Prostate HypertrophyNCT03916536
Holmium Laser Versus Thulium Laser Versus Bipolar Enucleation of the Prostate.
A study testing Holmium Laser, Thulium Laser and Bipolar diathermy in people with Prostate Hypertrophy and Holmium Laser, run by Mansoura University at 1 site in Egypt.
Trial summary
Because of the diversity of the studies and deficiency of those comparing various techniques of EEP for treatment of LUTs secondary to BPO in patients with large sized prostate, we aim in this study at testing the non-inferiority of PKEP and ThuLEP to HoLEP in relieving LUTs secondary to BPO in patients prostate size… Read more about this study
- Who is it for?
- Ages 50 years and older, men only
- Conditions the study is for
- Prostate Hypertrophy, Holmium Laser, Thulium Laser
- What is being tested?
- Holmium Laser, Thulium Laser and Bipolar diathermy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 155 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Feb 2019to 1 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 50 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients' age >50 years
- Lower urinary tract symptoms LUTS secondary benigh prostatic obstruction BPO who failed medical treatment
- International prostate symptom scores (IPSS) >15 and bother score quality of life (QOL) > 3 (according to IPSS question 8)
- Maximum urinary flow rate (Q max) <15 ml/sec with at least 150 ml voided volume or cases with acute urine retention secondary to BPO who failed trial of voiding on medical treatment.
- Transrectal ultrasound TRUS estimated total prostate size 80-250cc
Who cannot join
- Patient with neurological disorder which might affect bladder function as cerebrovascular stroke, Parkinson disease
- Active urinary tract infection (positive urine culture) till treatment
- Presence of bladder cancer (within the last 2 years)
- Known prostate cancer 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.
Egypt1 site
Urology and Nephrology Center
Al Mansurah, Dakahlia Governorate, 35516
About this study
Official title: Holmium Laser Versus Thulium Laser Versus Bipolar Enucleation of the Prostate for Treatment of Large Sized Benign Prostatic Enlargement. A Randomized Controlled Trial
Because of the diversity of the studies and deficiency of those comparing various techniques of EEP for treatment of LUTs secondary to BPO in patients with large sized prostate, we aim in this study at testing the non-inferiority of PKEP and ThuLEP to HoLEP in relieving LUTs secondary to BPO in patients prostate size >80ml. Our hypothesis is to present an evidence that enucleation is a technique rather than a power dependent procedure through a RCT.
- Conditions
- Prostate Hypertrophy, Holmium Laser, Thulium Laser, Bipolar Diathermy, Prostate Enucleation
- Being tested
- Holmium Laser, Thulium Laser, Bipolar diathermy
- Keywords
- Holmium Laser, Thulium Laser, Bipolar diathermy, prostate enucleation
- 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 LaserProcedure or surgery
Also called HoLEP
Holmium laser enucleation of large sized prostate
Thulium LaserProcedure or surgery
Also called ThuLEP
Thulium laser enucleation of large sized prostate
Bipolar diathermyProcedure or surgery
Also called Bipolar enucleation
Bipolar enucleation of large sized prostate
| Study group | Role | What they receive |
|---|---|---|
| Holmium Laser | Active comparator | holmium laser enucleation of the prosteate Receives: Procedure: Holmium Laser |
| Thulium Laser | Active comparator | Thulium laser enucleation of the prosteate Receives: Procedure: Thulium Laser |
| Bipolar Enucleation | Active comparator | Bipolar enucleation of the prosteate Receives: Procedure: Bipolar diathermy |
What is being measured
The primary outcome is the main question the study is designed to answer.
urinary functional outcomes using uroflowmetry
assessed by maximum flow rate (Q-max) measured using uroflowmetry by ml/sec, better outcome above 15ml/sec
Measured: 2 years
Secondary outcomes (2)
patient symptoms
assessed by international prostate symptoms score (IPSS) questionnaire, better outcome score below 9
Measured: 2 years
perioperative complications
assessed by clavien dindo score
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2019
- Study start1 Feb 2019
- Primary completion1 Mar 2021
- Study completion1 Mar 2021
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 Prostate HypertrophyStudies of the same condition, open and under way.
