Ignite Creation Date:
2024-05-06 @ 2:29 PM
Last Modification Date:
2024-10-26 @ 1:31 PM
Study NCT ID:
NCT04331301
Status:
COMPLETED
Last Update Posted:
2022-05-02
First Post:
2020-03-29
Brief Title:
Bipolar Needlescopic Enucleation Versus Vapoenucleation of BPH
Sponsor:
Benha University
Organization:
Benha University
Study Overview
Official Title:
Bipolar Needlescopic Enucleation Versus Vapoenucleation of the Prostate A Prospective Randomized Study
Status:
COMPLETED
Status Verified Date:
2022-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 167 of the patients suffering from early irritative symptoms while Geavlete reported that 114 of patient suffering from early irritative symptoms
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 167 of the patients suffering from early irritative symptoms while Geavlete reported that 114 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 mLsecond due to BPH severe LUTSBPH requiring surgical treatment and International Prostate Symptom Score IPSS7 due to BPH
exclusion criteria prostate andor 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 collins electrode
follow up operative time resected tissue weight cath time hospital stay and change of IPSSQOL Qmax PVR PSA IIEF-5 MSHQ-EjD besides perioperative adverse events are recorded followed-up
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 mLsecond due to BPH severe LUTSBPH requiring surgical treatment and International Prostate Symptom Score IPSS7 due to BPH
exclusion criteria prostate andor 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 collins electrode
follow up operative time resected tissue weight cath time hospital stay and change of IPSSQOL Qmax PVR PSA IIEF-5 MSHQ-EjD besides perioperative adverse events are recorded followed-up
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None