BPH (Benign Prostatic Hyperplasia)NCT02075736
KTP Green Light Prostatectomy Compared With TUR-P in High Risk Patients
A study testing KTP laser and TUR-P 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 Vaporization of the Prostate) compared to TUR-P in high risk patients Read more about this study
- Who is it for?
- Ages 40 to 90 years, men only
- Conditions the study is for
- BPH (Benign Prostatic Hyperplasia)
- What is being tested?
- KTP laser and TUR-P
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteFinland
- Study dates
- Mar 2011to 31 Dec 2025
- 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 40 to 90 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men with anticoagulant medication undergoing surgery for BPH
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 (120W) Compared With TUR-P When Treating Benign Prostatic Hyperplasia in High Risk Patients, A Prospective Randomized Study
The purpose of this study is to compare safety and efficacy of Green Light PVP (Photoselective Vaporization of the Prostate) compared to TUR-P in high risk patients
- Conditions
- BPH (Benign Prostatic Hyperplasia)
- Being tested
- KTP laser, TUR-P
- 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 laserProcedure or surgery
Also called Green laser
TUR-PProcedure or surgery
device
| Study group | Role | What they receive |
|---|---|---|
| KTP laser | Experimental | device Receives: Procedure: KTP laser |
| TUR-P | Active comparator | device Receives: Procedure: TUR-P |
What is being measured
The primary outcome is the main question the study is designed to answer.
Re-bleeding rate requiring hospitalization
Measured: two months postoperatively
Secondary outcomes (9)
IPSS (International Prostate Symptom Score)
symptom score
Measured: 0, 3, 6 and 12 months
DAN-PSS (Danish Prostate 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 one week
Length of hospital stay
Measured: Participants will be followed for the duration of hospital stay, an expected maximum of one week
Perioperative bleeding
Measured: Time of operation
IIEF (International Index of Erectile Function) questionnaire
Measured: 0,12 months
TRUS (transrectal ultrasound)
Measured: 0, 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2014 (estimated)
- Study startMar 2011
- Primary completion31 Aug 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
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
- NCT02075736
- Sponsor's protocol ID
- 35/13/03/02/08
- Status last verified
- Mar 2024
- First submitted
- 24 Feb 2014
- Last updated
- 6 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2024. 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 (120W) Compared With TUR-P When Treating Benign Prostatic Hyperplasia in High Risk Patients, A Prospective Randomized Study
- ClinicalTrials.gov ID
- NCT02075736
- Acronym / sponsor ID
- 35/13/03/02/08
- Conditions
- BPH (Benign Prostatic Hyperplasia)
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University of HelsinkiUniversity, hospital or other
- Study start
- Mar 2011
- Primary completion
- 31 Aug 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 3 Mar 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 Vaporization of the Prostate) compared to TUR-P in high risk patients
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| KTP laser | Experimental | Procedure: KTP laserdevice |
| TUR-P | Active comparator | Procedure: TUR-Pdevice |
Who may qualify
- Ages
- 40 to 90 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Men with anticoagulant medication undergoing surgery for BPH
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 laserAlso: Green laser | Procedure or surgery | KTP laser |
| TUR-Pdevice | Procedure or surgery | TUR-P |
Primary outcome
Re-bleeding rate requiring hospitalization
Time frame: two months postoperatively
9 secondary outcomes
IPSS (International Prostate Symptom Score)
Time frame: 0, 3, 6 and 12 months
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 one week
Length of hospital stay
Time frame: Participants will be followed for the duration of hospital stay, an expected maximum of one week
Perioperative bleeding
Time frame: Time of operation
IIEF (International Index of Erectile Function) questionnaire
Time frame: 0,12 months
TRUS (transrectal ultrasound)
Time frame: 0, 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2024.
Related trials for BPH (Benign Prostatic Hyperplasia)
Active, not recruitingPhase 1/2
RT-310 Safety and Feasibility BPH Study
BPH (Benign Prostatic Hyperplasia)
RecruitingPhase 2
Surface Electrical Stimulation for Urinary Incontinence in Men Treated for Prostate Cancer
Urinary Urge Incontinence, Stress Urinary Incontinence
Not yet recruiting
Prostatic Artery Embolization Using Histoacryl as a Novel Embolizing Agent for Treatment of BPH
Benign Prostatic Hyperplasia, Lower Urinary Tract Symptoms
Recruiting
Evaluation of the Aulea Veloxion™ Disposable Resectoscope System for Operational Efficiency in Surgical Management of Benign Prostatic Hyperplasia (BPH)
BPH (Benign Prostatic Hyperplasia)
Recruiting
Comparing Rezum and Urolift
Benign Prostatic Hyperplasia
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 KTP laser and TUR-P 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: status not confirmed, as of the sponsor's last update on 6 Mar 2024. 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.
Are results available for this study?
Results are not available in the source record.
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?
Re-bleeding rate requiring hospitalization (time frame: two months postoperatively). 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 6 Mar 2024.