Benign Prostatic HyperplasiaPhase 4NCT02283684
GreenLight Laser Photoselective Vaporization of the Prostate vs Bipolar Transurethral Vaporization of the Prostate; RCT
A Phase 4 study testing Greenlight laser PVP and Bipolar TUVP in people with Benign Prostatic Hyperplasia, run by Mansoura University at 1 site in Egypt.
Trial summary
With a growing body of knowledge on the promising advancements and recent clinical data of the third generations of the Greenlight PVP/XPS, it seems to be a real contender in the world of MIS. Contenders of Greenlight laser technology includes bipolar as well as Holmium laser technology. Read more about this study
- Who is it for?
- Ages 50 years and older, men only
- Conditions the study is for
- Benign Prostatic Hyperplasia
- What is being tested?
- Greenlight laser PVP and Bipolar TUVP
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteEgypt
- Study dates
- Sep 2014to Feb 2018
- 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 50 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients' age ≥50 years
- LUTS secondary to BOO due to BPH who failed medical treatment
- International prostate symptom scores (IPSS) >15 and bother score (QOL) ≥ 3 (according to IPSS question 8)
- Peak urinary flow rate (Qmax) <15 ml/sec with at least 125 ml voided volume or Patients with acute urine retention secondary to BPH who failed trial of voiding on medical treatment.
- ASA (American society of anaesthesiologists) score ≤3.
- TRUS prostate size (from 30 to 80ml)
Who cannot join
- Patient with neurological disorder which might affect bladder function as cerebrovascular stroke, Parkinson disease
- Active urinary tract infection,
- Presence of active bladder cancer (within the last 2 years)
- Known prostate cancer patients will be excluded preoperatively on the basis of digital rectal examination, prostate specific antigen level, and TRUS imaging followed by prostate biopsies if necessary.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Green Light Laser (XPS) Photoselective Vaporization of the Prostate (PVP) Versus Bipolar Transurethral Vaporization (B.TUVP) of the Prostate for Treatment of Small to Moderate Sized Benign Prostate Hyperplasia: A Randomized Study
With a growing body of knowledge on the promising advancements and recent clinical data of the third generations of the Greenlight PVP/XPS, it seems to be a real contender in the world of MIS. Contenders of Greenlight laser technology includes bipolar as well as Holmium laser technology.
In this study the investigators planned to test the Greenlight (532-nm) laser PVP using (XPS) 180W system compared to bipolar electro-vaporization, in reduction of LUTS secondary to small to moderate sized BPH in a prospective randomized trial.
Read the detailed description
Patients with LUTS due to BPH seen through the outpatient prostate clinic in the Mansoura UNC were assessed to evaluate if the patient is eligible to the study inclusion criteria. Patients who are meeting these criteria were asked to participate in this randomized comparative study and were provided with an informed consent form. Study participants were enrolled and randomized, and the appropriate scheduled procedures were performed.
Preoperatively, all patients were thoroughly evaluated by medical history and physical exam, digital rectal exam (DRE), prostate specific antigen (PSA), urinalysis and urine culture, international index of prostate symptom score (IPSS), Quality of Life (QOL), transrectal ultrasound (TRUS) measurement of prostatic volume and biopsy whenever indicated, measurement of post-void residual assessment (PVR), and maximum urinary flow rate (Qmax). Preoperative flexible urethrocystoscopy was done when hematuria was the presenting symptom.
- Conditions
- Benign Prostatic Hyperplasia
- Being tested
- Greenlight laser PVP, Bipolar TUVP
- Keywords
- LASER, PROSTATE, BIPOLAR, HYPERPLASIA, VAPORIZATION
- Medical subject headings
- Prostatic Hyperplasia, Hyperplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Greenlight laser PVPProcedure or surgery
Also called Greenlight (532-nm) laser PVP using (XPS) 180W system
Vaporization of the prostate adenoma using 532nm laser with 180W XPS system using Moxy fiber
Bipolar TUVPProcedure or surgery
Bipolar energy is used for generation of plasma that ends up by vaporization of the prostate adenoma
| Study group | Role | What they receive |
|---|---|---|
| Greenlight laser PVP | Active comparator | Greenlight (532-nm) laser Photoselective vaporization of the prostate using (XPS) 180W system Receives: Procedure: Greenlight laser PVP |
| Bipolar TUVP | Active comparator | Bipolar transurethral vaporization of the prostate using bipolar system Receives: Procedure: Bipolar TUVP |
What is being measured
The primary outcome is the main question the study is designed to answer.
IPSS change
change in the symptoms score over two years post procedure
Measured: two years
Secondary outcomes (3)
Reoperation rate
need for reintervention post procedure
Measured: 4 years
Q.max
maximal urine flow rate
Measured: 2 years
biopsy
clinicopathological outcome
Measured: one month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2014 (estimated)
- Study startSep 2014
- Primary completionNov 2015
- Study completionFeb 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Benign Prostatic HyperplasiaStudies of the same condition, open and under way.
