BPH With Urinary ObstructionBPHNCT03998150
Holmium Laser vs Bipolar Enucleation of a Large Volume BPH: a Randomised Controlled Study
A study testing Holmium laser enucleation of the prostate and Bipolar plasma kinetic enucleation of the prostate in people with BPH With Urinary Obstruction and Male, run by Cairo University at 1 site in Egypt.
Trial summary
To compare bipolar plasmakinetic enucleation versus holmium laser enucleation for management of large BPH. Read more about this study
- Who is it for?
- Ages 40 years and older, men only
- Conditions the study is for
- BPH With Urinary Obstruction, Male
- What is being tested?
- Holmium laser enucleation of the prostate and Bipolar plasma kinetic enucleation of the prostate
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Nov 2016to 8 Mar 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 40 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients suffering from LUTS secondary to infravesical obstruction from BPH
- failed medical treatment
- International Prostate Symptom Score (IPSS) > 13
- a peak urinary flow rate (Qmax) < 15 ml/sec
- a prostate size ≥ 80 gm
Who cannot join
- presence of a urethral stricture
- neurological disorder
- bladder cancer
- prostate cancer
- previous history of bladder neck surgery or TURP
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Holmium Laser Enucleation Versus Bipolar Plasmakinetic Enucleation of a Large Volume Benign Prostatic Hyperplasia: a Randomised Controlled Study
To compare bipolar plasmakinetic enucleation versus holmium laser enucleation for management of large BPH.
Read the detailed description
To compare safety and efficacy of bipolar plasmakinetic enucleation (BPEP) versus holmium laser enucleation (HoLEP) for management of large BPH (>80gm).
- Conditions
- BPH With Urinary Obstruction, Male
- Being tested
- Holmium laser enucleation of the prostate, Bipolar plasma kinetic enucleation of the prostate
- Keywords
- BPH, enucleation, Prostate, LUTS, IPSS, quality of life, Large prostate
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Holmium laser enucleation of the prostateProcedure or surgery
Also called HoLEP
cystoscopic transurethral enucleation of the prostate using Holmium laser (Asclepion MultiPulse HoPlus 110W and Lumenis pulse 100W and 120W)
Bipolar plasma kinetic enucleation of the prostateProcedure or surgery
Also called BPEP
cystoscopic transurethral enucleation of the prostate using bipolar plasma kinetic energy (KLS Martin Maxium or Covidien Force Triad)
| Study group | Role | What they receive |
|---|---|---|
| HoLEP holmium laser enucleation of the prostate | Active comparator | holmium laser enucleation of the prostate Receives: Procedure: Holmium laser enucleation of the prostate |
| BPEP bipolar plasmakinetic enucleation of the prostate | Active comparator | bipolar plasmakinetic enucleation of the prostate Receives: Procedure: Bipolar plasma kinetic enucleation of the prostate |
What is being measured
The primary outcome is the main question the study is designed to answer.
hemoglobin drop postoperatively (gm/dL)
difference in hemoglobin concentration postoperatively vs preoperatively
Measured: Immediate postoperatively
operative time
operative time in minutes
Measured: during surgery
Secondary outcomes (5)
complications (%)
intraoperative and postoperative complications including blood transfusion, capsular perforation, irritative symptoms, SUI, urethral stricture, bladder neck contracture, urinary retention.
Measured: one year
urine flow
Qmax (ml/s),
Measured: one year
post-voiding residual urine
postvoiding residual urine (ml)
Measured: one year
International prostate symptom score (IPSS)
an international commonly used score ranging from 0 - 35 (the worst is 35) evaluating voiding and storage urinary symptoms using 7 questions each one is scored from 0 to 5 according to severity of symptom
Measured: one year
Quality of life (QoL) section of International prostate symptom score (IPSS)
one question scored from 0 up to 6 (6 is worst)
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2019
- Study start1 Nov 2016
- Primary completion14 Feb 2018
- Study completion8 Mar 2019
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 BPH With Urinary ObstructionStudies of the same condition, open and under way.
- More trials run by Cairo 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Collaborators
- Theodor Bilharz Research Institute
- Responsible party
- Principal investigator, Mohammed Said ElSheemy, Cairo University
- Investigators
- enmar I Habib, Prof., Study director, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03998150
- Sponsor's protocol ID
- 61647
- Acronym
- BPH
- Status last verified
- Jun 2019
- First submitted
- 14 Jun 2019
- Last updated
- 27 Jun 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Habib E, Ayman LM, ElSheemy MS, El-Feel AS, Elkhouly A, Nour HH, Badawy MH, Elbaz AG, Roshdy MA. Holmium Laser Enucleation vs Bipolar Plasmakinetic Enucleation of a Large Volume Benign Prostatic Hyperplasia: A Randomized Controlled Trial. J Endourol. 2020 Mar;34(3):330-338. doi: 10.1089/end.2019.0707. Epub 2020 Feb 28.
