Benign Prostate HyperplasiaNCT02332538
HoLEP vs. Greenlight 532nm-laser PVEP vs. Bipolar TURP in Management of Moderate/ Large BPH
A study testing 532nm-laser photoselective vapo-enucleation of the prostate), Holmium laser enucleation of prostate and Bipolar TURP in people with Benign Prostate Hyperplasia and Lower Urinary Tract Symptoms, run by Mansoura University at 1 site in Egypt.
Trial summary
Most guidelines are not strict for recommending single treatment approach for Moderate to large prostate. In this study the investigators planned to test the Greenlight (532-nm) laser Photoselective Vapo-Enucleation of the Prostate (PVEP) using (XPS) 180W system compared to bipolar transurethral resection of the… Read more about this study
- Who is it for?
- Ages 50 years and older, men only
- Conditions the study is for
- Benign Prostate Hyperplasia, Lower Urinary Tract Symptoms
- What is being tested?
- 532nm-laser photoselective vapo-enucleation of the prostate), Holmium laser enucleation of prostate and Bipolar TURP
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 182 participants
- Where
- 1 siteEgypt
- Study dates
- Mar 2014to Jul 2019
- 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
- Patients' age ≥50 years
- LUTS secondary to BOO due to BPH who failed medical treatment
- International prostate symptom scores 8 (IPSS) >15 and bother score 8 (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 (>/=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: Randomized Trial Comparing Holmium Laser Enucleation of the Prostate vs. Greenlight 532nm-laser Vapo-Enucleation of the Prostate vs. Bipolar Transurethral Resection of the Prostate in Management of Moderate/Large Benign Prostate Hyperplasia
Most guidelines are not strict for recommending single treatment approach for Moderate to large prostate.
In this study the investigators planned to test the Greenlight (532-nm) laser Photoselective Vapo-Enucleation of the Prostate (PVEP) using (XPS) 180W system compared to bipolar transurethral resection of the prostate (TURis) and Holmium Laser Enucleation of the Prostate (HOLEP) in reduction of lower urinary tract symptoms (LUTS) secondary to BPH in a prospective randomized trial.
Read the detailed description
With a growing body of knowledge on the promising advancements and recent clinical data of the third generations of the Greenlight 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 Photoselective Vapo-Enucleation of the Prostate (PVEP) using (XPS) 180W system compared to bipolar transurethral resection of the prostate (TURis) and Holmium Laser Enucleation of the Prostate (HOLEP) in reduction of LUTS secondary to BPH in a prospective randomized trial.
Furthermore, all peri-operative parameters, urinary flow parameters, prostate size changes and complications associated with the procedures were compared. The prostate size limitations will be assessed in relation to the outcome measures.
Moderate to large size prostate (80-120 ml TRUS estimated volume) will be randomized to PVEP vs. Bipolar TURP vs. HoLEP.
- Being tested
- 532nm-laser photoselective vapo-enucleation of the prostate), Holmium laser enucleation of prostate, Bipolar TURP
- Keywords
- LASER, PROSTATE, BIPOLAR, HYPERPLASIA, VAPORIZATION
- Medical subject headings
- Prostatic Hyperplasia, Lower Urinary Tract Symptoms, Hyperplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
532nm-laser photoselective vapo-enucleation of the prostate)Procedure or surgery
using Greenlight (532nm-laser) modified vaporization technique, PVEP (photoselective vapo-enucleation of the prostate)
Holmium laser enucleation of prostateProcedure or surgery
Holmium-Yag laser enucleation of the prsotate
Bipolar TURPProcedure or surgery
Bipolar transurethral resection of the prostate in saline
| Study group | Role | What they receive |
|---|---|---|
| Greenlight (532nm-laser) PVEP | Active comparator | 532nm-laser photoselective vapo-enucleation of the prostate) Receives: Procedure: 532nm-laser photoselective vapo-enucleation of the prostate) |
| Holmium laser enucleation of prostate | Active comparator | Holmium-Yag laser enucleation of the prostate Receives: Procedure: Holmium laser enucleation of prostate |
| Bipolar TURP | Active comparator | Bipolar transurethral resection of the prostate in saline Receives: Procedure: Bipolar TURP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Re treatment
need for retreatment for recurrent infravesical obstruction following primary surgery
Measured: 3 YEARs
Secondary outcomes (2)
change in symptoms score
degree of improvement in the lower urinary tract symptoms
