Clinical trial NCT04331301: Bipolar Needlescopic Enucleation Versus Vapoenucleation of BPH
Official title: Bipolar Needlescopic Enucleation Versus Vapoenucleation of the Prostate: A Prospective Randomized Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Prostate Obstruction
Prostatic Hyperplasia
Prostatic Hypertrophy, Benign
Keywords: BPH, IPSS, Bipolar
Lead sponsor: Benha University
Sponsor class: OTHER
First posted: 2020-04-02
Enrollment: 214
Sex: MALE
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: IPSS
timeFrame: change of IPSS from Basline at 1,3 and 6 months postoperatively
Secondary outcomes:
measure: QOL
timeFrame: Change of QOL from Basline at 1,3 and 6 months postoperatively
measure: Qmax
timeFrame: Change of Qmax from Basline at 1,3 and 6 months postoperatively
measure: PVRU
timeFrame: Change of PVRU from Basline at 1,3 and 6 months postoperatively
measure: TRUS measured prostate volume
timeFrame: Change of PV from Basline at 1,3 and 6 months postoperatively
Other outcomes:
Locations:
city: Banhā
country: Egypt
facility: Banha University Hospitals
state: Kalubyia
Study officials:
affiliation: waleed_elshaer@hotmail.com
name: Waleed El-Shaer
role: PRINCIPAL_INVESTIGATOR
References: