Bipolar Needlescopic Enucleation Versus Vapoenucleation of BPH

Bipolar Needlescopic Enucleation Versus Vapoenucleation of the Prostate: A Prospective Randomized Study

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.

Study Overview

• Status: Completed
• Conditions: Prostatic Hyperplasia; Prostatic Hypertrophy, Benign; Prostate Obstruction
• Intervention / Treatment: Procedure: Bipolar Vapo-Enucleation of the prostate; Procedure: Bipolar Needlescopic Enucleation of the prostate

Detailed Description

Aim: compare safety and efficacy and adverse events of endoscopic enucleation of large prostate using hot knife electrode (needloscopic enucleation) versus the standard vaporization electrode ( vapoenucleation) patients & methods: Patients will randomly be divided into two equal groups: Group A: Patient will be subjected to bipolar endoscopic enucleation of the prostate by vaporization electrode (vapoenucleation).

Group B: Patient will be subjected to endoscopic enucleation of the prostate by bipolar hot kife electrode (needloscopic enucleation) Inclusion criteria: patients with Qmax of less than 15 mL/second due to BPH, severe LUTS/BPH requiring surgical treatment, and International Prostate Symptom Score (IPSS)>7 due to BPH.

exclusion criteria: prostate and/or bladder cancer, bladder diverticula, urethral stricture, active urinary tract infection (UTI), unless treated, and men with neurogenic voiding dysfunction.

Operative Technique: Endoscopic enucleation of the prostate in saline utilizing either bipolar vaporization electrode or bipolar hot knife (collin's) electrode.

follow up: operative time, resected tissue weight, cath time, hospital stay and change of; IPSS,QOL, Qmax, PVR, PSA, IIEF-5 & MSHQ-EjD besides; perioperative adverse events are recorded & followed-up.

• Study Type: Interventional
• Enrollment (Actual): 214
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Kalubyia
    • Banhā, Kalubyia, Egypt, 13511
      • Banha University Hospitals

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 48 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

Inclusion Criteria:

• patients with Qmax of less than 15 mL/second due to BPH, severe LUTS/BPH requiring surgical treatment, and International Prostate Symptom Score (IPSS)>7 due to BPH.

Exclusion Criteria:

• prostate and/or bladder cancer, bladder diverticula, urethral stricture, active urinary tract infection (UTI), unless treated, and men with neurogenic voiding dysfunction.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: vapoenucleation group; Group A	Procedure: Bipolar Vapo-Enucleation of the prostate; group A: Patient will be subjected to bipolar endoscopic enucleation of the prostate by vaporization electrode (vapoenucleation).; Other Names: BVEP
Active Comparator: needlescopic enucleation; group B	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 ).; Other Names: BNEP

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
IPSS	international prostate symptoms score (range 0 -35, the lower value is better)	change of IPSS from Basline at 1,3 and 6 months postoperatively

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
QOL	Quality of life questionnaire (range 0 - 6, the lower value is better)	Change of QOL from Basline at 1,3 and 6 months postoperatively
Qmax	maximum urinary flow rate (it ranges from 0(retention) to 25 mL/s or more the higher value is better)	Change of Qmax from Basline at 1,3 and 6 months postoperatively
PVRU	Post-operative residual urine (volume it ranges from 0 ml (normal) to more than 1 liter the lower value is better	Change of PVRU from Basline at 1,3 and 6 months postoperatively
TRUS measured prostate volume	Prostate volume measured by Transrectal Ultrasonography the lower value is better	Change of PV from Basline at 1,3 and 6 months postoperatively

Collaborators and Investigators

• Sponsor: Benha University
• Investigators: Principal Investigator: Waleed El-Shaer, waleed_elshaer@hotmail.com

Study record dates

Study Major Dates

• Study Start (Actual): January 10, 2017
• Primary Completion (Actual): March 1, 2022
• Study Completion (Actual): March 10, 2022

Study Registration Dates

• First Submitted: March 29, 2020
• First Submitted That Met QC Criteria: March 31, 2020
• First Posted (Actual): April 2, 2020

Study Record Updates

• Last Update Posted (Actual): May 2, 2022
• Last Update Submitted That Met QC Criteria: April 26, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Keywords: BPH, IPSS, Bipolar
• Additional Relevant MeSH Terms: Pathologic Processes; Prostatic Diseases; Pathological Conditions, Anatomical; Prostatic Hyperplasia; Hyperplasia; Hypertrophy
• Other Study ID Numbers: IDIRB2017122601-09

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No