Prostate Bipolar Enucleation and Resection Versus Open Prostatectomy

Not Applicable

Completed

• Conditions: Benign Prostatic Hyperplasia
• Interventions: Procedure: transurethral bipolar enucleation and resection of the prostate; Procedure: open surgical transvesical prostatectomy

• Registration Number: NCT05416606
• Lead Sponsor: Helwan University

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).

Study Timeline

• Study Start: 2020-10-01
• Status Verified: 2022-06
• Primary Completion: 2022-06-01
• Study Completion: 2022-06-01
• Study First Submitted: 2022-06-05
• Study First Submitted QC: 2022-06-08
• Last Update Submitted: 2022-06-08
• Study First Posted: 2022-06-13
• Last Update Posted: 2022-06-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 64

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
transurethral bipolar enucleation and resection of the prostate	transurethral bipolar enucleation and resection of the prostate	transurethral bipolar enucleation and resection of the prostate
open prostatectomy	open surgical transvesical prostatectomy	open surgical transvesical prostatectomy

Primary Outcome Measures

Name	Time	Method
operative time	Three months	To measure the difference between the two procedure regarding operative time measured in minutes.
recovery outcome	Three months	To measure the difference between the two procedure regarding mean hospital stays measured in days and catheterization period measured in days

Secondary Outcome Measures

Name	Time	Method
peri-operative complication	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.
post-operative International Prostate Symptom Score (IPSS) score.	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
weight of resected prostatic tissues	Three months	to measure the difference between the two procedures regarding weight of resected prostatic tissues Measured in gram

Trial Locations

Locations (1)

Helwan university faculty of medicine; 🇪🇬 Helwan, Egypt