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Bipolar Needlescopic Enucleation Versus Vapoenucleation of BPH

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04331301
Enrollment
214
Registered
2020-04-02
Start date
2017-01-10
Completion date
2022-03-10
Last updated
2022-05-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prostate Obstruction, Prostatic Hyperplasia, Prostatic Hypertrophy, Benign

Keywords

BPH, IPSS, Bipolar

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.

Interventions

PROCEDUREBipolar Vapo-Enucleation of the prostate

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

PROCEDUREBipolar 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

Benha University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Masking description

interventions are blinded to both patients and doctors who 1ry assess and follow-up patients.

Eligibility

Sex/Gender
MALE
Age
50 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
IPSSchange of IPSS from Basline at 1,3 and 6 months postoperativelyinternational prostate symptoms score (range 0 -35, the lower value is better)

Secondary

MeasureTime frameDescription
TRUS measured prostate volumeChange of PV from Basline at 1,3 and 6 months postoperativelyProstate volume measured by Transrectal Ultrasonography the lower value is better
QOLChange of QOL from Basline at 1,3 and 6 months postoperativelyQuality of life questionnaire (range 0 - 6, the lower value is better)
QmaxChange of Qmax from Basline at 1,3 and 6 months postoperativelymaximum urinary flow rate (it ranges from 0(retention) to 25 mL/s or more the higher value is better)
PVRUChange of PVRU from Basline at 1,3 and 6 months postoperativelyPost-operative residual urine (volume it ranges from 0 ml (normal) to more than 1 liter the lower value is better

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026