Benign Prostate HyperplasiaPhase 4NCT01494337
Holmium Laser Enucleation of Prostate(HOLEP) vs Greenlight(XPS) Laser Photoselective Vapo-Enucleation of Prostate(PVEP)
A Phase 4 study testing HOLEP and PVEP-XPS in people with Benign Prostate Hyperplasia, run by Royal Victoria Hospital, Canada at 1 site in Canada.
Trial summary
The investigators are now proposing to compare two laser techniques for treating Benign prostate hyperplasia (BPH); Holmium Laser Enucleation of the Prostate (HOLEP) versus (greenlight) XPS which is a recently available technology in our center and is more efficient hence our choice to include patients with any size… Read more about this study
- Who is it for?
- Any age, men only
- Conditions the study is for
- Benign Prostate Hyperplasia
- What is being tested?
- HOLEP and PVEP-XPS
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 108 participants
- Where
- 1 siteCanada
- Study dates
- Jan 2012to Apr 2014
- 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 Any age
- Men only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Ability to give informed consent.
- Lower urinary symptoms (LUTS) secondary to bladder outlet obstruction from BPH.
- Failed medical treatment of BPH.
- International prostate symptom scores (IPSS) > 15.
- Peak urinary flow rate (Qmax) < 15 ml/sec.
- Preoperative TRUS (transrectal ultrasound) size of the gland (from 40 to 150 cc).
- Patients in retention secondary to BPH (with cystometrogram (CMG) confirming adequate detrusor pressure if the bladder capacity at time of catheterization is in excess of 1000 ml).
Who cannot join
- Inability to give informed consent.
- Patient who have a 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 cancer prostate 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 Study Comparing Holmium Laser Enucleation of the Prostate (HOLEP) Versus Greenlight (XPS) Laser Photoselective Vapo-Enucleation of Prostate(PVEP) in the Management of Infravesical Obstruction Secondary to BPH
The investigators are now proposing to compare two laser techniques for treating Benign prostate hyperplasia (BPH); Holmium Laser Enucleation of the Prostate (HOLEP) versus (greenlight) XPS which is a recently available technology in our center and is more efficient hence our choice to include patients with any size prostate. This will confirm whether the two techniques are equivalent in efficacy and safety independent of size as well as cost. The two techniques are available world wide as standard of care
Read the detailed description
Patients with lower urinary tract symptoms (LUTS) secondary to bladder outlet obstruction from BPH seen through the outpatient clinic in the urology department will be assessed to see if the patient satisfies all inclusion and exclusion criteria. Patients who are meeting these criteria will be asked to participate in this randomized comparison study. If they agree they will be provided with an informed consent form which they can take home with them. The randomization process will be performed using computer-generated simple random tables in a 1:1 ratio. Study participants will be enrolled randomized, and the appropriate surgery scheduled. Procedures will be performed on an outpatient basis whenever possible.
All surgeries will be performed under a spinal or general anaesthesia. In case of coexisting vesical stone, Holmium laser cystolithotripsy will be done first regardless the type of next procedure for the prostate. Both HOLEP and greenLight (XPS) laser vaporization of the prostate begins with the insertion of a resectoscope transurethrally. Examination of the lower urinary tract is performed and holmium laser fiber is used to enucleate (HOLEP) or to vaporize [greenLight (XPS)] the obstructing prostatic tissue using the Moxy fibre until the surgical capsule is reached. After treatment, the prostatic fossa will be examined for hemostasis and if adequate, a 22 french Foley catheter will be inserted. Patients will then be sent to the post-anaesthetic recovery room.
Once awake, the patient could have the catheter removed with a voiding trial if the urine is judged to be sufficiently clear and the surgeon is comfortable about early catheter removal. Those patients able to void will be sent home without catheter. Those patients unable to void or the surgeon decides to keep the catheter for 24 hours will be either sent home with a catheter to be removed the next day or hospitalized overnight.
Finally, those patients with multiple medical problems or with postoperative bleeding requiring bladder irrigation will be kept overnight with a trial of voiding attempted the next morning if the urine is clear.
Intraoperative and early postoperative parameters of interest will be recorded and compared between groups. These parameters include the total procedure time, total laser energy used, cost of disposables including the number of laser fibers per case, number of bags of irrigant per case, urethral catheterization time, length of hospital stay, subjective assessment of hemostasis during each laser procedure, objective assessment of changes in serum electrolytes and hematocrit and thorough recording of all complications.
Patients will be seen in follow-up at 2 weeks, 1, 3, 6, and 12 months. The parameters to be assessed at each time point are listed below. As can be seen from the table, the most important parameters will be changes in voiding symptoms and uroflowmetry over time. Some validated questionnaires will be utilized to assess the patients' sexual function both at base line and at different follow-up visits. Different aspects of the sexual function will be analysed, partner's feedback will be addressed by a special questionnaire.
