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Completed

NCT Number: NCT03916536

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

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.

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Key information

Conditions

Prostate Hypertrophy Bipolar Diathermy Genital Diseases Genital Diseases, Male Holmium Laser Male Urogenital Diseases Prostate Enucleation Prostatic Diseases Prostatic Hyperplasia Thulium Laser Urogenital Diseases

Age range

50 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Urology and Nephrology Center

Al Mansurah, Dakahlia Governorate, 35516, Egypt

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Holmium Laser

Procedure

Holmium laser enucleation of large sized prostate

Other names: HoLEP

Thulium Laser

Procedure

Thulium laser enucleation of large sized prostate

Other names: ThuLEP

bipolar diathermy

Procedure

Bipolar enucleation of large sized prostate

Other names: Bipolar enucleation

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Mansoura University

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Apr 16, 2019
Registry last updated
Sep 21, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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