Benign Prostatic HyperplasiaNCT05200065

Thulium Laser Versus Bipolar Enucleation of the Prostate

A study testing Thulium laser enucleation of the prostate and Bipolar enucleation of the prostate in people with Benign Prostatic Hyperplasia, run by Cairo University at 1 site in Egypt.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Comparing the peri-operative outcomes in patients with benign prostatic hyperplasia (BPH) who will undergo bipolar enucleation of the prostate versus thulium laser enucleation. Read more about this study

Who is it for?: Any age, men onlyHealthy volunteers can take part
Conditions the study is for: Benign Prostatic Hyperplasia
What is being tested?: Thulium laser enucleation of the prostate and Bipolar enucleation of the prostate
Type of treatment: Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 60 participants
Where: 1 siteEgypt
Study dates: 1 Jan 2021to 31 Dec 2022
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 Any age
Men only
Healthy volunteers accepted
Child, Adult, Older adult

Who may be able to join

Patients with BPH who are unsatisfied with medical treatment having a Qmax of less than 15 cm/s.
Patients with BPH who had refractory retention.
Patients with complicated BPH (eg; chronic retention, refractory hematuria, bladder stones).
Prostate size of at least 80 grams or more.

Who cannot join

Patients with a bladder mass.
Patients with prostate cancer.
Patients suffering from a urethral stricture.
Patients with previous endoscopic or surgical prostate intervention.
Prostate size less than 80 grams.

Trial locations and contacts

1 site in 1 country.

Egypt1 site

Kasr AlAiny School of Medicine
Cairo, Cairo Governorate, 11562

Other trials in Egypt

About this study

Official title: Prospective Randomized Study Comparing the Intra-operative and Post-operative Outcomes of Bipolar Enucleation of the Prostate Versus Thulium Laser Enucleation

Comparing the peri-operative outcomes in patients with benign prostatic hyperplasia (BPH) who will undergo bipolar enucleation of the prostate versus thulium laser enucleation.

Read the detailed description

Benign prostatic hyperplasia (BPH) is one of the most common and bothersome diseases influencing the quality of life of aging males. For decades, transurethral resection of the prostate (TURP) has been recognized as the standard treatment for BPH .Recently, endoscopic laser treatments of BPH has been developed as the result of advances in laser technology and better understanding of tissue-laser interactions and nowadays it represents a challenge for TURP as regards the peri-operative outcomes.
Both the European Association of Urology (EAU) and American Urological Association (AUA) recommend endoscopic enucleation of the prostate (EEP) as one of the techniques for management of benign prostatic hyperplasia (BPH) with various techniques that could be implemented including enbloc and three/two lobe enucleation.
The classical laser enucleation technique consists of a three-lobe enucleation of the adenoma with separate enucleation of the median and lateral lobes. Scoffone and Cracco developed an "en-bloc" enucleation technique for HoLEP (holmium laser enucleation) in 2016, showing a potential role to ease some difficult intraoperative steps of enucleation and to improve the learning curve and both of the techniques mentioned were found to be applicable for bipolar endoscopic enucleation as well.
Regarding the thulium laser physical properties; its wavelength is very close to the peak for absorption in water about 1940 nm being similar to the holmium laser wavelength which is about 2010 nm. However, unlike the pulsed wave holmium laser, this high density energy of thulium laser is best delivered in a continuous wave. This is translated into more efficient vaporization and shallower depth of penetration in tissue, which has been reported to be 0.2 mm as compared with 0.4 mm for holmium lasers. In thulium laser; the continuous wave mode is more suitable for hemostasis and coagulation of tissue, whereas the pulsed mode is more suited for lithotripsy.
BipolEP (Bipolar enucleation of the prostate) has been performed as an effective method for the management of BPH in some institutions. Bipolar enucleation of prostate is a done using energy source of a bipolar electrosurgical unit. Enucleated prostatic tissues are then removed with a morcellator.

Conditions: Benign Prostatic Hyperplasia
Being tested: Thulium laser enucleation of the prostate, Bipolar enucleation of the prostate
Keywords: Benign Prostatic Hyperplasia, Thulium laser enucleation, Bipolar enucleation, Anatomic enucleation of the prostate, Endoscopic Enucleation of the prostate, Thulium laser, Bipolar Plasma energy
Medical subject headings: Prostatic Hyperplasia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Thulium laser enucleation of the prostateProcedure or surgery
Using the thulium laser to achieve complete endoscopic enucleation of the prostate.
Bipolar enucleation of the prostateProcedure or surgery
Using the bipolar plasma energy to achieve complete endoscopic enucleation of the prostate.

