Skip to main content
OpenTrials
Completed

NCT Number: NCT04331301

Bipolar Needlescopic Enucleation Versus Vapoenucleation of BPH

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Prostate Obstruction Genital Diseases Genital Diseases, Male Male Urogenital Diseases Prostatic Diseases Prostatic Hyperplasia Prostatic Hypertrophy, Benign Urogenital Diseases

Age range

50 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Banha University Hospitals

Banhā, Kalubyia, 13511, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Bipolar Vapo-Enucleation of the prostate

Procedure

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

Other names: BVEP

Bipolar Needlescopic Enucleation of the prostate

Procedure

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

Other names: BNEP

Primary outcomes

  1. IPSS

    Time frame: change of IPSS from Basline at 1,3 and 6 months postoperatively

    international prostate symptoms score (range 0 -35, the lower value is better)

Secondary outcomes

  1. QOL

    Time frame: Change of QOL from Basline at 1,3 and 6 months postoperatively

    Quality of life questionnaire (range 0 - 6, the lower value is better)

  2. Qmax

    Time frame: Change of Qmax from Basline at 1,3 and 6 months postoperatively

    maximum urinary flow rate (it ranges from 0(retention) to 25 mL/s or more the higher value is better)

  3. PVRU

    Time frame: Change of PVRU from Basline at 1,3 and 6 months postoperatively

    Post-operative residual urine (volume it ranges from 0 ml (normal) to more than 1 liter the lower value is better

  4. TRUS measured prostate volume

    Time frame: Change of PV from Basline at 1,3 and 6 months postoperatively

    Prostate volume measured by Transrectal Ultrasonography the lower value is better

Sponsors and collaborators

Lead sponsor

Benha University

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2022
Study completion
2022
First posted
Apr 2, 2020
Registry last updated
May 2, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.