Prostate Bipolar Enucleation and Resection Versus Open Prostatectomy

Helwan University

Status: Completed

Conditions: Benign Prostatic Hyperplasia

Treatments: Procedure: open surgical transvesical prostatectomy; Procedure: transurethral bipolar enucleation and resection of the prostate

Study type: Interventional

Funder types: Other

Identifiers

NCT05416606

51-2020

Details and patient eligibility

About

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.

Full 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).

Enrollment: 64 patients

Sex: Male

Ages: 50+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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64 participants in 2 patient groups

transurethral bipolar enucleation and resection of the prostate

Active Comparator group

Description:

transurethral bipolar enucleation and resection of the prostate

Treatment:

Procedure: transurethral bipolar enucleation and resection of the prostate

open prostatectomy

Active Comparator group

Description:

open surgical transvesical prostatectomy

Treatment:

Procedure: open surgical transvesical prostatectomy