- Conditions
- Benign Prostate Hyperplasia
- Being tested
- HOLEP, PVEP-XPS
- Keywords
- LASER, BPH, Prostate surgery, HOLEP, Green light PVP
- 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
Also called Holmium Laser Enucleation of The Prostate
USING HOLMIUM LASER, the prostate adenoma will be enucleated and removed into small pieces
PVEP-XPSProcedure or surgery
Also called Photoselective Vapo-Enucleation of prostate(PVEP)
Greenlight laser will be used with high power setting for selective vaporization of the prostate adenoma, using 180 watt XPS laser machine
| Study group | Role | What they receive |
|---|---|---|
| HOLEP | Active comparator | HOLEP In the first arm, holmium laser enucleation of the prostate will be done Receives: Procedure: HOLEP |
| PVEP/XPS | Active comparator | PVEP/XPS green light photoselective Vapo-Enucleation of prostate using XPS 180W machine will be used in the second arm Receives: Procedure: PVEP-XPS |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in urine flow parameters
change in urine flow parameters; IPSS= international prostate symptom score QOL= quality of life score PVR= post voiding residual urine Q-MAX= maximal flow rate
Measured: one, 4 and 12 months postoperative
Secondary outcomes (2)
TIME TO CATHETER REMOVAL, HOSPITAL STAY
At first postoperative day; the catheter will be removed for trial voiding Patient will be discharged from the hospital as soon as possible (same day or once urine color is normalized)
Measured: 1 day post operative
the need for redo surgery
The need for re-operation in the fist year will be assessed
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2011 (estimated)
- Study startJan 2012
- Primary completionMar 2014
- Study completionApr 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Benign Prostate HyperplasiaStudies 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
- 108 participants (actual)
Sponsor and investigators
- Lead sponsor
- Royal Victoria Hospital, Canada
- Sponsor type
- University, hospital or other
- Collaborators
- McGill University
- Responsible party
- Principal investigator, Mostafa Elhilali, Royal Victoria Hospital, Canada
- Investigators
- Mostafa M Elhilali, Professor, Principal investigator, McGill University Health Centre/Research Institute of the McGill University Health Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01494337
- Sponsor's protocol ID
- 11-171-SDR
- Status last verified
- Aug 2014
- First submitted
- 5 Dec 2011
- Last updated
- 26 Aug 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Elshal AM, Elkoushy MA, El-Nahas AR, Shoma AM, Nabeeh A, Carrier S, Elhilali MM. GreenLight laser (XPS) photoselective vapo-enucleation versus holmium laser enucleation of the prostate for the treatment of symptomatic benign prostatic hyperplasia: a randomized controlled study. J Urol. 2015 Mar;193(3):927-34. doi: 10.1016/j.juro.2014.09.097. Epub 2014 Sep 28.
PubMed 25261801
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Study Comparing Holmium Laser Enucleation of the Prostate (HOLEP) Versus Greenlight (XPS) Laser Photoselective Vapo-Enucleation of Prostate(PVEP) in the Management of Infravesical Obstruction Secondary to BPH
- ClinicalTrials.gov ID
- NCT01494337
- Acronym / sponsor ID
- 11-171-SDR
- Conditions
- Benign Prostate Hyperplasia
- Keywords
- LASER, BPH, Prostate surgery, HOLEP, Green light PVP
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 108 participants (actual)
- Lead sponsor
- Royal Victoria Hospital, CanadaUniversity, hospital or other
- Collaborators
- McGill University
- Study start
- Jan 2012
- Primary completion
- Mar 2014 (actual)
- Study completion
- Apr 2014 (actual)
- First posted
- 19 Dec 2011 (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 investigators are now proposing to compare two laser techniques for treating Benign prostate hyperplasia (BPH); Holmium Laser Enucleation of the Prostate (HOLEP) versus (greenlight) XPS which is a recently available technology in our center and is more efficient hence our choice to include patients with any size prostate. This will confirm whether the two techniques are equivalent in efficacy and safety independent of size as well as cost. The two techniques are available world wide as standard of care
Detailed description
Patients with lower urinary tract symptoms (LUTS) secondary to bladder outlet obstruction from BPH seen through the outpatient clinic in the urology department will be assessed to see if the patient satisfies all inclusion and exclusion criteria. Patients who are meeting these criteria will be asked to participate in this randomized comparison study. If they agree they will be provided with an informed consent form which they can take home with them. The randomization process will be performed using computer-generated simple random tables in a 1:1 ratio. Study participants will be enrolled randomized, and the appropriate surgery scheduled. Procedures will be performed on an outpatient basis whenever possible.
