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Holmium Laser Versus Thulium Laser Versus Bipolar Enucleation of the Prostate.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03916536
Recruitment Status : Recruiting
First Posted : April 16, 2019
Last Update Posted : January 14, 2020
Sponsor:
Information provided by (Responsible Party):
Fady kamal Ghobrial, Mansoura University

Brief Summary:
Because of the diversity of the studies and deficiency of those comparing various techniques of EEP for treatment of LUTs secondary to BPO in patients with large sized prostate, we aim in this study at testing the non-inferiority of PKEP and ThuLEP to HoLEP in relieving LUTs secondary to BPO in patients prostate size >80ml. Our hypothesis is to present an evidence that enucleation is a technique rather than a power dependent procedure through a RCT.

Condition or disease Intervention/treatment Phase
Prostate Hypertrophy Holmium Laser Thulium Laser Bipolar Diathermy Prostate Enucleation Procedure: Holmium Laser Procedure: Thulium Laser Procedure: Bipolar diathermy Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Holmium Laser Versus Thulium Laser Versus Bipolar Enucleation of the Prostate for Treatment of Large Sized Benign Prostatic Enlargement. A Randomized Controlled Trial
Actual Study Start Date : February 1, 2019
Estimated Primary Completion Date : February 1, 2021
Estimated Study Completion Date : February 1, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Holmium Laser
holmium laser enucleation of the prosteate
Procedure: Holmium Laser
Holmium laser enucleation of large sized prostate
Other Name: HoLEP

Active Comparator: Thulium Laser
Thulium laser enucleation of the prosteate
Procedure: Thulium Laser
Thulium laser enucleation of large sized prostate
Other Name: ThuLEP

Active Comparator: Bipolar Enucleation
Bipolar enucleation of the prosteate
Procedure: Bipolar diathermy
Bipolar enucleation of large sized prostate
Other Name: Bipolar enucleation




Primary Outcome Measures :
  1. urinary functional outcomes using uroflowmetry [ Time Frame: 2 years ]
    assessed by maximum flow rate (Q-max) measured using uroflowmetry by ml/sec, better outcome above 15ml/sec


Secondary Outcome Measures :
  1. patient symptoms [ Time Frame: 2 years ]
    assessed by international prostate symptoms score (IPSS) questionnaire, better outcome score below 9

  2. perioperative complications [ Time Frame: 2 years ]
    assessed by clavien dindo score



Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Gender Based Eligibility:   Yes
Gender Eligibility Description:   male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients' age >50 years
  • Lower urinary tract symptoms LUTS secondary benigh prostatic obstruction BPO who failed medical treatment
  • International prostate symptom scores (IPSS) >15 and bother score quality of life (QOL) > 3 (according to IPSS question 8)
  • Maximum urinary flow rate (Q max) <15 ml/sec with at least 150 ml voided volume or cases with acute urine retention secondary to BPO who failed trial of voiding on medical treatment.
  • Transrectal ultrasound TRUS estimated total prostate size 80-250cc

Exclusion Criteria:

  • Patient with neurological disorder which might affect bladder function as cerebrovascular stroke, Parkinson disease
  • Active urinary tract infection (positive urine culture) till treatment
  • Presence of bladder cancer (within the last 2 years)
  • Known prostate cancer patients will be excluded preoperatively on the basis of digital rectal examination, prostate specific antigen level, and TRUS imaging followed by prostate biopsies if necessary.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03916536


Contacts
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Contact: Fady Ghobrial, Msc 00201024974979 dr_fadykamal@yahoo.com

Locations
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Egypt
Urology and Nephrology Center Recruiting
Mansoura, Dakahlia, Egypt, 35516
Contact: Ahmed Shoma, MD       ahmedshoma@hotmail.com   
Sponsors and Collaborators
Mansoura University
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Responsible Party: Fady kamal Ghobrial, principal investigator, Mansoura University
ClinicalTrials.gov Identifier: NCT03916536    
Other Study ID Numbers: Prostate Enucleation
First Posted: April 16, 2019    Key Record Dates
Last Update Posted: January 14, 2020
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Fady kamal Ghobrial, Mansoura University:
Holmium Laser
Thulium Laser
Bipolar diathermy
prostate enucleation
Additional relevant MeSH terms:
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Prostatic Hyperplasia
Hypertrophy
Pathological Conditions, Anatomical
Prostatic Diseases