Clinical trial NCT05416606: Prostate Bipolar Enucleation and Resection Versus Open Prostatectomy
Official title: Transurethral Bipolar Enucleation and Resection of the Prostate Versus Open Prostatectomy for the Treatment of Benign Prostatic Hyperplasia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Benign Prostatic Hyperplasia
Keywords: Transurethral enucleation
Transurethral enucleation and resection of the prostate
plasma enucleation
prostate enucleation
Open Prostatectomy
BPH
Benign prostatic hyperplasia
Lead sponsor: Helwan University
Sponsor class: OTHER
First posted: 2022-06-13
Enrollment: 64
Sex: MALE
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: In this study, a hybrid technique, that combines two types of techniques using the same cutting current and technological setup, will be proposed enucleation of the prostate gland with the plasma vaporization electrode and resection with a TURis cutting loop. This technique is defined as transurethral vapor enucleation and resection of the prostate (TVERP) comparing it with open prostatectomy.
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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).

Eligibility criteria: 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.

Primary outcomes:
measure: operative time
timeFrame: Three months
measure: recovery outcome
timeFrame: Three months
Secondary outcomes:
measure: peri-operative complication
timeFrame: Three months
measure: weight of resected prostatic tissues
timeFrame: Three months
measure: post-operative International Prostate Symptom Score (IPSS) score.
timeFrame: Three months
Other outcomes:
Locations:
city: Helwan
country: Egypt
facility: Helwan university faculty of medicine
Study officials:
affiliation: Helwan university faculty of medicine
name: Tarek Salem, professor
role: STUDY_DIRECTOR
References:
citation: Mahon JT, McVary KT. New Alternative Treatments for Lower Urinary Tract Symptoms Secondary to Benign Prostatic Hyperplasia. Minimally Invasive Urology: Springer; 2020. p. 283-305.
citation: Barry MJ, Fowler FJ Jr, O'leary MP, Bruskewitz RC, Holtgrewe HL, Mebust WK, Cockett AT; Measurement Committee of the American Urological Association. The American Urological Association Symptom Index for Benign Prostatic Hyperplasia. J Urol. 2017 Feb;197(2S):S189-S197. doi: 10.1016/j.juro.2016.10.071. Epub 2016 Dec 22.
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