study is to compare safety and efficacy of Green Light PVP (Photoselective Vaporisation of the Prostate) compared to open prostatectomy when treating benign prostatic hyperplasia (BPH).
- Conditions
- BPH (Benign Prostatic Hyperplasia)
- Being tested
- KTP Green Light Prostatectomy, Green Light, Open prostatectomy
- Medical subject headings
- Prostatic Hyperplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KTP Green Light ProstatectomyProcedure or surgery
Green LightDevice
Open prostatectomyProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| KTP Green Light Prostatectomy | Experimental | Device Receives: Procedure: KTP Green Light Prostatectomy; Device: Green Light |
| Open prostatectomy | Active comparator | Surgical procedure Receives: Procedure: Open prostatectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
IPSS (International Prostate Symptom Score)
symptom score
Measured: 12 months
Secondary outcomes (10)
DAN-PSS (Danish Prostate Symptom Score)
symptom score
Measured: 0, 3, 6 and 12 months
Maximum flow rate (Qmax)
Measured: 0, 3, 6 and 12 months
Residual urine
Measured: 0, 3, 6 and 12 months
Length of catheterization
Measured: Participants will be followed for the duration of hospital stay, an expected maximum of two weeks
Length of hospital stay
Measured: Participants will be followed for the duration of hospital stay, an expected maximum of two weeks
Perioperative bleeding
Measured: Time of operation
IIEF (International Index of Erectile Function questionnaire)
Measured: 0,12 months
Prostate volume measured with TRUS (transrectal ultrasound)
Measured: 0, 12 moths
Rate of unscheduled hospital contacts
Measured: 12 months
IPSS (International Prostate Symptom Score)
Measured: 0, 3 and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2014 (estimated)
- Study startSep 2011
- Primary completionJun 2017
- Study completionOct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BPH (Benign Prostatic Hyperplasia)Studies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Helsinki
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hannu Koistinen, University of Helsinki
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02072499
- Sponsor's protocol ID
- 164/13/03/02/08
- Status last verified
- Nov 2017
- First submitted
- 17 Dec 2013
- Last updated
- 14 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of KTP (Potassium-titanyl-phosphate) Green Light Prostatectomy (180W) Compared With Open Prostatectomy When Treating Benign Prostatic Hyperplasia, a Prospective Randomized Study
- ClinicalTrials.gov ID
- NCT02072499
- Acronym / sponsor ID
- 164/13/03/02/08
- Conditions
- BPH (Benign Prostatic Hyperplasia)
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of HelsinkiUniversity, hospital or other
- Study start
- Sep 2011
- Primary completion
- Jun 2017 (actual)
- Study completion
- Oct 2017 (actual)
- First posted
- 26 Feb 2014 (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 safety and efficacy of Green Light PVP (Photoselective Vaporisation of the Prostate) compared to open prostatectomy when treating benign prostatic hyperplasia (BPH).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| KTP Green Light Prostatectomy | Experimental | Procedure: KTP Green Light Prostatectomy, Device: Green LightDevice |
| Open prostatectomy | Active comparator | Procedure: Open prostatectomySurgical procedure |
Who may qualify
- Ages
- 40 to 95 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Men undergoing surgery for BPH with prostate size more than 100cc
Key exclusion criteria (4 listed)
- Previous prostate surgery
- Carcinoma of the prostate
- Neurogenic bladder
- Bladder carcinoma
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 |
|---|---|---|
| KTP Green Light Prostatectomy | Procedure or surgery | KTP Green Light Prostatectomy |
| Green Light | Device | KTP Green Light Prostatectomy |
| Open prostatectomy | Procedure or surgery | Open prostatectomy |
Primary outcome
IPSS (International Prostate Symptom Score)
Time frame: 12 months
symptom score
10 secondary outcomes
DAN-PSS (Danish Prostate Symptom Score)
Time frame: 0, 3, 6 and 12 months
Maximum flow rate (Qmax)
Time frame: 0, 3, 6 and 12 months
Residual urine
Time frame: 0, 3, 6 and 12 months
Length of catheterization
Time frame: Participants will be followed for the duration of hospital stay, an expected maximum of two weeks
Length of hospital stay
Time frame: Participants will be followed for the duration of hospital stay, an expected maximum of two weeks
Perioperative bleeding
Time frame: Time of operation
IIEF (International Index of Erectile Function questionnaire)
Time frame: 0,12 months
Prostate volume measured with TRUS (transrectal ultrasound)
Time frame: 0, 12 moths
Rate of unscheduled hospital contacts
Time frame: 12 months
IPSS (International Prostate Symptom Score)
Time frame: 0, 3 and 6 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 14 Nov 2017.
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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 Phase 4 study testing KTP Green Light Prostatectomy, Green Light and Open prostatectomy in people with BPH (Benign Prostatic Hyperplasia), run by University of Helsinki at 1 site in Finland.
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 1 inclusion and 4 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 14 Nov 2017. 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 Finland. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
IPSS (International Prostate Symptom Score) (time frame: 12 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 14 Nov 2017.