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Completed

NCT Number: NCT04935151

HoLEP vs BPRP in the Management of a Large Volume (> 80 gm) Symptomatic BPH

To compare bipolar resection versus holmium laser enucleation for management of symptomatic large BPH (> 80 gm)

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Key information

Conditions

BPH With Urinary Obstruction Male

Age range

45 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Cairo University Hospitals, Cairo, Egypt

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About this study

To compare safety and efficacy of bipolar resection (BPRP) versus holmium laser enucleation (HoLEP) for management of symptomatic large BPH (> 80 gm)

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 with 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

Other names: HoLEP

bipolar resection of the prostate

Procedure

cystoscopic transurethral resection of the prostate using bipolar energy

Other names: BPRP

Primary outcomes

  1. hemoglobin drop postoperatively (gm/dL)

    Time frame: within two hours after surgery

    change in hemoglobin concentration postoperatively vs preoperatively

Secondary outcomes

  1. operative duration in minutes

    Time frame: Time lapsed during surgery

    operative duration

  2. Hospital stay

    Time frame: From time of randomisation up to last day of admission in hospital (in days) up to 30 days

    Hospitalisation starting from day of surgery till the day of discharge from Hospital in days

  3. blood transfusion

    Time frame: during surgery and hospitalisation up to 10 days

    rate of blood transfusion

Other outcomes

  1. complications (percent)

    Time frame: Three years

    All complications

  2. International prostate symptom score (IPSS)

    Time frame: Three years

    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

  3. Quality of life (QoL)

    Time frame: Three years

    section of International prostate symptom score (IPSS) one question scored from 0 up to 6 (6 is worst)

  4. flowmetry

    Time frame: Three years

    rate of flow (ml urine) per second

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Collaborators

  • Theodor Bilharz Research Institute

Registry information

Official study title

Holmium Laser Enucleation Versus Bipolar Resection in the Management of a Large Volume (> 80 gm) Symptomatic BPH: a Randomised Controlled Trial

Important dates

Study start
2016
Primary completion
2018
Study completion
2021
First posted
Jun 22, 2021
Registry last updated
Jun 24, 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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