PubMed 31813283
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Holmium Laser Enucleation Versus Bipolar Plasmakinetic Enucleation of a Large Volume Benign Prostatic Hyperplasia: a Randomised Controlled Study
- ClinicalTrials.gov ID
- NCT03998150
- Acronym / sponsor ID
- BPH / 61647
- Conditions
- BPH With Urinary Obstruction, Male
- Keywords
- BPH, enucleation, Prostate, LUTS, IPSS, quality of life, Large prostate
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Collaborators
- Theodor Bilharz Research Institute
- Study start
- 1 Nov 2016 (actual)
- Primary completion
- 14 Feb 2018 (actual)
- Study completion
- 8 Mar 2019 (actual)
- First posted
- 26 Jun 2019 (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.
To compare bipolar plasmakinetic enucleation versus holmium laser enucleation for management of large BPH.
Detailed description
To compare safety and efficacy of bipolar plasmakinetic enucleation (BPEP) versus holmium laser enucleation (HoLEP) for management of large BPH (>80gm).
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 |
|---|---|---|
| HoLEP holmium laser enucleation of the prostate | Active comparator | Procedure: Holmium laser enucleation of the prostateholmium laser enucleation of the prostate |
| BPEP bipolar plasmakinetic enucleation of the prostate | Active comparator | Procedure: Bipolar plasma kinetic enucleation of the prostatebipolar plasmakinetic enucleation of the prostate |
Who may qualify
- Ages
- 40 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients suffering from LUTS secondary to infravesical obstruction from BPH
- failed medical treatment
- International Prostate Symptom Score (IPSS) > 13
- a peak urinary flow rate (Qmax) < 15 ml/sec
- a prostate size ≥ 80 gm
Key exclusion criteria (5 listed)
- presence of a urethral stricture
- neurological disorder
- bladder cancer
- prostate cancer
- previous history of bladder neck surgery or TURP
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 prostateAlso: HoLEPcystoscopic transurethral enucleation of the prostate using Holmium laser (Asclepion MultiPulse HoPlus 110W and Lumenis pulse 100W and 120W) | Procedure or surgery | HoLEP holmium laser enucleation of the prostate |
| Bipolar plasma kinetic enucleation of the prostateAlso: BPEPcystoscopic transurethral enucleation of the prostate using bipolar plasma kinetic energy (KLS Martin Maxium or Covidien Force Triad) | Procedure or surgery | BPEP bipolar plasmakinetic enucleation of the prostate |
Primary outcome
hemoglobin drop postoperatively (gm/dL)
Time frame: Immediate postoperatively
difference in hemoglobin concentration postoperatively vs preoperatively
operative time
Time frame: during surgery
operative time in minutes
5 secondary outcomes
complications (%)
Time frame: one year
urine flow
Time frame: one year
post-voiding residual urine
Time frame: one year
International prostate symptom score (IPSS)
Time frame: one year
Quality of life (QoL) section of International prostate symptom score (IPSS)
Time frame: one 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 27 Jun 2019.
- Derived from this study: PubMed 31813283Habib E, Ayman LM, ElSheemy MS, El-Feel AS, Elkhouly A, Nour HH, Badawy MH, Elbaz AG, Roshdy MA. Holmium Laser Enucleation vs Bipolar Plasmakinetic Enucleation of a Large Volume Benign Prostatic Hyperplasia: A Randomized Controlled Trial. J Endourol. 2020 Mar;34(3):330-338. doi: 10.1089/end.2019.0707. Epub 2020 Feb 28.
- Individual participant dataSharing planned: No
Related trials for BPH With Urinary Obstruction
Not yet recruiting
Anterior Bridge-Preserving Versus Conventional Early Apical Release in Bipolar Enucleation of the Prostate
Benign Prostatic Hyperplasia, Benign Prostatic Obstruction
Not yet recruiting
Anterior Bridge-Preserving Versus Conventional Early Apical Release During Holmium Laser Enucleation of the Prostate
Benign Prostatic Hyperplasia, Benign Prostatic Obstruction
Recruiting
Evaluating the Clinical Efficacy of Thulio vs. Holmium Laser Enucleation of the Prostate
BPH With Symptomatic Lower Urinary Tract Symptoms, BPH With Urinary Obstruction
Active, not recruiting
Preoperative Pelvic Floor Physical Therapy to Minimize Stress Urinary Incontinence After Holmium Laser Enucleation of the Prostate
Benign Prostatic Hyperplasia With Outflow Obstruction, Urinary Retention
RecruitingObservational study
Effect of Catheter Duration on Prostate Laser Enucleation Surgery Outcomes in Patients With Urinary Retention
Urinary Retention, Benign Prostate Obstruction (BPO)
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.
enmar I Habib, Prof. study director
Cairo 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 Holmium laser enucleation of the prostate and Bipolar plasma kinetic enucleation of the prostate in people with BPH With Urinary Obstruction and Male, run by Cairo 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 5 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 27 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.
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?
hemoglobin drop postoperatively (gm/dL) (time frame: Immediate postoperatively). The study lists 2 primary outcomes in all. 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 NCT03998150, 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 27 Jun 2019.