- More trials run by Mansoura 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
- None (open label)
- Enrolment
- 155 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fady kamal Ghobrial, Mansoura University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03916536
- Sponsor's protocol ID
- Prostate Enucleation
- Status last verified
- Sep 2021
- First submitted
- 13 Apr 2019
- Last updated
- 21 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Shoma AM, Ghobrial FK, El-Tabey N, El-Hefnawy AS, El-Kappany HA. A randomized trial of holmium laser vs thulium laser vs bipolar enucleation of large prostate glands. BJU Int. 2023 Dec;132(6):686-695. doi: 10.1111/bju.16174. Epub 2023 Sep 28.
PubMed 37667842
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Holmium Laser Versus Thulium Laser Versus Bipolar Enucleation of the Prostate for Treatment of Large Sized Benign Prostatic Enlargement. A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03916536
- Acronym / sponsor ID
- Prostate Enucleation
- Conditions
- Prostate Hypertrophy, Holmium Laser, Thulium Laser, Bipolar Diathermy, Prostate Enucleation
- Keywords
- Holmium Laser, Thulium Laser, Bipolar diathermy, prostate enucleation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 155 participants (actual)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 1 Feb 2019 (actual)
- Primary completion
- 1 Mar 2021 (actual)
- Study completion
- 1 Mar 2021 (actual)
- First posted
- 16 Apr 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.
Because of the diversity of the studies and deficiency of those comparing various techniques of EEP for treatment of LUTs secondary to BPO in patients with large sized prostate, we aim in this study at testing the non-inferiority of PKEP and ThuLEP to HoLEP in relieving LUTs secondary to BPO in patients prostate size >80ml. Our hypothesis is to present an evidence that enucleation is a technique rather than a power dependent procedure through a RCT.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Holmium Laser | Active comparator | Procedure: Holmium Laserholmium laser enucleation of the prosteate |
| Thulium Laser | Active comparator | Procedure: Thulium LaserThulium laser enucleation of the prosteate |
| Bipolar Enucleation | Active comparator | Procedure: Bipolar diathermyBipolar enucleation of the prosteate |
Who may qualify
- Ages
- 50 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients' age >50 years
- Lower urinary tract symptoms LUTS secondary benigh prostatic obstruction BPO who failed medical treatment
- International prostate symptom scores (IPSS) >15 and bother score quality of life (QOL) > 3 (according to IPSS question 8)
- Maximum urinary flow rate (Q max) <15 ml/sec with at least 150 ml voided volume or cases with acute urine retention secondary to BPO who failed trial of voiding on medical treatment.
- Transrectal ultrasound TRUS estimated total prostate size 80-250cc
Key exclusion criteria (4 listed)
- Patient with neurological disorder which might affect bladder function as cerebrovascular stroke, Parkinson disease
- Active urinary tract infection (positive urine culture) till treatment
- Presence of bladder cancer (within the last 2 years)
- Known prostate cancer 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 |
|---|---|---|
| Holmium LaserAlso: HoLEPHolmium laser enucleation of large sized prostate | Procedure or surgery | Holmium Laser |
| Thulium LaserAlso: ThuLEPThulium laser enucleation of large sized prostate | Procedure or surgery | Thulium Laser |
| Bipolar diathermyAlso: Bipolar enucleationBipolar enucleation of large sized prostate | Procedure or surgery | Bipolar Enucleation |
Primary outcome
urinary functional outcomes using uroflowmetry
Time frame: 2 years
assessed by maximum flow rate (Q-max) measured using uroflowmetry by ml/sec, better outcome above 15ml/sec
2 secondary outcomes
patient symptoms
Time frame: 2 years
perioperative complications
Time frame: 2 years
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 21 Sep 2021.
- Derived from this study: PubMed 37667842Shoma AM, Ghobrial FK, El-Tabey N, El-Hefnawy AS, El-Kappany HA. A randomized trial of holmium laser vs thulium laser vs bipolar enucleation of large prostate glands. BJU Int. 2023 Dec;132(6):686-695. doi: 10.1111/bju.16174. Epub 2023 Sep 28.
- 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 study testing Holmium Laser, Thulium Laser and Bipolar diathermy in people with Prostate Hypertrophy and Holmium Laser, run by Mansoura 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 4 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 21 Sep 2021. 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?
urinary functional outcomes using uroflowmetry (time frame: 2 years). 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 NCT03916536, 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 21 Sep 2021.