Study groups in NCT05200065
Study group	Role	What they receive
Thulium Laser Enucleation	Experimental	Patients in this arm will undergo thulium laser enucleation of the prostate. Receives: Procedure: Thulium laser enucleation of the prostate
Bipolar Enucleation	Experimental	Patients in this arm will undergo bipolar enucleation of the prostate. Receives: Procedure: Bipolar enucleation of the prostate

What is being measured

The primary outcome is the main question the study is designed to answer.

Effect on the operative time and other intra-operative and post-operative parameters
Effect of the chosen technique on the operative time including both enucleation and morcellation times.
The occurrence of any inta-operative complications including significant blood loss necessitating blood transfusion, capsular perforation, sub-trigonal dissection and complications related to morcellation for example bladder perforation.
The occurrence of any post-operative complications which is divided into either immediate post-operative and long term complications.
Immediate post-operative complications occurring in the first 48 hours after enucleation include affection of the hemodynamics and vital signs of the patient, drop in hemoglobin level, high grade fever or uro-sepsis, retention with re-catheterization, hematuria with clot retention.
long term complications occurring include persistent urge or stress urinary incontinence, secondary hemorrhage with hematuria and clot retention, recurrent urinary tract infections, urethral stricture or bladder neck contracture.
Measured: 3 to 6 month

Secondary outcomes (3)

Change of the urine flow of the patients.
Improvement of the uroflowmetry parameters after catheter removal especially the Qmax (maximum flow rate), Qavg (Average flow rate) in addition to a bell shaped curve in the flowmetry plotted curve.
Measured: 3 to 6 month
Change of the IPSS (International Prostatic Symptom Score) of the patients
Improvement of the IPSS score of the patients after catheter removal compared to the value of the IPSS before enucleation.
Values of the IPSS:
Mild Symptoms from 1 to 7 Moderate Symptoms from 8 to 19 Severe Symptoms from 20 to 35
Measured: 3 to 6 month
Change of residual urine volume after surgery
Reduction in the amount of residual urine by US after catheter removal below 150 cc.
Measured: 3 to 6 month

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Jan 202131 Dec 2022

First posted20 Jan 2022
Study start1 Jan 2021
Primary completion1 Nov 2022
Study completion31 Dec 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (7)Papers the sponsor has linked to this study.
Other trials for Benign Prostatic HyperplasiaStudies 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
Model description: Prospective randomized study comparing two techniques of endoscopic enucleation of the prostate.
Masking: Single blind
Who is masked: Participant
Enrolment: 60 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05200065
Sponsor's protocol ID: Enucleation techniques for BPH
Status last verified: Jan 2022
First submitted: 14 Dec 2021
Last updated: 23 Jun 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

Publications

Berry SJ, Coffey DS, Walsh PC, Ewing LL. The development of human benign prostatic hyperplasia with age. J Urol. 1984 Sep;132(3):474-9. doi: 10.1016/s0022-5347(17)49698-4.
PubMed 6206240
Gravas S, Bachmann A, Reich O, Roehrborn CG, Gilling PJ, De La Rosette J. Critical review of lasers in benign prostatic hyperplasia (BPH). BJU Int. 2011 Apr;107(7):1030-43. doi: 10.1111/j.1464-410X.2010.09954.x.
PubMed 21438974
Enikeev D, Glybochko P, Okhunov Z, Alyaev Y, Rapoport L, Tsarichenko D, Enikeev M, Sorokin N, Dymov A, Taratkin M. Retrospective Analysis of Short-Term Outcomes After Monopolar Versus Laser Endoscopic Enucleation of the Prostate: A Single Center Experience. J Endourol. 2018 May;32(5):417-423. doi: 10.1089/end.2017.0898. Epub 2018 Mar 13.
PubMed 29430969
Scoffone CM, Cracco CM. The en-bloc no-touch holmium laser enucleation of the prostate (HoLEP) technique. World J Urol. 2016 Aug;34(8):1175-81. doi: 10.1007/s00345-015-1741-y. Epub 2015 Dec 11.
PubMed 26658753
Fried NM, Murray KE. High-power thulium fiber laser ablation of urinary tissues at 1.94 microm. J Endourol. 2005 Jan-Feb;19(1):25-31. doi: 10.1089/end.2005.19.25.
PubMed 15735378
Hardy LA, Wilson CR, Irby PB, Fried NM. Thulium fiber laser lithotripsy in an in vitro ureter model. J Biomed Opt. 2014 Dec;19(12):128001. doi: 10.1117/1.JBO.19.12.128001.
PubMed 25518001
Ryang SH, Ly TH, Tran AV, Oh SJ, Cho SY. Bipolar enucleation of the prostate-step by step. Andrologia. 2020 Sep;52(8):e13631. doi: 10.1111/and.13631. Epub 2020 May 22.
PubMed 32441397

