BPH With Urinary ObstructionNCT04143399
HoLEP vs BPRP of a Large Volume BPH: a Randomised Controlled Trial
A study testing holmium laser enucleation of the prostate and Bipolar resection 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 resection versus holmium laser enucleation for management of large BPH. Read more about this study
- Who is it for?
- Ages 45 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 resection of the prostate
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 145 participants
- Where
- 1 siteEgypt
- Study dates
- 14 Feb 2016to 10 Jun 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 45 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 ≥ 75 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 vs Bipolar Resection of a Large Volume BPH: a Randomised Controlled Study
To compare bipolar resection versus holmium laser enucleation for management of large BPH.
Read the detailed description
To compare safety and efficacy of bipolar resection (BPRP) versus holmium laser enucleation (HoLEP) for management of large BPH (> 75 gm).
- Conditions
- BPH With Urinary Obstruction, Male
- Being tested
- holmium laser enucleation of the prostate, Bipolar resection of the prostate
- Keywords
- BPH, enucleation, Large Prostate, LUTS, IPSS, quality of life
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 (Versa pulse 100W; Lumenis; Germany)
Bipolar resection of the prostateProcedure or surgery
Also called BPRP
cystoscopic transurethral resection of the prostate using bipolar energy
| Study group | Role | What they receive |
|---|---|---|
| holmium laser enucleation of the prostate | Active comparator | holmium laser enucleation of the prostate (HoLEP) Receives: Procedure: holmium laser enucleation of the prostate |
| bipolar resection of the prostate | Active comparator | bipolar resection of the prostate (BPEP) Receives: Procedure: Bipolar resection 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 duration in minutes
operative duration
Measured: during surgery
Hospital stay in days
Hospital stay
Measured: immediately after surgery
Secondary outcomes (6)
complications (%)
intraoperative and postoperative complications including blood transfusion, capsular perforation, irritative symptoms, SUI, urethral stricture, bladder neck contracture, urinary retention.
Measured: Two years
urine flow
Qmax (ml/s),
Measured: Two years
post-voiding residual urine
postvoiding residual urine (ml)
Measured: Two years
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: Two years
Quality of life (QoL)
section of International prostate symptom score (IPSS) one question scored from 0 up to 6 (6 is worst)
Measured: Two years
Catheter duration
Catheter duration in hours
Measured: immediate postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2019
- Study start14 Feb 2016
- Primary completion1 May 2019
- Study completion10 Jun 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
- 145 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohammed Said ElSheemy, Cairo University
- Investigators
- enmar I Habib, Study director, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04143399
- Sponsor's protocol ID
- 62513
- Status last verified
- Oct 2019
- First submitted
- 26 Oct 2019
- Last updated
- 29 Oct 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Habib EI, ElSheemy MS, Hossam A, Morsy S, Hussein HA, Abdelaziz AY, Abdelazim MS, Fathy H. Holmium Laser Enucleation Versus Bipolar Plasmakinetic Resection for Management of Lower Urinary Tract Symptoms in Patients with Large-Volume Benign Prostatic Hyperplasia: Randomized-Controlled Trial. J Endourol. 2021 Feb;35(2):171-179. doi: 10.1089/end.2020.0636. Epub 2020 Oct 29.
PubMed 32842769
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Holmium Laser Enucleation vs Bipolar Resection of a Large Volume BPH: a Randomised Controlled Study
- ClinicalTrials.gov ID
- NCT04143399
- Acronym / sponsor ID
- 62513
- Conditions
- BPH With Urinary Obstruction, Male
- Keywords
- BPH, enucleation, Large Prostate, LUTS, IPSS, quality of life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 145 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 14 Feb 2016 (actual)
- Primary completion
- 1 May 2019 (actual)
- Study completion
- 10 Jun 2019 (actual)
- First posted
- 29 Oct 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 resection versus holmium laser enucleation for management of large BPH.
Detailed description
To compare safety and efficacy of bipolar resection (BPRP) versus holmium laser enucleation (HoLEP) for management of large BPH (> 75 gm).
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 | Active comparator | Procedure: holmium laser enucleation of the prostateholmium laser enucleation of the prostate (HoLEP) |
| bipolar resection of the prostate | Active comparator | Procedure: Bipolar resection of the prostatebipolar resection of the prostate (BPEP) |
Who may qualify
- Ages
- 45 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 ≥ 75 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 (Versa pulse 100W; Lumenis; Germany) | Procedure or surgery | holmium laser enucleation of the prostate |
| Bipolar resection of the prostateAlso: BPRPcystoscopic transurethral resection of the prostate using bipolar energy | Procedure or surgery | bipolar resection of the prostate |
Primary outcome
hemoglobin drop postoperatively (gm/dL)
Time frame: Immediate postoperatively
difference in hemoglobin concentration postoperatively vs preoperatively
operative duration in minutes
Time frame: during surgery
operative duration
Hospital stay in days
Time frame: immediately after surgery
Hospital stay
6 secondary outcomes
complications (%)
Time frame: Two years
urine flow
Time frame: Two years
post-voiding residual urine
Time frame: Two years
International prostate symptom score (IPSS)
Time frame: Two years
Quality of life (QoL)
Time frame: Two years
Catheter duration
Time frame: immediate postoperatively
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 29 Oct 2019.
- Derived from this study: PubMed 32842769Habib EI, ElSheemy MS, Hossam A, Morsy S, Hussein HA, Abdelaziz AY, Abdelazim MS, Fathy H. Holmium Laser Enucleation Versus Bipolar Plasmakinetic Resection for Management of Lower Urinary Tract Symptoms in Patients with Large-Volume Benign Prostatic Hyperplasia: Randomized-Controlled Trial. J Endourol. 2021 Feb;35(2):171-179. doi: 10.1089/end.2020.0636. Epub 2020 Oct 29.
- Individual participant dataSharing planned: No
Related trials for BPH With Urinary Obstruction
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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
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
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
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 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 resection 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 29 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?
hemoglobin drop postoperatively (gm/dL) (time frame: Immediate postoperatively). The study lists 3 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 NCT04143399, 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 29 Oct 2019.