MedTrace Logo

Bipolar Needlescopic Enucleation Versus Vapoenucleation of BPH

NCT04331301 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 214

Last updated 2022-05-02

No results posted yet for this study

Summary

Transurethral resection of the prostate (TURP) is the current standard procedure for men with prostate volume 30-80 gm. In case with large prostate adenoma (\>80 g), the resection time required by TURP is associated with increased risk of TUR syndrome, blood loss and other complications.

Many types of minimally invasive surgery exist along with new equipment and techniques. Many types of laser devices such as greenlight laser, thulium laser and holmium laser, are used to enucleate the prostate. Increasing evidence has proven their safety and efficacy However, the use of laser devices is difficult and associated with steep learning curve and high medical expenses.

PKEP is a safe and effective procedure for the treatment of bladder obstruction secondary to BPH. This procedure not only improves maximum flow rate at 3 and 12 months after surgery, but it also improves all other recorded parameters (IPSS, QOL, IEFF-5, PVR, PSA).

A button electrode can be effectively used to enucleate the prostate because of its powerful vaporisation and strong coagulation (B-TUEP technique) ,such as that with a holmium laser, thulium laser and greenlight laser. However its associated with short term complication as early irritative symptoms, Bulai reported that 16.7% of the patients suffering from early irritative symptoms while Geavlete reported that 11.4% of patient suffering from early irritative symptoms.

Conditions

  • Prostate Obstruction
  • Prostatic Hyperplasia
  • Prostatic Hypertrophy, Benign

Interventions

PROCEDURE

Bipolar Vapo-Enucleation of the prostate

group A: Patient will be subjected to bipolar endoscopic enucleation of the prostate by vaporization electrode (vapoenucleation).

PROCEDURE

Bipolar Needlescopic Enucleation of the prostate

group B: Patient will be subjected to bipolar endoscopic enucleation of the prostate by hot knife electrode (Needlescopic Enucleation ).

Sponsors & Collaborators

  • Benha University

    lead OTHER

Principal Investigators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
50 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-01-10
Primary Completion
2022-03-01
Completion
2022-03-10

Countries

  • Egypt

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04331301 on ClinicalTrials.gov