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Recruiting
Clinical Study on Prostate Thermal Vapor Ablation Guided by MRI/TRUS Fusion Imaging
Benign Prostatic Hyperplasia (BPH)
Active, not recruitingPhase 4
Standard Versus Double Alpha Blockers Treatment for Symptomatic Benign Prostatic Obstruction
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RecruitingObservational study
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Recruiting
Learning Curve of Tri-lobar HoLEP Versus En-bloc HoLEP
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All Benign Prostatic Hyperplasia trials

Study at a glance

From the registry record, last updated by the sponsor on 23 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Prospective Randomized Study Comparing the Intra-operative and Post-operative Outcomes of Bipolar Enucleation of the Prostate Versus Thulium Laser Enucleation
ClinicalTrials.gov ID: NCT05200065
Acronym / sponsor ID: Enucleation techniques for BPH
Conditions: Benign Prostatic Hyperplasia
Keywords: Benign Prostatic Hyperplasia, Thulium laser enucleation, Bipolar enucleation, Anatomic enucleation of the prostate, Endoscopic Enucleation of the prostate, Thulium laser, Bipolar Plasma energy
Study type: Interventional
Recruitment status: Completed
Enrolment: 60 participants (actual)
Lead sponsor: Cairo UniversityUniversity, hospital or other
Study start: 1 Jan 2021 (actual)
Primary completion: 1 Nov 2022 (actual)
Study completion: 31 Dec 2022 (actual)
First posted: 20 Jan 2022 (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.

Comparing the peri-operative outcomes in patients with benign prostatic hyperplasia (BPH) who will undergo bipolar enucleation of the prostate versus thulium laser enucleation.

Detailed description

Benign prostatic hyperplasia (BPH) is one of the most common and bothersome diseases influencing the quality of life of aging males. For decades, transurethral resection of the prostate (TURP) has been recognized as the standard treatment for BPH .Recently, endoscopic laser treatments of BPH has been developed as the result of advances in laser technology and better understanding of tissue-laser interactions and nowadays it represents a challenge for TURP as regards the peri-operative outcomes.
Both the European Association of Urology (EAU) and American Urological Association (AUA) recommend endoscopic enucleation of the prostate (EEP) as one of the techniques for management of benign prostatic hyperplasia (BPH) with various techniques that could be implemented including enbloc and three/two lobe enucleation.
The classical laser enucleation technique consists of a three-lobe enucleation of the adenoma with separate enucleation of the median and lateral lobes. Scoffone and Cracco developed an "en-bloc" enucleation technique for HoLEP (holmium laser enucleation) in 2016, showing a potential role to ease some difficult intraoperative steps of enucleation and to improve the learning curve and both of the techniques mentioned were found to be applicable for bipolar endoscopic enucleation as well.
Regarding the thulium laser physical properties; its wavelength is very close to the peak for absorption in water about 1940 nm being similar to the holmium laser wavelength which is about 2010 nm. However, unlike the pulsed wave holmium laser, this high density energy of thulium laser is best delivered in a continuous wave. This is translated into more efficient vaporization and shallower depth of penetration in tissue, which has been reported to be 0.2 mm as compared with 0.4 mm for holmium lasers. In thulium laser; the continuous wave mode is more suitable for hemostasis and coagulation of tissue, whereas the pulsed mode is more suited for lithotripsy.
BipolEP (Bipolar enucleation of the prostate) has been performed as an effective method for the management of BPH in some institutions. Bipolar enucleation of prostate is a done using energy source of a bipolar electrosurgical unit. Enucleated prostatic tissues are then removed with a morcellator.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (participant)
Number of arms: 2
Model description: Prospective randomized study comparing two techniques of endoscopic enucleation of the prostate.

Arm	Type	Receives
Thulium Laser Enucleation	Experimental	Procedure: Thulium laser enucleation of the prostatePatients in this arm will undergo thulium laser enucleation of the prostate.
Bipolar Enucleation	Experimental	Procedure: Bipolar enucleation of the prostatePatients in this arm will undergo bipolar enucleation of the prostate.

Who may qualify

Sex: Male only
Healthy volunteers: Accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (4 listed)

Patients with BPH who are unsatisfied with medical treatment having a Qmax of less than 15 cm/s.
Patients with BPH who had refractory retention.
Patients with complicated BPH (eg; chronic retention, refractory hematuria, bladder stones).
Prostate size of at least 80 grams or more.

Key exclusion criteria (5 listed)

Patients with a bladder mass.
Patients with prostate cancer.
Patients suffering from a urethral stricture.
Patients with previous endoscopic or surgical prostate intervention.
Prostate size less than 80 grams.

