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

Not Applicable

Completed

• Conditions: Holmium Laser; Prostate Hypertrophy; Bipolar Diathermy; Thulium Laser; Prostate Enucleation
• Interventions: Procedure: Thulium Laser; Procedure: Bipolar diathermy; Procedure: Holmium Laser

• Registration Number: NCT03916536
• Lead Sponsor: 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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2019-02-01
• Study First Submitted: 2019-04-13
• Study First Submitted QC: 2019-04-13
• Study First Posted: 2019-04-16
• Primary Completion: 2021-03-01
• Study Completion: 2021-03-01
• Status Verified: 2021-09
• Last Update Submitted: 2021-09-18
• Last Update Posted: 2021-09-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 155

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Thulium Laser	Thulium Laser	Thulium laser enucleation of the prosteate
Bipolar Enucleation	Bipolar diathermy	Bipolar enucleation of the prosteate
Holmium Laser	Holmium Laser	holmium laser enucleation of the prosteate

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
patient symptoms	2 years	assessed by international prostate symptoms score (IPSS) questionnaire, better outcome score below 9
perioperative complications	2 years	assessed by clavien dindo score

Trial Locations

Locations (1)

Urology and Nephrology Center; 🇪🇬 Mansoura, Dakahlia, Egypt