Benign Prostatic Hyperplasia With Outflow ObstructionNCT07410390
Short Term Outcomes Of Bipolar Prostate Resection (BPR) Versus Diode Laser Ablation Versus Holmium Laser Enucleation Of Prostate Above 80 Grams With Minimum One Year Follow Up Duration.
A study testing bipolar resection of the prostate, holimum laser enucleation of the prostate and diode laser ablation of the prostate in people with Benign Prostatic Hyperplasia With Outflow Obstruction, run by Ain Shams University.
Trial summary
Randomized Controlled Study Comparing Safety, Efficacy and Short Term Outcomes Of Bipolar Prostate Resection (BPR) Versus Diode Laser Ablation Versus Holmium Laser Enucleation Of Prostate Above 80 Grams With Minimum One Year Follow Up Duration. Read more about this study
- Who is it for?
- Ages 55 to 85 years, men only
- Conditions the study is for
- Benign Prostatic Hyperplasia With Outflow Obstruction
- What is being tested?
- bipolar resection of the prostate, holimum laser enucleation of the prostate and diode laser ablation of the prostate
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 105 participants
- Where
- No sites listed yet
- Study dates
- 20 Feb 2026to 30 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 55 to 85 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Refractory LUTS secondary to benign prostatic hyperplasia (BPH)
- Acute retention secondary to BPH who failed medical treatment
- Prostate size above 80 gm in Pelvi-Abdominal ultrasound or Trans-Rectal ultrasound
Who cannot join
- Suspected Neurogenic bladder.
- Suspected Prostatic adenocarcinoma (either by digital rectal examination or high PSA level)
- Urinary bladder carcinoma
- urethral stricture. previous bladder, urethral or prostate surgery.
- Bleeding tendency.
- Uncontrolled bleeding disorders.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Randomized Controlled Study Comparing Safety, Efficacy and Short Term Outcomes Of Bipolar Prostate Resection (BPR) Versus Diode Laser Ablation Versus Holmium Laser Enucleation Of Prostate Above 80 Grams With Minimum One Year Follow Up Duration.
Randomized Controlled Study Comparing Safety, Efficacy and Short Term Outcomes Of Bipolar Prostate Resection (BPR) Versus Diode Laser Ablation Versus Holmium Laser Enucleation Of Prostate Above 80 Grams With Minimum One Year Follow Up Duration.
Read the detailed description
comparing three different techniques for treatment of prostatomegaly (BPH) bipolar resection of the prostate versus diode laser ablation of the prostate versus holmium laser enucleation monitoring preoperative data . intraoperative data , postoperative outcomes and long term outcomes within 1 year of the operation aiming to decide which technique has the superior hand over other regarding large size prostate above 80 grams
- Being tested
- bipolar resection of the prostate, holimum laser enucleation of the prostate, diode laser ablation of the prostate
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
bipolar resection of the prostateProcedure or surgery
bipolar resection of the prostate
holimum laser enucleation of the prostateProcedure or surgery
holimum laser enucleation of the prostate
diode laser ablation of the prostateProcedure or surgery
diode laser ablation of the prostate
| Study group | Role | What they receive |
|---|---|---|
| patient with prostate size above 80 grams for Bipolar resection | Active comparator | patient with prostate size above 80 grams Receives: Procedure: bipolar resection of the prostate |
| patient with prostate size above 80 grams for holmium laser enucleation | Active comparator | patient with prostate size above 80 grams for holmium laser enucleation Receives: Procedure: holimum laser enucleation of the prostate |
| patient with prostate size above 80 grams for Diode laser ablation | Active comparator | patient with prostate size above 80 grams for Diode laser ablation Receives: Procedure: diode laser ablation of the prostate |
What is being measured
The primary outcome is the main question the study is designed to answer.
time to catheter removal
number of days to catheter removal post-operatively
Measured: within the first 1 week post-operatively
Secondary outcomes (1)
removed prostatic tisuue
assessment of prostate size by Pelviabdominal ultrasound and wight of the removed prostatic tissues in grams
Measured: within the first month postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2026
- Study start20 Feb 2026 (estimated)
- Primary completion20 Dec 2026 (estimated)
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Benign Prostatic Hyperplasia With Outflow ObstructionStudies of the same condition, open and under way.
- More trials run by Ain Shams 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
- 105 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07410390
- Sponsor's protocol ID
- Treatment modalities for BPH
- Status last verified
- Feb 2026
- First submitted
- 16 Nov 2025
- Last updated
- 13 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All the parameters that are already mentioned in the study outcomes can be shared except for personal data of the patients (name , identification card numbers , address , phone Number)
Publications
Elshal AM, Soltan M, El-Tabey NA, Laymon M, Nabeeh A. Randomised trial of bipolar resection vs holmium laser enucleation vs Greenlight laser vapo-enucleation of the prostate for treatment of large benign prostate obstruction: 3-years outcomes. BJU Int. 2020 Dec;126(6):731-738. doi: 10.1111/bju.15161. Epub 2020 Sep 30.