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
Thulium laser enucleation of the prostateUsing the thulium laser to achieve complete endoscopic enucleation of the prostate.	Procedure or surgery	Thulium Laser Enucleation
Bipolar enucleation of the prostateUsing the bipolar plasma energy to achieve complete endoscopic enucleation of the prostate.	Procedure or surgery	Bipolar Enucleation

Primary outcome

Effect on the operative time and other intra-operative and post-operative parameters
Time frame: 3 to 6 month
Effect of the chosen technique on the operative time including both enucleation and morcellation times. The occurrence of any inta-operative complications including significant blood loss necessitating blood transfusion, capsular perforation, sub-trigonal dissection and complications related to morcellation for example bladder perforation. The occurrence of any post-operative complications which is divided into either immediate post-operative and long term complications. Immediate post-operative complications occurring in the first 48 hours after enucleation include affection of the hemodynamics and vital signs of the patient, drop in hemoglobin level, high grade fever or uro-sepsis, retention with re-catheterization, hematuria with clot retention. long term complications occurring include persistent urge or stress urinary incontinence, secondary hemorrhage with hematuria and clot retention, recurrent urinary tract infections, urethral stricture or bladder neck contracture.

3 secondary outcomes

Change of the urine flow of the patients.
Time frame: 3 to 6 month
Change of the IPSS (International Prostatic Symptom Score) of the patients
Time frame: 3 to 6 month
Change of residual urine volume after surgery
Time frame: 3 to 6 month

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 23 Jun 2026.
Background: PubMed 6206240Berry SJ, Coffey DS, Walsh PC, Ewing LL. The development of human benign prostatic hyperplasia with age. J Urol. 1984 Sep;132(3):474-9. doi: 10.1016/s0022-5347(17)49698-4.
Background: PubMed 21438974Gravas S, Bachmann A, Reich O, Roehrborn CG, Gilling PJ, De La Rosette J. Critical review of lasers in benign prostatic hyperplasia (BPH). BJU Int. 2011 Apr;107(7):1030-43. doi: 10.1111/j.1464-410X.2010.09954.x.
Background: PubMed 29430969Enikeev D, Glybochko P, Okhunov Z, Alyaev Y, Rapoport L, Tsarichenko D, Enikeev M, Sorokin N, Dymov A, Taratkin M. Retrospective Analysis of Short-Term Outcomes After Monopolar Versus Laser Endoscopic Enucleation of the Prostate: A Single Center Experience. J Endourol. 2018 May;32(5):417-423. doi: 10.1089/end.2017.0898. Epub 2018 Mar 13.
Background: PubMed 26658753Scoffone CM, Cracco CM. The en-bloc no-touch holmium laser enucleation of the prostate (HoLEP) technique. World J Urol. 2016 Aug;34(8):1175-81. doi: 10.1007/s00345-015-1741-y. Epub 2015 Dec 11.
Background: PubMed 15735378Fried NM, Murray KE. High-power thulium fiber laser ablation of urinary tissues at 1.94 microm. J Endourol. 2005 Jan-Feb;19(1):25-31. doi: 10.1089/end.2005.19.25.
Background: PubMed 25518001Hardy LA, Wilson CR, Irby PB, Fried NM. Thulium fiber laser lithotripsy in an in vitro ureter model. J Biomed Opt. 2014 Dec;19(12):128001. doi: 10.1117/1.JBO.19.12.128001.
Background: PubMed 32441397Ryang SH, Ly TH, Tran AV, Oh SJ, Cho SY. Bipolar enucleation of the prostate-step by step. Andrologia. 2020 Sep;52(8):e13631. doi: 10.1111/and.13631. Epub 2020 May 22.

Related trials for Benign Prostatic Hyperplasia

Recruiting
Clinical Study on Prostate Thermal Vapor Ablation Guided by MRI/TRUS Fusion Imaging
Benign Prostatic Hyperplasia (BPH)
Active, not recruitingPhase 4
Standard Versus Double Alpha Blockers Treatment for Symptomatic Benign Prostatic Obstruction
BPH (Benign Prostatic Hyperplasia)
RecruitingObservational study
ProVIDE Studies Post Exit Analysis
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Recruiting
Learning Curve of Tri-lobar HoLEP Versus En-bloc HoLEP
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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.

Omar AbdelRazzak, MD Urology study director

Kasr AlAiny

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Thulium laser enucleation of the prostate and Bipolar enucleation of the prostate in people with Benign Prostatic Hyperplasia, 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 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 23 Jun 2026. 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?

Effect on the operative time and other intra-operative and post-operative parameters (time frame: 3 to 6 month). 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 NCT05200065, which also lists 7 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 23 Jun 2026.