Benign Prostatic HyperplasiaPhase 4NCT02293759
Trial of HoLEP vs. PVP in Treating BPH in Patients With Bleeding Tendency
A Phase 4 study testing HoLEP and Greenlight laser PVP in people with Benign Prostatic Hyperplasia, run by Mansoura University at 1 site in Egypt.
Trial summary
Patients presented for BPH surgery at our out patient clinic will be assessed for abnormal bleeding profile. Patients with bleeding tendency will be offered either HoLEP or Greenlight laser PVP based on prostate size cut off point of 80ml Larger prostates will be treated with HoLEP Smaller prostates will be treated… 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?
- HoLEP and Greenlight laser PVP
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- Oct 2014to Sep 2016
- 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
- BPH patients candidate for transurethral prostate surgery after failure of medical treatment
- Perioperative uncorrected Blleding tendency
- patients with naturally induced uncorrectable bleeding tendency;
- platelet count less than 100000/mm3
- INR more than 1.5
- Patients on oral antiplatlet that deemed unsafe to stop prior to surgery as per intenist
- Patients on oral anticoagulant that deemed unsafe to stop prior to surgery as per intenist
Who cannot join
- Correctable bleeding tendency
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Urology and Nephrology Center
Al Mansurah, Aldakahlia, 35516
Ahmed M Elshal, MD, 00201001855490, elshalam@hotmail.com
Ahmed M Elshal, MD
About this study
Official title: Prospective Non-randomized Trial Comparing Holmium Laser Enucleation of the Prostate Versus Greenlight Laser Photoselective Vaporization of the Prostate in Treating Benign Prostate Hyperplasia in Patients With Bleeding Tendency
Patients presented for BPH surgery at our out patient clinic will be assessed for abnormal bleeding profile.
Patients with bleeding tendency will be offered either HoLEP or Greenlight laser PVP based on prostate size cut off point of 80ml Larger prostates will be treated with HoLEP Smaller prostates will be treated with greenlight PVP
Read the detailed description
Elderly patients with bleeding tendency either secondary;
- Strict antiplatelet intake
- Strict anticoagulant intake
- uncorrected natural bleeding tendency e.g; patients with liver cell failure are at higher risk of perioperative bleeding when subjected to prostate surgery.
Laser prostate surery was introduced to overcome this difficulty. However, till now there is no head to head comparision of different types of laser procedures in treating this subset of patients In the current study patients presented for BPH surgery in a tertiarry referral prostate unit will be assessed for bleeding tendency and will be treated either by Holmium laser enucleatiuon of the prostate or Greenlight laser vaporization of the prostate Single surgeon will perform all cases
- Conditions
- Benign Prostatic Hyperplasia
- Being tested
- HoLEP, Greenlight laser PVP
- Keywords
- BPH- LASER- PROSTATE- BLEEDING TENDENCY
- Medical subject headings
- Prostatic Hyperplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HoLEPProcedure or surgery
Holmium laser enucleation of the prsotate
Greenlight laser PVPProcedure or surgery
Greenlight laser (532nm) Photoslective vaporization of the prostate
| Study group | Role | What they receive |
|---|---|---|
| HoLEP | Active comparator | Holmium laser enucleation of the prostate Receives: Procedure: HoLEP |
| Greenlight laser PVP | Active comparator | Phtoselective vaporization of the prostate Receives: Procedure: Greenlight laser PVP |
What is being measured
The primary outcome is the main question the study is designed to answer.
perioperative blood loss
Measured: 48 hours
Secondary outcomes (3)
readmission
Measured: 30 days
blood transfusion
Measured: 30 days
flow rate
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2014 (estimated)
- Study startOct 2014
- Primary completionAug 2016 (estimated)
- Study completionSep 2016 (estimated)
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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (estimated)
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
- NCT02293759
- Sponsor's protocol ID
- Mans-2014-04
- Status last verified
- Mar 2016
- First submitted
- 13 Nov 2014
- Last updated
- 29 Mar 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Non-randomized Trial Comparing Holmium Laser Enucleation of the Prostate Versus Greenlight Laser Photoselective Vaporization of the Prostate in Treating Benign Prostate Hyperplasia in Patients With Bleeding Tendency
- ClinicalTrials.gov ID
- NCT02293759
- Acronym / sponsor ID
- Mans-2014-04
- Conditions
- Benign Prostatic Hyperplasia
- Keywords
- BPH- LASER- PROSTATE- BLEEDING TENDENCY
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- Oct 2014
- Primary completion
- Aug 2016 (estimated)
- Study completion
- Sep 2016 (estimated)
- First posted
- 18 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.
Patients presented for BPH surgery at our out patient clinic will be assessed for abnormal bleeding profile.
Patients with bleeding tendency will be offered either HoLEP or Greenlight laser PVP based on prostate size cut off point of 80ml Larger prostates will be treated with HoLEP Smaller prostates will be treated with greenlight PVP
Detailed description
Elderly patients with bleeding tendency either secondary;
- Strict antiplatelet intake
- Strict anticoagulant intake
- uncorrected natural bleeding tendency e.g; patients with liver cell failure are at higher risk of perioperative bleeding when subjected to prostate surgery.
Laser prostate surery was introduced to overcome this difficulty. However, till now there is no head to head comparision of different types of laser procedures in treating this subset of patients In the current study patients presented for BPH surgery in a tertiarry referral prostate unit will be assessed for bleeding tendency and will be treated either by Holmium laser enucleatiuon of the prostate or Greenlight laser vaporization of the prostate Single surgeon will perform all cases
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HoLEP | Active comparator | Procedure: HoLEPHolmium laser enucleation of the prostate |
| Greenlight laser PVP | Active comparator | Procedure: Greenlight laser PVPPhtoselective vaporization of the prostate |
Who may qualify
- Ages
- 50 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- BPH patients candidate for transurethral prostate surgery after failure of medical treatment
- Perioperative uncorrected Blleding tendency
Key exclusion criteria (1 listed)
- Correctable bleeding tendency
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 |
|---|---|---|
| HoLEPHolmium laser enucleation of the prsotate | Procedure or surgery | HoLEP |
| Greenlight laser PVPGreenlight laser (532nm) Photoslective vaporization of the prostate | Procedure or surgery | Greenlight laser PVP |
Primary outcome
perioperative blood loss
Time frame: 48 hours
3 secondary outcomes
readmission
Time frame: 30 days
blood transfusion
Time frame: 30 days
flow rate
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2016.
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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 HoLEP and Greenlight laser PVP 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 7 inclusion and 1 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 29 Mar 2016. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ahmed m Elshal, MD (+20502262222 ext. 1428, ELSHALAM@GMAIL.COM), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
perioperative blood loss (time frame: 48 hours). 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 29 Mar 2016; AzTrials last refreshed its copy on 8 Nov 2026.