Prostate HyperplasiaPhase 3enucleationNCT04275076
HoLEP Vs BPEP for Large Prostatic Adenoma
A Phase 3 study testing Holmium laser enucleation of the prostate versus bipolar transurethral enucleation of the prostate in management of benign prostatic hyperplasia in people with Prostate Hyperplasia, run by Ahmed Maher Gamil Ahmed Higazy at 1 site in Egypt.
Trial summary
Benign prostatic hyperplasia (BPH) is one of the most common urinary disorders in elderly males. The symptoms of BPH include impaired physiological and functional well-being, which interferes with daily living. At present, transurethral resection of the prostate (TURP) is the standard surgical treatment. Read more about this study
- Who is it for?
- Any age, men only
- Conditions the study is for
- Prostate Hyperplasia
- What is being tested?
- Holmium laser enucleation of the prostate versus bipolar transurethral enucleation of the prostate in management of benign prostatic hyperplasia
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Feb 2018to 1 Feb 2020
- Phase
- Phase 3
- 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
- Men who are fit for surgery and need a surgical resection of the prostate larger than 80 ml including:
- Bothersome LUTS with an IPSS score over 19
- Refractory hematuria
- Upper urinary tract affection
- Recurrent UTI secondary to prostatic enlargement
- Maximum uroflow rate (Qmax) below 10 ml/sec.
- bladder diverticula
- Urinary retention whether recurrent acute attacks with failure of medical treatment or chronic retention.
Who cannot join
- Patients with:
- Neurogenic bladder
- Previous prostate or urethral surgery
- Associated urethral stricture
- Prostate cancer diagnosed by TRUS biopsy
- Bladder stones,
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Holmium Laser Enucleation of the Prostate Versus Bipolar Transurethral Enucleation of the Prostate in Management of Benign Prostatic Hyperplasia A Randomized Controlled Trial
Benign prostatic hyperplasia (BPH) is one of the most common urinary disorders in elderly males. The symptoms of BPH include impaired physiological and functional well-being, which interferes with daily living.
At present, transurethral resection of the prostate (TURP) is the standard surgical treatment. However, the high rate of complications associated with TURP is a major drawback of this procedure.
Holmium laser enucleation of the prostate (HoLEP) was proven to be an effective surgical treatment for BPH with no prostate size limitation with adequate hemostasis, bipolar enucleation of the prostate (BPEP) has been introduced as an alternative energy source with a promising outcome with equal safety and efficacy
Read the detailed description
Enlarged prostate represents the most common cause of lower urinary tract symptoms (LUTS) in elderly men including irritative, obstructive urinary symptoms or even urinary retention that significantly affects the quality life (QoL).
Transurethral resection of the prostate (TURP) represents the standard surgical technique for the management of benign prostatic hyperplasia (BPH) with a prostate size less than 80 ml. However, considerable morbidities are associated with larger sizes.
Endoscopic enucleation of the prostate (EEP) has been recognized as a treatment option for large prostatic adenomas, since first described by Hiraoka et.al, in 1986, it started to gain popularity despite the long learning curve. Many studies have evaluated its efficacy against the gold standard open prostatectomy in large prostate size more than 80ml and showed its safety and efficacy.
EEP represents an anatomical surgical technique resembling a surgeon's finger in open prostatectomy where any energy source that provides adequate haemostasis could be used. Many studies concluded that EEP relies on the surgeon's skills rather than the energy source itself. Holmium laser enucleation of the prostate (HoLEP) was first described by Gilling in 1998 and was proven to be effective with no prostate size limitation with adequate haemostasis, recently it has been approved as a standard treatment for large prostatic adenoma, bipolar enucleation of the prostate (BPEP) has been introduced as an alternative energy source with a promising outcome with equal safety and efficacy.
Few studies evaluated both techniques, one study was done by Shoma et al. showing no statistical difference regarding safety and efficacy between both techniques, another study conducted by Enikeev et al. reported earlier recovery and catheter removal with HoLEP compared to BPEP. However, cost-effectiveness was never been evaluated before between both techniques especially in developing countries.
With such scarce information, the investigators aimed through this study to compare these two energy sources in the enucleation procedure of the prostate in terms of safety, efficacy, and cost-effectiveness in the management of BPH in large prostatic adenoma more than 80 ml.
- Conditions
- Prostate Hyperplasia
- Being tested
- Holmium laser enucleation of the prostate versus bipolar transurethral enucleation of the prostate in management of benign prostatic hyperplasia
- Medical subject headings
- Prostatic Hyperplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Holmium laser enucleation of the prostate versus bipolar transurethral enucleation of the prostate in management of benign prostatic hyperplasiaProcedure or surgery
comparison between 2 energy sources of enucleation in management of benign prostatic hyperplasia, holmium laser versus bipolar energy source in trans-urethral enucleation of the prostate
| Study group | Role | What they receive |
|---|---|---|
| Holmium laser enucleation of the prostate | Experimental | Holmium laser enucleation of the prostate Receives: Procedure: Holmium laser enucleation of the prostate versus bipolar transurethral enucleation of the prostate in management of benign prostatic hyperplasia |
| bipolar transurethral enucleation of the prostate | Experimental | bipolar transurethral enucleation of the prostate Receives: Procedure: Holmium laser enucleation of the prostate versus bipolar transurethral enucleation of the prostate in management of benign prostatic hyperplasia |
What is being measured
The primary outcome is the main question the study is designed to answer.
operative time
form the beginning of endoscopic procedure till catheter insertion
Measured: 50-120 minutes
Secondary outcomes (22)
Enucleation efficacy of HoLEP
Mean Enucleation time (HoLEP) in minutes divided by Mean resected volume in grams
Measured: 12 months
Enucleation efficacy of BEEP
Mean Enucleation time (BPEP) in minutes/ Mean resected volume in grams
Measured: 12 months
Mean energy in (HoLEP) in joules
Mean energy in (HoLEP) in joules
Measured: intra-operative finding
irrigation fluid
Average Irrigation fluid used in each group in liters
Measured: intra-operative finding
catheter removal time
postoperative time till catheter removal
Measured: 1-7 days
resected volume
resected volume in grams
Measured: intra-operative finding
hemoglobin drop
blood loss in dl/ml
Measured: intra-operative finding
conversion to other type of surgery
conversion to other types of surgeries like TURP, open surgery, procedure abortion
Measured: intra-operative finding
Operative safety:
capsular perforation, Yes/No
Measured: intra-operative finding
Operative safety:
morcellation injury, Yes/No
Measured: intra-operative finding
early post operative complication
stress incontinence, Yes/No
Measured: 1 month
early post operative complication
urinary tract infection, Yes/No
Measured: 1 month
early post operative complication
urine retention, Yes/No
Measured: 1 month
Postoperative efficacy:
IPSS: international prostate symptom score
Measured: 12 months
Postoperative efficacy:
QoL: quality of life questionnaire
Measured: 12 months
Postoperative efficacy:
Qmax (m/sec.) : peak flow rate
Measured: 12 months
Postoperative efficacy:
PVRU (ml): post voiding residual urine
Measured: 12 months
Postoperative efficacy:
PSA (ng/ml): prostatic specific antigen
Measured: 12 months
Postoperative efficacy:
postoperative prostate volume assessment in grams
Measured: 12 months
cost effectiveness
Running cost in Egyptian pounds of the following: irrigation fluid, hospital stay, fiber, loop, management of complication in each group
Measured: 12 months
hospital stay
duration of postoperative hospital stay in days
Measured: 1-7 days
Cost analysis
average running cost evaluation in both procedure
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 Feb 2020
- Study start1 Feb 2018
- Primary completion1 Feb 2020
- Study completion1 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ahmed Maher Gamil Ahmed Higazy
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Ahmed Maher Gamil Ahmed Higazy, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04275076
- Sponsor's protocol ID
- FWA000017585.
- Acronym
- enucleation
- Status last verified
- Jun 2020
- First submitted
- 12 Feb 2020
- Last updated
- 16 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Holmium Laser Enucleation of the Prostate Versus Bipolar Transurethral Enucleation of the Prostate in Management of Benign Prostatic Hyperplasia A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04275076
- Acronym / sponsor ID
- enucleation / FWA000017585.
- Conditions
- Prostate Hyperplasia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Ahmed Maher Gamil Ahmed HigazyUniversity, hospital or other
- Study start
- 1 Feb 2018 (actual)
- Primary completion
- 1 Feb 2020 (actual)
- Study completion
- 1 Feb 2020 (actual)
- First posted
- 19 Feb 2020 (actual)
- 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.
Benign prostatic hyperplasia (BPH) is one of the most common urinary disorders in elderly males. The symptoms of BPH include impaired physiological and functional well-being, which interferes with daily living.
At present, transurethral resection of the prostate (TURP) is the standard surgical treatment. However, the high rate of complications associated with TURP is a major drawback of this procedure.
Holmium laser enucleation of the prostate (HoLEP) was proven to be an effective surgical treatment for BPH with no prostate size limitation with adequate hemostasis, bipolar enucleation of the prostate (BPEP) has been introduced as an alternative energy source with a promising outcome with equal safety and efficacy
Detailed description
Enlarged prostate represents the most common cause of lower urinary tract symptoms (LUTS) in elderly men including irritative, obstructive urinary symptoms or even urinary retention that significantly affects the quality life (QoL).
