Bipolar Needlescopic Enucleation Versus Vapoenucleation of BPH
NCT ID: NCT04331301
Last Updated: 2022-05-02
Study Results
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Basic Information
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COMPLETED
NA
214 participants
INTERVENTIONAL
2017-01-10
2022-03-10
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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vapoenucleation group
Group A
Bipolar Vapo-Enucleation of the prostate
group A: Patient will be subjected to bipolar endoscopic enucleation of the prostate by vaporization electrode (vapoenucleation).
needlescopic enucleation
group B
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 ).
Interventions
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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 ).
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
50 Years
MALE
No
Sponsors
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Benha University
OTHER
Responsible Party
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Waleed El-Shaer, MD
Principal Investigator
Principal Investigators
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Locations
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Banha University Hospitals
Banhā, Kalubyia, Egypt
Countries
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Other Identifiers
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IDIRB2017122601-09
Identifier Type: -
Identifier Source: org_study_id
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