Measured: 3 year
Urine Flow rate (ml/sec)
degree of improvement in the rate of urine flow
Measured: 3 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2015 (estimated)
- Study startMar 2014
- Primary completionJul 2016
- Study completionJul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Benign Prostate 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 182 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
- NCT02332538
- Sponsor's protocol ID
- MS/16.04.79
- Status last verified
- Oct 2019
- First submitted
- 27 Dec 2014
- Last updated
- 16 Oct 2019
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Trial Comparing Holmium Laser Enucleation of the Prostate vs. Greenlight 532nm-laser Vapo-Enucleation of the Prostate vs. Bipolar Transurethral Resection of the Prostate in Management of Moderate/Large Benign Prostate Hyperplasia
- ClinicalTrials.gov ID
- NCT02332538
- Acronym / sponsor ID
- MS/16.04.79
- Keywords
- LASER, PROSTATE, BIPOLAR, HYPERPLASIA, VAPORIZATION
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 182 participants (actual)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- Mar 2014 (actual)
- Primary completion
- Jul 2016 (actual)
- Study completion
- Jul 2019 (actual)
- First posted
- 7 Jan 2015 (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.
Most guidelines are not strict for recommending single treatment approach for Moderate to large prostate.
In this study the investigators planned to test the Greenlight (532-nm) laser Photoselective Vapo-Enucleation of the Prostate (PVEP) using (XPS) 180W system compared to bipolar transurethral resection of the prostate (TURis) and Holmium Laser Enucleation of the Prostate (HOLEP) in reduction of lower urinary tract symptoms (LUTS) secondary to BPH in a prospective randomized trial.
Detailed description
With a growing body of knowledge on the promising advancements and recent clinical data of the third generations of the Greenlight 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 Photoselective Vapo-Enucleation of the Prostate (PVEP) using (XPS) 180W system compared to bipolar transurethral resection of the prostate (TURis) and Holmium Laser Enucleation of the Prostate (HOLEP) in reduction of LUTS secondary to BPH in a prospective randomized trial.
Furthermore, all peri-operative parameters, urinary flow parameters, prostate size changes and complications associated with the procedures were compared. The prostate size limitations will be assessed in relation to the outcome measures.
Moderate to large size prostate (80-120 ml TRUS estimated volume) will be randomized to PVEP vs. Bipolar TURP vs. HoLEP.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Greenlight (532nm-laser) PVEP | Active comparator | Procedure: 532nm-laser photoselective vapo-enucleation of the prostate)532nm-laser photoselective vapo-enucleation of the prostate) |
| Holmium laser enucleation of prostate | Active comparator | Procedure: Holmium laser enucleation of prostateHolmium-Yag laser enucleation of the prostate |
| Bipolar TURP | Active comparator | Procedure: Bipolar TURPBipolar transurethral resection of the prostate in saline |
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 8 (IPSS) >15 and bother score 8 (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 |
|---|---|---|
| 532nm-laser photoselective vapo-enucleation of the prostate)using Greenlight (532nm-laser) modified vaporization technique, PVEP (photoselective vapo-enucleation of the prostate) | Procedure or surgery | Greenlight (532nm-laser) PVEP |
| Holmium laser enucleation of prostateHolmium-Yag laser enucleation of the prsotate | Procedure or surgery | Holmium laser enucleation of prostate |
| Bipolar TURPBipolar transurethral resection of the prostate in saline | Procedure or surgery | Bipolar TURP |
Primary outcome
Re treatment
Time frame: 3 YEARs
need for retreatment for recurrent infravesical obstruction following primary surgery
2 secondary outcomes
change in symptoms score
Time frame: 3 year
Urine Flow rate (ml/sec)
Time frame: 3 year
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 16 Oct 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 study testing 532nm-laser photoselective vapo-enucleation of the prostate), Holmium laser enucleation of prostate and Bipolar TURP in people with Benign Prostate Hyperplasia and Lower Urinary Tract Symptoms, 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 16 Oct 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.
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?
Re treatment (time frame: 3 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 16 Oct 2019.