BPH With Urinary ObstructionNCT04935151
HoLEP vs BPRP in the Management of a Large Volume (> 80 gm) Symptomatic BPH
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 2 sites in Egypt.
Trial summary
To compare bipolar resection versus holmium laser enucleation for management of symptomatic large BPH (> 80 gm) 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
- 112 participants
- Where
- 2 sitesEgypt
- Study dates
- 4 Dec 2016to 10 Mar 2021
- 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 with 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
2 sites in 1 country.
Egypt2 sites
Cairo University Hospitals
Cairo, 12222
Theodor Bilharz research institute
Giza, 12111
About this study
Official title: Holmium Laser Enucleation Versus Bipolar Resection in the Management of a Large Volume (> 80 gm) Symptomatic BPH: a Randomised Controlled Trial
To compare bipolar resection versus holmium laser enucleation for management of symptomatic large BPH (> 80 gm)
Read the detailed description
To compare safety and efficacy of bipolar resection (BPRP) versus holmium laser enucleation (HoLEP) for management of symptomatic large BPH (> 80 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
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)
change in hemoglobin concentration postoperatively vs preoperatively
Measured: within two hours after surgery
Secondary outcomes (3)
operative duration in minutes
operative duration
Measured: Time lapsed during surgery
Hospital stay
Hospitalisation starting from day of surgery till the day of discharge from Hospital in days
Measured: From time of randomisation up to last day of admission in hospital (in days) up to 30 days
blood transfusion
rate of blood transfusion
Measured: during surgery and hospitalisation up to 10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2021
- Study start4 Dec 2016
- Primary completion6 Mar 2018
- Study completion10 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 112 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
- Mamdouh A Roshdy, M.D, Study director, Theodor Bilharz research institue
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04935151
- Sponsor's protocol ID
- REC-TBRI-PT563
- Status last verified
- Jun 2021
- First submitted
- 6 Jun 2021
- Last updated
- 24 Jun 2021
- Results posted
- No
- Data monitoring committee
- Yes
- 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 24 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Holmium Laser Enucleation Versus Bipolar Resection in the Management of a Large Volume (> 80 gm) Symptomatic BPH: a Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT04935151
- Acronym / sponsor ID
- REC-TBRI-PT563
- Conditions
- BPH With Urinary Obstruction, Male
- Keywords
- BPH, enucleation, Large Prostate, LUTS, IPSS, quality of life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 112 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Collaborators
- Theodor Bilharz Research Institute
- Study start
- 4 Dec 2016 (actual)
- Primary completion
- 6 Mar 2018 (actual)
- Study completion
- 10 Mar 2021 (actual)
- First posted
- 22 Jun 2021 (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 symptomatic large BPH (> 80 gm)
Detailed description
To compare safety and efficacy of bipolar resection (BPRP) versus holmium laser enucleation (HoLEP) for management of symptomatic large BPH (> 80 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 (4 listed)
- Patients suffering from LUTS secondary to infravesical obstruction from BPH with 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 | 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: within two hours after surgery
change in hemoglobin concentration postoperatively vs preoperatively
3 secondary outcomes
operative duration in minutes
Time frame: Time lapsed during surgery
Hospital stay
Time frame: From time of randomisation up to last day of admission in hospital (in days) up to 30 days
blood transfusion
Time frame: during surgery and hospitalisation up to 10 days
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 24 Jun 2021.
- Individual participant dataSharing planned: No
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Anterior Bridge-Preserving Versus Conventional Early Apical Release During Holmium Laser Enucleation of the Prostate
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Preoperative Pelvic Floor Physical Therapy to Minimize Stress Urinary Incontinence After Holmium Laser Enucleation of the Prostate
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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.
Mamdouh A Roshdy, M.D study director
Theodor Bilharz research institue
2 sites 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 2 sites 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 4 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 24 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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: within two hours after surgery). 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 24 Jun 2021.