PubMed 32633020Blanco Fernandez R, Gonzalez Rodriguez I, Fernandez-Pello Montes S, Sanchez Verdes P, Miranda Garcia P, Suarez Sal PJ, Alonso Calvar L, Rodriguez Villamil L. Holmium laser enucleation of the prostate (HoLEP) as same-day surgery: A safe and feasible option. Actas Urol Esp (Engl Ed). 2023 Sep;47(7):457-461. doi: 10.1016/j.acuroe.2023.05.006. Epub 2023 Jun 25. English, Spanish.
PubMed 37369301
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Study Comparing Safety, Efficacy and Short Term Outcomes Of Bipolar Prostate Resection (BPR) Versus Diode Laser Ablation Versus Holmium Laser Enucleation Of Prostate Above 80 Grams With Minimum One Year Follow Up Duration.
- ClinicalTrials.gov ID
- NCT07410390
- Acronym / sponsor ID
- Treatment modalities for BPH
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 105 participants (estimated)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 20 Feb 2026 (estimated)
- Primary completion
- 20 Dec 2026 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 13 Feb 2026 (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.
Randomized Controlled Study Comparing Safety, Efficacy and Short Term Outcomes Of Bipolar Prostate Resection (BPR) Versus Diode Laser Ablation Versus Holmium Laser Enucleation Of Prostate Above 80 Grams With Minimum One Year Follow Up Duration.
Detailed description
comparing three different techniques for treatment of prostatomegaly (BPH) bipolar resection of the prostate versus diode laser ablation of the prostate versus holmium laser enucleation monitoring preoperative data . intraoperative data , postoperative outcomes and long term outcomes within 1 year of the operation aiming to decide which technique has the superior hand over other regarding large size prostate above 80 grams
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| patient with prostate size above 80 grams for Bipolar resection | Active comparator | Procedure: bipolar resection of the prostatepatient with prostate size above 80 grams |
| patient with prostate size above 80 grams for holmium laser enucleation | Active comparator | Procedure: holimum laser enucleation of the prostatepatient with prostate size above 80 grams for holmium laser enucleation |
| patient with prostate size above 80 grams for Diode laser ablation | Active comparator | Procedure: diode laser ablation of the prostatepatient with prostate size above 80 grams for Diode laser ablation |
Who may qualify
- Ages
- 55 to 85 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Refractory LUTS secondary to benign prostatic hyperplasia (BPH)
- Acute retention secondary to BPH who failed medical treatment
- Prostate size above 80 gm in Pelvi-Abdominal ultrasound or Trans-Rectal ultrasound
Key exclusion criteria (6 listed)
- Suspected Neurogenic bladder.
- Suspected Prostatic adenocarcinoma (either by digital rectal examination or high PSA level)
- Urinary bladder carcinoma
- urethral stricture. previous bladder, urethral or prostate surgery.
- Bleeding tendency.
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 |
|---|---|---|
| bipolar resection of the prostatebipolar resection of the prostate | Procedure or surgery | patient with prostate size above 80 grams for Bipolar resection |
| holimum laser enucleation of the prostateholimum laser enucleation of the prostate | Procedure or surgery | patient with prostate size above 80 grams for holmium laser enucleation |
| diode laser ablation of the prostatediode laser ablation of the prostate | Procedure or surgery | patient with prostate size above 80 grams for Diode laser ablation |
Primary outcome
time to catheter removal
Time frame: within the first 1 week post-operatively
number of days to catheter removal post-operatively
1 secondary outcome
removed prostatic tisuue
Time frame: within the first month postoperatively
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2026.
- Results publication: PubMed 32633020Elshal AM, Soltan M, El-Tabey NA, Laymon M, Nabeeh A. Randomised trial of bipolar resection vs holmium laser enucleation vs Greenlight laser vapo-enucleation of the prostate for treatment of large benign prostate obstruction: 3-years outcomes. BJU Int. 2020 Dec;126(6):731-738. doi: 10.1111/bju.15161. Epub 2020 Sep 30.
- Results publication: PubMed 37369301Blanco Fernandez R, Gonzalez Rodriguez I, Fernandez-Pello Montes S, Sanchez Verdes P, Miranda Garcia P, Suarez Sal PJ, Alonso Calvar L, Rodriguez Villamil L. Holmium laser enucleation of the prostate (HoLEP) as same-day surgery: A safe and feasible option. Actas Urol Esp (Engl Ed). 2023 Sep;47(7):457-461. doi: 10.1016/j.acuroe.2023.05.006. Epub 2023 Jun 25. English, Spanish.
- Individual participant dataSharing planned: Yes. All the parameters that are already mentioned in the study outcomes can be shared except for personal data of the patients (name , identification card numbers , address , phone Number)
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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.
Questions about this trial
What is this clinical trial studying?
A study testing bipolar resection of the prostate, holimum laser enucleation of the prostate and diode laser ablation of the prostate in people with Benign Prostatic Hyperplasia With Outflow Obstruction, run by Ain Shams University.
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 3 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: opening soon, as of the sponsor's last update on 13 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact amr ahmed said elsawy, urology specialist (01222543421, amr.elasawy@med.asu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
time to catheter removal (time frame: within the first 1 week post-operatively). 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 NCT07410390, which also lists 2 linked publications.
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 13 Feb 2026.