ThuLEP vs. HoLEP vs. Monopolar Enucleation in Management of BPH
Primary Purpose
Prostatic Hyperplasia, Benign, Prostate Adenoma, Lower Urinary Tract Symptoms
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Thulium-fiber laser enucleation of the prostate
Monopolar enucleation of the prostate
Ho:YAG laser enucleation of the prostate
Sponsored by
About this trial
This is an interventional treatment trial for Prostatic Hyperplasia, Benign focused on measuring laser, HoLEP, ThuLEP, Thulium, Thulium-fiber, BPH, EEP, monopolar enucleation
Eligibility Criteria
Inclusion Criteria:
- IPSS>20;
- maximum urinary flow rate< 10ml\s (Qmax);
- ineffective alfa-blockers therapy.
Exclusion Criteria:
- histologically verified prostate cancer;
- history of prostatic surgery;
- urethral strictures;
- bladder stones;
- chronic urinary retention and cystostomy.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Active Comparator
Arm Label
ThuLEP group
Monopolar enucleation group
HoLEP group
Arm Description
Patients who underwent thulium-fiber laser enucleation of the prostate due to lower urinary tract symptoms caused by prostatic hyperplasia.
Patients who underwent monopolar enucleation of the prostate due to lower urinary tract symptoms caused by prostatic hyperplasia.
Patients who underwent Ho:YAG laser enucleation of the prostate due to lower urinary tract symptoms caused by prostatic hyperplasia.
Outcomes
Primary Outcome Measures
IPSS
International Prostate Symptom Score
Secondary Outcome Measures
QoL
Quality of Life Score
PVR
Post-void residual volume
Qmax
Maximal urine flow rate
IIEF-5
The International Index of Erectile Function
Full Information
NCT ID
NCT03230721
First Posted
July 24, 2017
Last Updated
July 26, 2017
Sponsor
I.M. Sechenov First Moscow State Medical University
1. Study Identification
Unique Protocol Identification Number
NCT03230721
Brief Title
ThuLEP vs. HoLEP vs. Monopolar Enucleation in Management of BPH
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
Study Type
Interventional
2. Study Status
Record Verification Date
July 2017
Overall Recruitment Status
Completed
Study Start Date
January 15, 2015 (Actual)
Primary Completion Date
April 22, 2017 (Actual)
Study Completion Date
July 21, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
I.M. Sechenov First Moscow State Medical University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostatic Hyperplasia, Benign, Prostate Adenoma, Lower Urinary Tract Symptoms
Keywords
laser, HoLEP, ThuLEP, Thulium, Thulium-fiber, BPH, EEP, monopolar enucleation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
450 (Actual)
8. Arms, Groups, and Interventions
Arm Title
ThuLEP group
Arm Type
Active Comparator
Arm Description
Patients who underwent thulium-fiber laser enucleation of the prostate due to lower urinary tract symptoms caused by prostatic hyperplasia.
Arm Title
Monopolar enucleation group
Arm Type
Active Comparator
Arm Description
Patients who underwent monopolar enucleation of the prostate due to lower urinary tract symptoms caused by prostatic hyperplasia.
Arm Title
HoLEP group
Arm Type
Active Comparator
Arm Description
Patients who underwent Ho:YAG laser enucleation of the prostate due to lower urinary tract symptoms caused by prostatic hyperplasia.
Intervention Type
Procedure
Intervention Name(s)
Thulium-fiber laser enucleation of the prostate
Other Intervention Name(s)
ThuLEP
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Monopolar enucleation of the prostate
Other Intervention Name(s)
Monopolar enucleation
Intervention Description
Monopolar enucleation was performed with a high-frequency generator (50-60 Hz), a pusher-electrode, and a hook-electrode.
Intervention Type
Procedure
Intervention Name(s)
Ho:YAG laser enucleation of the prostate
Other Intervention Name(s)
HoLEP
Intervention Description
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.
Primary Outcome Measure Information:
Title
IPSS
Description
International Prostate Symptom Score
Time Frame
Six months
Secondary Outcome Measure Information:
Title
QoL
Description
Quality of Life Score
Time Frame
Six months
Title
PVR
Description
Post-void residual volume
Time Frame
Six months
Title
Qmax
Description
Maximal urine flow rate
Time Frame
Six months
Title
IIEF-5
Description
The International Index of Erectile Function
Time Frame
Six months
10. Eligibility
Sex
Male
Gender Based
Yes
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
IPSS>20;
maximum urinary flow rate< 10ml\s (Qmax);
ineffective alfa-blockers therapy.
Exclusion Criteria:
histologically verified prostate cancer;
history of prostatic surgery;
urethral strictures;
bladder stones;
chronic urinary retention and cystostomy.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dmitry Enikeev, MD, PhD
Organizational Affiliation
I.M. Sechenov First Moscow State Medical University
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
25613154
Citation
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.
Results Reference
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PubMed Identifier
24972732
Citation
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.
Results Reference
background
PubMed Identifier
28497447
Citation
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.
Results Reference
background
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ThuLEP vs. HoLEP vs. Monopolar Enucleation in Management of BPH
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