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Completed

NCT Number: NCT03998150

Holmium Laser vs Bipolar Enucleation of a Large Volume BPH: a Randomised Controlled Study

To compare bipolar plasmakinetic enucleation versus holmium laser enucleation for management of large BPH.

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Key information

Conditions

BPH With Urinary Obstruction Male

Age range

40 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Cairo University Hospitals

Cairo, 12222, Egypt

About this study

To compare safety and efficacy of bipolar plasmakinetic enucleation (BPEP) versus holmium laser enucleation (HoLEP) for management of large BPH (>80gm).

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients suffering from LUTS secondary to infravesical obstruction from BPH
  • failed medical treatment
  • International Prostate Symptom Score (IPSS) > 13
  • a peak urinary flow rate (Qmax) < 15 ml/sec
  • a prostate size ≥ 80 gm

Exclusion criteria

  • presence of a urethral stricture
  • neurological disorder
  • bladder cancer
  • prostate cancer
  • previous history of bladder neck surgery or TURP

Treatment and study plan

holmium laser enucleation of the prostate

Procedure

cystoscopic transurethral enucleation of the prostate using Holmium laser (Asclepion MultiPulse HoPlus 110W and Lumenis pulse 100W and 120W)

Other names: HoLEP

Bipolar plasma kinetic enucleation of the prostate

Procedure

cystoscopic transurethral enucleation of the prostate using bipolar plasma kinetic energy (KLS Martin Maxium or Covidien Force Triad)

Other names: BPEP

Primary outcomes

  1. hemoglobin drop postoperatively (gm/dL)

    Time frame: Immediate postoperatively

    difference in hemoglobin concentration postoperatively vs preoperatively

  2. operative time

    Time frame: during surgery

    operative time in minutes

Secondary outcomes

  1. complications (%)

    Time frame: one year

    intraoperative and postoperative complications including blood transfusion, capsular perforation, irritative symptoms, SUI, urethral stricture, bladder neck contracture, urinary retention.

  2. urine flow

    Time frame: one year

    Qmax (ml/s),

  3. post-voiding residual urine

    Time frame: one year

    postvoiding residual urine (ml)

  4. International prostate symptom score (IPSS)

    Time frame: one year

    an international commonly used score ranging from 0 - 35 (the worst is 35) evaluating voiding and storage urinary symptoms using 7 questions each one is scored from 0 to 5 according to severity of symptom

  5. Quality of life (QoL) section of International prostate symptom score (IPSS)

    Time frame: one year

    one question scored from 0 up to 6 (6 is worst)

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Collaborators

  • Theodor Bilharz Research Institute

Registry information

Official study title

Holmium Laser Enucleation Versus Bipolar Plasmakinetic Enucleation of a Large Volume Benign Prostatic Hyperplasia: a Randomised Controlled Study

Acronym: BPH

Important dates

Study start
2016
Primary completion
2018
Study completion
2019
First posted
Jun 26, 2019
Registry last updated
Jun 27, 2019

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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