Prostatic Hyperplasia, BenignNCT03230721

ThuLEP vs. HoLEP vs. Monopolar Enucleation in Management of BPH

A study testing Thulium-fiber laser enucleation of the prostate, Monopolar enucleation of the prostate and Ho:YAG laser enucleation of the prostate in people with Prostatic Hyperplasia, Benign and Prostate Adenoma, run by I.M. Sechenov First Moscow State Medical University.

Completed

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

Official record

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Trial summary

Who is it for?: Ages 50 to 90 years, men only
Conditions the study is for: Prostatic Hyperplasia, Benign, Prostate Adenoma, Lower Urinary Tract Symptoms
What is being tested?: Thulium-fiber laser enucleation of the prostate, Monopolar enucleation of the prostate and Ho:YAG laser enucleation of the prostate
Type of treatment: Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 450 participants
Where: No sites listed yet
Study dates: 15 Jan 2015to 21 Jul 2017
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 to 90 years
Men only
No healthy volunteers
Adult, Older adult

Who may be able to join

IPSS>20;
maximum urinary flow rate< 10ml\s (Qmax);
ineffective alfa-blockers therapy.

Who cannot join

histologically verified prostate cancer;
history of prostatic surgery;
urethral strictures;
bladder stones;
chronic urinary retention and cystostomy.

About this study

Official title: Comparative Analysis of the Efficacy and Safety of Thulium-fiber Laser Enucleation, Ho:YAG Laser Enucleation and Monopolar Enucleation in Management of BPH

Today, endoscopic enucleation of the prostate (EEP) has been recognized a method of choice for treatment of benign prostatic hyperplasia (BPH) of any size, including large-sized glands (>80 cc). The goal of our study was to compare perioperative efficacy, functional outcomes and safety of different techniques of endoscopic enucleation of the prostate (monopolar enucleation, holmium laser enucleation, thulium laser enucleation) in a single center.

Read the detailed description

HoLEP and ThuLEP or EEP have been approved by the current guidelines of the European Association of Urology for use in men with substantially enlarged prostates (>80 ml) as first-line therapy [1]. This type of operation can be performed by means of several sources of energy.

To our knowledge, there were no studies comparing efficacy and complications of these three treatment modalities.

In this study the investigators have evaluated efficacy of Thulium-fiber laser enucleation (120 W thulium fiber laser Urolase, IPG IRE-POLUS, Russia with wavelength of 1940 nm) and monopolar enuclation in comparision with HoLEP (VersaPulse Powersuite 100, Lumenis, USA/Israel) in reduction of LUTS secondary to BPH in a prospective randomized trial.

All peri-operative parameters, urinary flow parameters, prostate size changes, erectile function and complications associated with the procedures were compared.

Conditions: Prostatic Hyperplasia, Benign, Prostate Adenoma, Lower Urinary Tract Symptoms
Being tested: Thulium-fiber laser enucleation of the prostate, Monopolar enucleation of the prostate, Ho:YAG laser enucleation of the prostate
Keywords: laser, HoLEP, ThuLEP, Thulium, Thulium-fiber, BPH, EEP, monopolar enucleation
Medical subject headings: Prostatic Hyperplasia, Lower Urinary Tract Symptoms

What participants receive

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

Thulium-fiber laser enucleation of the prostateProcedure or surgery
Also called ThuLEP
A high-power (120 W) thulium fiber laser (Urolase, IPG IRE-POLUS, Russia) with wavelength of 1940 nm was used for thulium laser enucleation. In our study, we used a 600-μm laser fiber. The operations were performed at power of 60 W energy of 1.5 J and repetition rate of 40 Hz. Laser power in the verumontanum zone was decreased to 30 W and repetition rate to 20 Hz.
Monopolar enucleation of the prostateProcedure or surgery
Also called Monopolar enucleation
Monopolar enucleation was performed with a high-frequency generator (50-60 Hz), a pusher-electrode, and a hook-electrode.
Ho:YAG laser enucleation of the prostateProcedure or surgery
Also called HoLEP
Holmium laser enucleation of prostatic hyperplasia was performed with a 100 W laser (VersaPulse Powersuite 100, Lumenis, USA/Israel) with wavelength of 2100 nm and 550-μm fiber at the tip. The operation was performed at power of 70 W; it was decreased to 40 W when incisions were made at the verumontanum.