All surgeries will be performed under a spinal or general anaesthesia. In case of coexisting vesical stone, Holmium laser cystolithotripsy will be done first regardless the type of next procedure for the prostate. Both HOLEP and greenLight (XPS) laser vaporization of the prostate begins with the insertion of a resectoscope transurethrally. Examination of the lower urinary tract is performed and holmium laser fiber is used to enucleate (HOLEP) or to vaporize [greenLight (XPS)] the obstructing prostatic tissue using the Moxy fibre until the surgical capsule is reached. After treatment, the prostatic fossa will be examined for hemostasis and if adequate, a 22 french Foley catheter will be inserted. Patients will then be sent to the post-anaesthetic recovery room.
Once awake, the patient could have the catheter removed with a voiding trial if the urine is judged to be sufficiently clear and the surgeon is comfortable about early catheter removal. Those patients able to void will be sent home without catheter. Those patients unable to void or the surgeon decides to keep the catheter for 24 hours will be either sent home with a catheter to be removed the next day or hospitalized overnight.
Finally, those patients with multiple medical problems or with postoperative bleeding requiring bladder irrigation will be kept overnight with a trial of voiding attempted the next morning if the urine is clear.
Intraoperative and early postoperative parameters of interest will be recorded and compared between groups. These parameters include the total procedure time, total laser energy used, cost of disposables including the number of laser fibers per case, number of bags of irrigant per case, urethral catheterization time, length of hospital stay, subjective assessment of hemostasis during each laser procedure, objective assessment of changes in serum electrolytes and hematocrit and thorough recording of all complications.
Patients will be seen in follow-up at 2 weeks, 1, 3, 6, and 12 months. The parameters to be assessed at each time point are listed below. As can be seen from the table, the most important parameters will be changes in voiding symptoms and uroflowmetry over time. Some validated questionnaires will be utilized to assess the patients' sexual function both at base line and at different follow-up visits. Different aspects of the sexual function will be analysed, partner's feedback will be addressed by a special questionnaire.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HOLEP | Active comparator | Procedure: HOLEPHOLEP In the first arm, holmium laser enucleation of the prostate will be done |
| PVEP/XPS | Active comparator | Procedure: PVEP-XPSPVEP/XPS green light photoselective Vapo-Enucleation of prostate using XPS 180W machine will be used in the second arm |
Who may qualify
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- Ability to give informed consent.
- Lower urinary symptoms (LUTS) secondary to bladder outlet obstruction from BPH.
- Failed medical treatment of BPH.
- International prostate symptom scores (IPSS) > 15.
- Peak urinary flow rate (Qmax) < 15 ml/sec.
Key exclusion criteria (5 listed)
- Inability to give informed consent.
- Patient who have a 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 cancer prostate 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 |
|---|---|---|
| HOLEPAlso: Holmium Laser Enucleation of The ProstateUSING HOLMIUM LASER, the prostate adenoma will be enucleated and removed into small pieces | Procedure or surgery | HOLEP |
| PVEP-XPSAlso: Photoselective Vapo-Enucleation of prostate(PVEP)Greenlight laser will be used with high power setting for selective vaporization of the prostate adenoma, using 180 watt XPS laser machine | Procedure or surgery | PVEP/XPS |
Primary outcome
change in urine flow parameters
Time frame: one, 4 and 12 months postoperative
change in urine flow parameters; IPSS= international prostate symptom score QOL= quality of life score PVR= post voiding residual urine Q-MAX= maximal flow rate
2 secondary outcomes
TIME TO CATHETER REMOVAL, HOSPITAL STAY
Time frame: 1 day post operative
the need for redo surgery
Time frame: 1 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 26 Aug 2014.
- Derived from this study: PubMed 25261801Elshal AM, Elkoushy MA, El-Nahas AR, Shoma AM, Nabeeh A, Carrier S, Elhilali MM. GreenLight laser (XPS) photoselective vapo-enucleation versus holmium laser enucleation of the prostate for the treatment of symptomatic benign prostatic hyperplasia: a randomized controlled study. J Urol. 2015 Mar;193(3):927-34. doi: 10.1016/j.juro.2014.09.097. Epub 2014 Sep 28.
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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.
Mostafa M Elhilali, Professor principal investigator
McGill University Health Centre/Research Institute of the McGill University Health Centre
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 PVEP-XPS in people with Benign Prostate Hyperplasia, run by Royal Victoria Hospital, Canada at 1 site in Canada.
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 5 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 26 Aug 2014. 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 Canada. 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?
change in urine flow parameters (time frame: one, 4 and 12 months postoperative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01494337, which also lists 1 linked publication.
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 26 Aug 2014.