Bipolar Needlescopic Enucleation Versus Vapoenucleation of BPH

Prostatic Hyperplasia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04331301
• Other study ID #: IDIRB2017122601-09
• Status: Completed
• Phase: N/A
• Start date: January 10, 2017
• Est. completion date: March 10, 2022

Study information

• Verified date: April 2022
• Source: Benha University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 214
• Est. completion date: March 10, 2022
• Est. primary completion date: March 1, 2022
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 50 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Hyperplasia
• Hypertrophy
• Prostate Obstruction
• Prostatic Hyperplasia
• Prostatic Hypertrophy, Benign

Intervention

Procedure:
• Bipolar Vapo-Enucleation of the prostate
group A: Patient will be subjected to bipolar endoscopic enucleation of the prostate by vaporization electrode (vapoenucleation).
• 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 ).

Locations

Country	Name	City	State
Egypt	Banha University Hospitals	Banha	Kalubyia

Sponsors (1)

Lead Sponsor	Collaborator
Benha University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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