Study groups in NCT03230721
Study group	Role	What they receive
ThuLEP group	Active comparator	Patients who underwent thulium-fiber laser enucleation of the prostate due to lower urinary tract symptoms caused by prostatic hyperplasia. Receives: Procedure: Thulium-fiber laser enucleation of the prostate
Monopolar enucleation group	Active comparator	Patients who underwent monopolar enucleation of the prostate due to lower urinary tract symptoms caused by prostatic hyperplasia. Receives: Procedure: Monopolar enucleation of the prostate
HoLEP group	Active comparator	Patients who underwent Ho:YAG laser enucleation of the prostate due to lower urinary tract symptoms caused by prostatic hyperplasia. Receives: Procedure: Ho:YAG laser enucleation of the prostate

What is being measured

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

IPSS
International Prostate Symptom Score
Measured: Six months

Secondary outcomes (4)

QoL
Quality of Life Score
Measured: Six months
PVR
Post-void residual volume
Measured: Six months
Qmax
Maximal urine flow rate
Measured: Six months
IIEF-5
The International Index of Erectile Function
Measured: Six months

Timeline

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

15 Jan 201521 Jul 2017

First posted26 Jul 2017
Study start15 Jan 2015
Primary completion22 Apr 2017
Study completion21 Jul 2017

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (3)Papers the sponsor has linked to this study.
Other trials for Prostatic Hyperplasia, BenignStudies of the same condition, open and under way.
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: 450 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03230721
Sponsor's protocol ID: IMSechenovMMA
Status last verified: Jul 2017
First submitted: 24 Jul 2017
Last updated: 28 Jul 2017
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Gratzke C, Bachmann A, Descazeaud A, Drake MJ, Madersbacher S, Mamoulakis C, Oelke M, Tikkinen KAO, Gravas S. EAU Guidelines on the Assessment of Non-neurogenic Male Lower Urinary Tract Symptoms including Benign Prostatic Obstruction. Eur Urol. 2015 Jun;67(6):1099-1109. doi: 10.1016/j.eururo.2014.12.038. Epub 2015 Jan 19.
PubMed 25613154
Cornu JN, Ahyai S, Bachmann A, de la Rosette J, Gilling P, Gratzke C, McVary K, Novara G, Woo H, Madersbacher S. A Systematic Review and Meta-analysis of Functional Outcomes and Complications Following Transurethral Procedures for Lower Urinary Tract Symptoms Resulting from Benign Prostatic Obstruction: An Update. Eur Urol. 2015 Jun;67(6):1066-1096. doi: 10.1016/j.eururo.2014.06.017. Epub 2014 Jun 25.
PubMed 24972732
Glybochko PV, Rapoport LM, Enikeev ME, Enikeev DV. Holmium laser enucleation of the prostate (HoLEP) for small, large and giant prostatic hyperplasia: tips and tricks. Urologia. 2017 Aug 1;84(3):169-173. doi: 10.5301/uj.5000232. Epub 2017 May 10.
PubMed 28497447

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?

Official record

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
BPH With Symptomatic Lower Urinary Tract Symptoms
Recruiting
Learning Curve of Tri-lobar HoLEP Versus En-bloc HoLEP
Benign Prostatic Hyperplasia With Outflow Obstruction
RecruitingObservational study
Impact of Long-term Dutasteride Use on Perioperative Outcomes of HoLEP
Prostatic Hyperplasia, Benign

All Prostatic Hyperplasia, Benign trials

Study at a glance

From the registry record, last updated by the sponsor on 28 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Comparative Analysis of the Efficacy and Safety of Thulium-fiber Laser Enucleation, Ho:YAG Laser Enucleation and Monopolar Enucleation in Management of BPH
ClinicalTrials.gov ID: NCT03230721
Acronym / sponsor ID: IMSechenovMMA
Conditions: Prostatic Hyperplasia, Benign, Prostate Adenoma, Lower Urinary Tract Symptoms
Keywords: laser, HoLEP, ThuLEP, Thulium, Thulium-fiber, BPH, EEP, monopolar enucleation
Study type: Interventional
Recruitment status: Completed
Enrolment: 450 participants (actual)
Lead sponsor: I.M. Sechenov First Moscow State Medical UniversityUniversity, hospital or other
Study start: 15 Jan 2015 (actual)
Primary completion: 22 Apr 2017 (actual)
Study completion: 21 Jul 2017 (actual)
First posted: 26 Jul 2017 (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.

Detailed description

To our knowledge, there were no studies comparing efficacy and complications of these three treatment modalities.

