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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
I.M. Sechenov First Moscow State Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

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

50 Years - 90 Years (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

    First Posted
    July 24, 2017
    Last Updated
    July 26, 2017
    Sponsor
    I.M. Sechenov First Moscow State Medical University
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    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
    background
    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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