Transurethral resection of the prostate (TURP) represents the standard surgical technique for the management of benign prostatic hyperplasia (BPH) with a prostate size less than 80 ml. However, considerable morbidities are associated with larger sizes.
Endoscopic enucleation of the prostate (EEP) has been recognized as a treatment option for large prostatic adenomas, since first described by Hiraoka et.al, in 1986, it started to gain popularity despite the long learning curve. Many studies have evaluated its efficacy against the gold standard open prostatectomy in large prostate size more than 80ml and showed its safety and efficacy.
EEP represents an anatomical surgical technique resembling a surgeon's finger in open prostatectomy where any energy source that provides adequate haemostasis could be used. Many studies concluded that EEP relies on the surgeon's skills rather than the energy source itself. Holmium laser enucleation of the prostate (HoLEP) was first described by Gilling in 1998 and was proven to be effective with no prostate size limitation with adequate haemostasis, recently it has been approved as a standard treatment for large prostatic adenoma, bipolar enucleation of the prostate (BPEP) has been introduced as an alternative energy source with a promising outcome with equal safety and efficacy.
Few studies evaluated both techniques, one study was done by Shoma et al. showing no statistical difference regarding safety and efficacy between both techniques, another study conducted by Enikeev et al. reported earlier recovery and catheter removal with HoLEP compared to BPEP. However, cost-effectiveness was never been evaluated before between both techniques especially in developing countries.
With such scarce information, the investigators aimed through this study to compare these two energy sources in the enucleation procedure of the prostate in terms of safety, efficacy, and cost-effectiveness in the management of BPH in large prostatic adenoma more than 80 ml.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Holmium laser enucleation of the prostate | Experimental | Procedure: Holmium laser enucleation of the prostate versus bipolar transurethral enucleation of the prostate in management of benign prostatic hyperplasiaHolmium laser enucleation of the prostate |
| bipolar transurethral enucleation of the prostate | Experimental | Procedure: Holmium laser enucleation of the prostate versus bipolar transurethral enucleation of the prostate in management of benign prostatic hyperplasiabipolar transurethral enucleation of the prostate |
Who may qualify
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (8 listed)
- Men who are fit for surgery and need a surgical resection of the prostate larger than 80 ml including:
Key exclusion criteria (6 listed)
- Patients with:
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 |
|---|---|---|
| Holmium laser enucleation of the prostate versus bipolar transurethral enucleation of the prostate in management of benign prostatic hyperplasiacomparison between 2 energy sources of enucleation in management of benign prostatic hyperplasia, holmium laser versus bipolar energy source in trans-urethral enucleation of the prostate | Procedure or surgery | Holmium laser enucleation of the prostate, bipolar transurethral enucleation of the prostate |
Primary outcome
operative time
Time frame: 50-120 minutes
form the beginning of endoscopic procedure till catheter insertion
22 secondary outcomes
Enucleation efficacy of HoLEP
Time frame: 12 months
Enucleation efficacy of BEEP
Time frame: 12 months
Mean energy in (HoLEP) in joules
Time frame: intra-operative finding
irrigation fluid
Time frame: intra-operative finding
catheter removal time
Time frame: 1-7 days
resected volume
Time frame: intra-operative finding
hemoglobin drop
Time frame: intra-operative finding
conversion to other type of surgery
Time frame: intra-operative finding
Operative safety:
Time frame: intra-operative finding
Operative safety:
Time frame: intra-operative finding
early post operative complication
Time frame: 1 month
early post operative complication
Time frame: 1 month
early post operative complication
Time frame: 1 month
Postoperative efficacy:
Time frame: 12 months
Postoperative efficacy:
Time frame: 12 months
Postoperative efficacy:
Time frame: 12 months
Postoperative efficacy:
Time frame: 12 months
Postoperative efficacy:
Time frame: 12 months
Postoperative efficacy:
Time frame: 12 months
cost effectiveness
Time frame: 12 months
hospital stay
Time frame: 1-7 days
Cost analysis
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 16 Jun 2020.
- Individual participant dataSharing planned: No
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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.
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 Phase 3 study testing Holmium laser enucleation of the prostate versus bipolar transurethral enucleation of the prostate in management of benign prostatic hyperplasia in people with Prostate Hyperplasia, run by Ahmed Maher Gamil Ahmed Higazy 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 8 inclusion and 6 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 Jun 2020. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
operative time (time frame: 50-120 minutes). 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 Jun 2020.