- More trials run by Mansoura UniversityThe 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Elshal, Mansoura University
- Investigators
- Ahmed M Elshal, MD, Principal investigator, Mansoura University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02283684
- Sponsor's protocol ID
- Mans-2014-03
- Status last verified
- Jun 2019
- First submitted
- 2 Nov 2014
- Last updated
- 12 Jun 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Green Light Laser (XPS) Photoselective Vaporization of the Prostate (PVP) Versus Bipolar Transurethral Vaporization (B.TUVP) of the Prostate for Treatment of Small to Moderate Sized Benign Prostate Hyperplasia: A Randomized Study
- ClinicalTrials.gov ID
- NCT02283684
- Acronym / sponsor ID
- Mans-2014-03
- Conditions
- Benign Prostatic Hyperplasia
- Keywords
- LASER, PROSTATE, BIPOLAR, HYPERPLASIA, VAPORIZATION
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- Sep 2014
- Primary completion
- Nov 2015 (actual)
- Study completion
- Feb 2018 (actual)
- First posted
- 5 Nov 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.
With a growing body of knowledge on the promising advancements and recent clinical data of the third generations of the Greenlight PVP/XPS, it seems to be a real contender in the world of MIS. Contenders of Greenlight laser technology includes bipolar as well as Holmium laser technology.
In this study the investigators planned to test the Greenlight (532-nm) laser PVP using (XPS) 180W system compared to bipolar electro-vaporization, in reduction of LUTS secondary to small to moderate sized BPH in a prospective randomized trial.
Detailed description
Patients with LUTS due to BPH seen through the outpatient prostate clinic in the Mansoura UNC were assessed to evaluate if the patient is eligible to the study inclusion criteria. Patients who are meeting these criteria were asked to participate in this randomized comparative study and were provided with an informed consent form. Study participants were enrolled and randomized, and the appropriate scheduled procedures were performed.
Preoperatively, all patients were thoroughly evaluated by medical history and physical exam, digital rectal exam (DRE), prostate specific antigen (PSA), urinalysis and urine culture, international index of prostate symptom score (IPSS), Quality of Life (QOL), transrectal ultrasound (TRUS) measurement of prostatic volume and biopsy whenever indicated, measurement of post-void residual assessment (PVR), and maximum urinary flow rate (Qmax). Preoperative flexible urethrocystoscopy was done when hematuria was the presenting symptom.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Greenlight laser PVP | Active comparator | Procedure: Greenlight laser PVPGreenlight (532-nm) laser Photoselective vaporization of the prostate using (XPS) 180W system |
| Bipolar TUVP | Active comparator | Procedure: Bipolar TUVPBipolar transurethral vaporization of the prostate using bipolar system |
Who may qualify
- Ages
- 50 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients' age ≥50 years
- LUTS secondary to BOO due to BPH who failed medical treatment
- International prostate symptom scores (IPSS) >15 and bother score (QOL) ≥ 3 (according to IPSS question 8)
- Peak urinary flow rate (Qmax) <15 ml/sec with at least 125 ml voided volume or Patients with acute urine retention secondary to BPH who failed trial of voiding on medical treatment.
- ASA (American society of anaesthesiologists) score ≤3.
Key exclusion criteria (4 listed)
- Patient with neurological disorder which might affect bladder function as cerebrovascular stroke, Parkinson disease
- Active urinary tract infection,
- Presence of active bladder cancer (within the last 2 years)
- Known prostate cancer patients will be excluded preoperatively on the basis of digital rectal examination, prostate specific antigen level, and TRUS imaging followed by prostate biopsies if necessary.
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 |
|---|---|---|
| Greenlight laser PVPAlso: Greenlight (532-nm) laser PVP using (XPS) 180W systemVaporization of the prostate adenoma using 532nm laser with 180W XPS system using Moxy fiber | Procedure or surgery | Greenlight laser PVP |
| Bipolar TUVPBipolar energy is used for generation of plasma that ends up by vaporization of the prostate adenoma | Procedure or surgery | Bipolar TUVP |
Primary outcome
IPSS change
Time frame: two years
change in the symptoms score over two years post procedure
3 secondary outcomes
Reoperation rate
Time frame: 4 years
Q.max
Time frame: 2 years
biopsy
Time frame: one month
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 12 Jun 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.
Ahmed M Elshal, MD principal investigator
Mansoura University
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 Greenlight laser PVP and Bipolar TUVP in people with Benign Prostatic Hyperplasia, run by Mansoura University at 1 site in Egypt.
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 6 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 12 Jun 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 Egypt. 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 change (time frame: two years). 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 12 Jun 2019.