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NCT Number: NCT04275076

HoLEP Vs BPEP for Large Prostatic Adenoma

Benign prostatic hyperplasia (BPH) is one of the most common urinary disorders in elderly males. The symptoms of BPH include impaired physiological and functional well-being, which interferes with daily living.

At present, transurethral resection of the prostate (TURP) is the standard surgical treatment. However, the high rate of complications associated with TURP is a major drawback of this procedure.

Holmium laser enucleation of the prostate (HoLEP) was proven to be an effective surgical treatment for BPH with no prostate size limitation with adequate hemostasis, bipolar enucleation of the prostate (BPEP) has been introduced as an alternative energy source with a promising outcome with equal safety and efficacy

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Key information

Sex eligibility

Male

Study type

Interventional

Phase

Phase 3

Primary location

Ain Shams University Hospitals

Cairo, 11361, Egypt

About this study

Enlarged prostate represents the most common cause of lower urinary tract symptoms (LUTS) in elderly men including irritative, obstructive urinary symptoms or even urinary retention that significantly affects the quality life (QoL).

Transurethral resection of the prostate (TURP) represents the standard surgical technique for the management of benign prostatic hyperplasia (BPH) with a prostate size less than 80 ml. However, considerable morbidities are associated with larger sizes.

Endoscopic enucleation of the prostate (EEP) has been recognized as a treatment option for large prostatic adenomas, since first described by Hiraoka et.al, in 1986, it started to gain popularity despite the long learning curve. Many studies have evaluated its efficacy against the gold standard open prostatectomy in large prostate size more than 80ml and showed its safety and efficacy.

EEP represents an anatomical surgical technique resembling a surgeon's finger in open prostatectomy where any energy source that provides adequate haemostasis could be used. Many studies concluded that EEP relies on the surgeon's skills rather than the energy source itself. Holmium laser enucleation of the prostate (HoLEP) was first described by Gilling in 1998 and was proven to be effective with no prostate size limitation with adequate haemostasis, recently it has been approved as a standard treatment for large prostatic adenoma, bipolar enucleation of the prostate (BPEP) has been introduced as an alternative energy source with a promising outcome with equal safety and efficacy.

Few studies evaluated both techniques, one study was done by Shoma et al. showing no statistical difference regarding safety and efficacy between both techniques, another study conducted by Enikeev et al. reported earlier recovery and catheter removal with HoLEP compared to BPEP. However, cost-effectiveness was never been evaluated before between both techniques especially in developing countries.

With such scarce information, the investigators aimed through this study to compare these two energy sources in the enucleation procedure of the prostate in terms of safety, efficacy, and cost-effectiveness in the management of BPH in large prostatic adenoma more than 80 ml.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Men who are fit for surgery and need a surgical resection of the prostate larger than 80 ml including:
  • Bothersome LUTS with an IPSS score over 19
  • Refractory hematuria
  • Upper urinary tract affection
  • Recurrent UTI secondary to prostatic enlargement
  • Maximum uroflow rate (Qmax) below 10 ml/sec.
  • bladder diverticula
  • Urinary retention whether recurrent acute attacks with failure of medical treatment or chronic retention.

Exclusion criteria

  • Patients with:
  • Neurogenic bladder
  • Previous prostate or urethral surgery
  • Associated urethral stricture
  • Prostate cancer diagnosed by TRUS biopsy
  • Bladder stones,

Treatment and study plan

Holmium laser enucleation of the prostate versus bipolar transurethral enucleation of the prostate in management of benign prostatic hyperplasia

Procedure

comparison between 2 energy sources of enucleation in management of benign prostatic hyperplasia, holmium laser versus bipolar energy source in trans-urethral enucleation of the prostate

Primary outcomes

  1. operative time

    Time frame: 50-120 minutes

    form the beginning of endoscopic procedure till catheter insertion

Secondary outcomes

  1. Enucleation efficacy of HoLEP

    Time frame: 12 months

    Mean Enucleation time (HoLEP) in minutes divided by Mean resected volume in grams

  2. Enucleation efficacy of BEEP

    Time frame: 12 months

    Mean Enucleation time (BPEP) in minutes/ Mean resected volume in grams

  3. Mean energy in (HoLEP) in joules

    Time frame: intra-operative finding

    Mean energy in (HoLEP) in joules

  4. irrigation fluid

    Time frame: intra-operative finding

    Average Irrigation fluid used in each group in liters

  5. catheter removal time

    Time frame: 1-7 days

    postoperative time till catheter removal

  6. resected volume

    Time frame: intra-operative finding

    resected volume in grams

  7. hemoglobin drop

    Time frame: intra-operative finding

    blood loss in dl/ml

  8. conversion to other type of surgery

    Time frame: intra-operative finding

    conversion to other types of surgeries like TURP, open surgery, procedure abortion

  9. Operative safety:

    Time frame: intra-operative finding

    capsular perforation, Yes/No

  10. Operative safety:

    Time frame: intra-operative finding

    morcellation injury, Yes/No

  11. early post operative complication

    Time frame: 1 month

    stress incontinence, Yes/No

  12. early post operative complication

    Time frame: 1 month

    urinary tract infection, Yes/No

  13. early post operative complication

    Time frame: 1 month

    urine retention, Yes/No

  14. Postoperative efficacy:

    Time frame: 12 months

    IPSS: international prostate symptom score

  15. Postoperative efficacy:

    Time frame: 12 months

    QoL: quality of life questionnaire

  16. Postoperative efficacy:

    Time frame: 12 months

    Qmax (m/sec.) : peak flow rate

  17. Postoperative efficacy:

    Time frame: 12 months

    PVRU (ml): post voiding residual urine

  18. Postoperative efficacy:

    Time frame: 12 months

    PSA (ng/ml): prostatic specific antigen

  19. Postoperative efficacy:

    Time frame: 12 months

    postoperative prostate volume assessment in grams

  20. cost effectiveness

    Time frame: 12 months

    Running cost in Egyptian pounds of the following: irrigation fluid, hospital stay, fiber, loop, management of complication in each group

  21. hospital stay

    Time frame: 1-7 days

    duration of postoperative hospital stay in days

  22. Cost analysis

    Time frame: 1 year

    average running cost evaluation in both procedure

Sponsors and collaborators

Lead sponsor

Ahmed Maher Gamil Ahmed Higazy

Other

Registry information

Official study title

Holmium Laser Enucleation of the Prostate Versus Bipolar Transurethral Enucleation of the Prostate in Management of Benign Prostatic Hyperplasia A Randomized Controlled Trial

Acronym: enucleation

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Feb 19, 2020
Registry last updated
Jun 16, 2020

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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