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Completed

NCT Number: NCT04143399

HoLEP vs BPRP of a Large Volume BPH: a Randomised Controlled Trial

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

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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, 12222, Egypt

About this study

To compare safety and efficacy of bipolar resection (BPRP) versus holmium laser enucleation (HoLEP) for management of large BPH (> 75 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
  • failed medical treatment
  • International Prostate Symptom Score (IPSS) > 13
  • a peak urinary flow rate (Qmax) < 15 ml/sec
  • a prostate size ≥ 75 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 (Versa pulse 100W; Lumenis; Germany)

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: Immediate postoperatively

    difference in hemoglobin concentration postoperatively vs preoperatively

  2. operative duration in minutes

    Time frame: during surgery

    operative duration

  3. Hospital stay in days

    Time frame: immediately after surgery

    Hospital stay

Secondary outcomes

  1. complications (%)

    Time frame: Two years

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

  2. urine flow

    Time frame: Two years

    Qmax (ml/s),

  3. post-voiding residual urine

    Time frame: Two years

    postvoiding residual urine (ml)

  4. International prostate symptom score (IPSS)

    Time frame: Two 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

  5. Quality of life (QoL)

    Time frame: Two years

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

  6. Catheter duration

    Time frame: immediate postoperatively

    Catheter duration in hours

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2019
Study completion
2019
First posted
Oct 29, 2019
Registry last updated
Oct 29, 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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