All peri-operative parameters, urinary flow parameters, prostate size changes, erectile function and complications associated with the procedures were compared.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 3

Arm	Type	Receives
ThuLEP group	Active comparator	Procedure: Thulium-fiber laser enucleation of the prostatePatients who underwent thulium-fiber laser enucleation of the prostate due to lower urinary tract symptoms caused by prostatic hyperplasia.
Monopolar enucleation group	Active comparator	Procedure: Monopolar enucleation of the prostatePatients who underwent monopolar enucleation of the prostate due to lower urinary tract symptoms caused by prostatic hyperplasia.
HoLEP group	Active comparator	Procedure: Ho:YAG laser enucleation of the prostatePatients who underwent Ho:YAG laser enucleation of the prostate due to lower urinary tract symptoms caused by prostatic hyperplasia.

Who may qualify

Ages: 50 to 90 years
Sex: Male only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

IPSS>20;
maximum urinary flow rate< 10ml\s (Qmax);
ineffective alfa-blockers therapy.

Key exclusion criteria (5 listed)

histologically verified prostate cancer;
history of prostatic surgery;
urethral strictures;
bladder stones;
chronic urinary retention and cystostomy.

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-fiber laser enucleation of the prostateAlso: ThuLEPA high-power (120 W) thulium fiber laser (Urolase, IPG IRE-POLUS, Russia) with wavelength of 1940 nm was used for thulium laser enucleation. In our study, we used a 600-μm laser fiber. The operations were performed at power of 60 W energy of 1.5 J and repetition rate of 40 Hz. Laser power in the verumontanum zone was decreased to 30 W and repetition rate to 20 Hz.	Procedure or surgery	ThuLEP group
Monopolar enucleation of the prostateAlso: Monopolar enucleationMonopolar enucleation was performed with a high-frequency generator (50-60 Hz), a pusher-electrode, and a hook-electrode.	Procedure or surgery	Monopolar enucleation group
Ho:YAG laser enucleation of the prostateAlso: HoLEPHolmium laser enucleation of prostatic hyperplasia was performed with a 100 W laser (VersaPulse Powersuite 100, Lumenis, USA/Israel) with wavelength of 2100 nm and 550-μm fiber at the tip. The operation was performed at power of 70 W; it was decreased to 40 W when incisions were made at the verumontanum.	Procedure or surgery	HoLEP group

Primary outcome

IPSS
Time frame: Six months
International Prostate Symptom Score

4 secondary outcomes

QoL
Time frame: Six months
PVR
Time frame: Six months
Qmax
Time frame: Six months
IIEF-5
Time frame: Six months

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 28 Jul 2017.
Background: PubMed 25613154Gratzke C, Bachmann A, Descazeaud A, Drake MJ, Madersbacher S, Mamoulakis C, Oelke M, Tikkinen KAO, Gravas S. EAU Guidelines on the Assessment of Non-neurogenic Male Lower Urinary Tract Symptoms including Benign Prostatic Obstruction. Eur Urol. 2015 Jun;67(6):1099-1109. doi: 10.1016/j.eururo.2014.12.038. Epub 2015 Jan 19.
Background: PubMed 24972732Cornu JN, Ahyai S, Bachmann A, de la Rosette J, Gilling P, Gratzke C, McVary K, Novara G, Woo H, Madersbacher S. A Systematic Review and Meta-analysis of Functional Outcomes and Complications Following Transurethral Procedures for Lower Urinary Tract Symptoms Resulting from Benign Prostatic Obstruction: An Update. Eur Urol. 2015 Jun;67(6):1066-1096. doi: 10.1016/j.eururo.2014.06.017. Epub 2014 Jun 25.
Background: PubMed 28497447Glybochko PV, Rapoport LM, Enikeev ME, Enikeev DV. Holmium laser enucleation of the prostate (HoLEP) for small, large and giant prostatic hyperplasia: tips and tricks. Urologia. 2017 Aug 1;84(3):169-173. doi: 10.5301/uj.5000232. Epub 2017 May 10.
Individual participant dataSharing planned: No

Related trials for Prostatic Hyperplasia, Benign

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
BPH With Symptomatic Lower Urinary Tract Symptoms
Recruiting
Learning Curve of Tri-lobar HoLEP Versus En-bloc HoLEP
Benign Prostatic Hyperplasia With Outflow Obstruction
RecruitingObservational study
Impact of Long-term Dutasteride Use on Perioperative Outcomes of HoLEP
Prostatic Hyperplasia, Benign

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.

Dmitry Enikeev, MD, PhD principal investigator

I.M. Sechenov First Moscow State Medical University

Questions about this trial

What is this clinical trial studying?

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 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 28 Jul 2017. 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?

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?

IPSS (time frame: Six months). 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 NCT03230721, which also lists 3 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 28 Jul 2017.