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

Holmium Laser Versus Thulium Laser Versus Bipolar Enucleation of the Prostate for Treatment of Large Sized Benign Prostatic Enlargement. A Randomized Controlled Trial

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.

Study Overview

• Status: Completed
• Conditions: Prostate Hypertrophy; Holmium Laser; Thulium Laser; Bipolar Diathermy; Prostate Enucleation
• Intervention / Treatment: Procedure: Holmium Laser; Procedure: Thulium Laser; Procedure: Bipolar diathermy

• Study Type: Interventional
• Enrollment (Actual): 155
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Dakahlia
    • Mansoura, Dakahlia, Egypt, 35516
      • Urology and nephrology center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 48 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Holmium Laser; holmium laser enucleation of the prosteate	Procedure: Holmium Laser; Holmium laser enucleation of large sized prostate; Other Names: HoLEP
Active Comparator: Thulium Laser; Thulium laser enucleation of the prosteate	Procedure: Thulium Laser; Thulium laser enucleation of large sized prostate; Other Names: ThuLEP
Active Comparator: Bipolar Enucleation; Bipolar enucleation of the prosteate	Procedure: Bipolar diathermy; Bipolar enucleation of large sized prostate; Other Names: Bipolar enucleation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
urinary functional outcomes using uroflowmetry	assessed by maximum flow rate (Q-max) measured using uroflowmetry by ml/sec, better outcome above 15ml/sec	2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
patient symptoms	assessed by international prostate symptoms score (IPSS) questionnaire, better outcome score below 9	2 years
perioperative complications	assessed by clavien dindo score	2 years

Collaborators and Investigators

• Sponsor: Mansoura University

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2019
• Primary Completion (Actual): March 1, 2021
• Study Completion (Actual): March 1, 2021

Study Registration Dates

• First Submitted: April 13, 2019
• First Submitted That Met QC Criteria: April 13, 2019
• First Posted (Actual): April 16, 2019

Study Record Updates

• Last Update Posted (Actual): September 21, 2021
• Last Update Submitted That Met QC Criteria: September 18, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Keywords: Holmium Laser; prostate enucleation; Thulium Laser; Bipolar diathermy
• Additional Relevant MeSH Terms: Wounds and Injuries; Prostatic Diseases; Pathological Conditions, Anatomical; Body Temperature Changes; Heat Stress Disorders; Prostatic Hyperplasia; Hypertrophy; Hyperthermia
• Other Study ID Numbers: Prostate Enucleation

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No