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Completed

NCT Number: NCT05416606

Prostate Bipolar Enucleation and Resection Versus Open Prostatectomy

Benign prostatic hyperplasia (BPH) is a frequent disease in aging men accompanied by bladder outlet obstruction (BOO). Open prostatectomy (OP) is still considered the first-line treatment for more than 80 ml prostate size. In this study, a mixed technique called transurethral bipolar enucleation and resection of the prostate (TBERP) was compared to the standard open prostatectomy.

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Key information

Conditions

Benign Prostatic Hyperplasia Genital Diseases Genital Diseases, Male Male Urogenital Diseases Prostatic Diseases Prostatic Hyperplasia Urogenital Diseases

Age range

50 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Helwan university faculty of medicine

Helwan, 11731, Egypt

About this study

Benign prostatic hyperplasia (BPH) is a frequent disease in aging men accompanied by bladder outlet obstruction (BOO). Open prostatectomy (OP) is still considered the first-line treatment for more than 80 ml prostate size. In this study, a mixed technique called transurethral bipolar enucleation and resection of the prostate (TBERP) was compared to the standard open prostatectomy.

This is a Comparative, Prospective Study conducted on men over 50 years.The patients were randomly distributed into two groups treated by TBERP and OP. Patients were evaluated preoperatively and at 1-week post catheter removal and 1-3-months postoperatively in terms of blood loss, operation time, the weight of resected prostatic tissues, post-operative catheterisation period, hospital stay, IPSS, PVR, prostate volume, early complications (recatheterization, urine retention, UTI and irritative symptoms) and late complications (urinary incontinence, urethral stricture and bladder neck contracture).

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Male patients
  • Age more than 50 years
  • Prostate size of more than 80 ml
  • IPSS ≥ 8, and maximum urinary flow rate (Qmax) ≤ 15 mL/s
  • Indications for surgery
  • Refractory retention (failed ≥1 trial of voiding).
  • Associated bladder Stones.
  • Associated recurrent gross Hematuria.
  • Associated with recurrent Infections.
  • Associated renal insufficiency.
  • Bother symptoms refractory to medical treatment.

Exclusion criteria

  • Uncorrectable coagulopathy.
  • Patient with active UTI.
  • Prostate less than 80 ml.
  • Severe associated comorbidities.
  • Previous urethral, prostate, and bladder surgeries,
  • Patients diagnosed with neurogenic bladder.
  • Patients diagnosed with prostate cancer.

Treatment and study plan

transurethral bipolar enucleation and resection of the prostate

Procedure

transurethral bipolar enucleation and resection of the prostate

Other names: TUVERP

open surgical transvesical prostatectomy

Procedure

open surgical transvesical prostatectomy

Other names: Transvesical prostatectomy

Primary outcomes

  1. operative time

    Time frame: Three months

    To measure the difference between the two procedure regarding operative time measured in minutes.

  2. recovery outcome

    Time frame: Three months

    To measure the difference between the two procedure regarding mean hospital stays measured in days and catheterization period measured in days

Secondary outcomes

  1. peri-operative complication

    Time frame: Three months

    to measure the difference between the two procedures regarding incidence of early complications including re-catheterization, acute urinary retention, early irritative symptoms and urinary tract infections and incidence of late complications Including urinary incontinence, Urethral strictures,and bladder neck contracture.

  2. weight of resected prostatic tissues

    Time frame: Three months

    to measure the difference between the two procedures regarding weight of resected prostatic tissues Measured in gram

  3. post-operative International Prostate Symptom Score (IPSS) score.

    Time frame: Three months

    to measure the difference between the two procedures regarding IPSS score. Score 0 to 7 points considered mild symptoms, 8 to 19 points considered moderate symptoms, 20 to 35 points considered severe symptoms

Sponsors and collaborators

Lead sponsor

Helwan University

Other

Registry information

Official study title

Transurethral Bipolar Enucleation and Resection of the Prostate Versus Open Prostatectomy for the Treatment of Benign Prostatic Hyperplasia

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Jun 13, 2022
Registry last updated
Jun 13, 2022

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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