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Bipolar Needlescopic Enucleation Versus Vapoenucleation of BPH

Primary Purpose

Prostate Obstruction, Prostatic Hyperplasia, Prostatic Hypertrophy, Benign

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Bipolar Vapo-Enucleation of the prostate
Bipolar Needlescopic Enucleation of the prostate
Sponsored by
Benha University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Prostate Obstruction focused on measuring BPH, IPSS, Bipolar

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Banha University Hospitals

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

vapoenucleation group

needlescopic enucleation

Arm Description

Group A

group B

Outcomes

Primary Outcome Measures

IPSS
international prostate symptoms score (range 0 -35, the lower value is better)

Secondary Outcome Measures

QOL
Quality of life questionnaire (range 0 - 6, the lower value is better)
Qmax
maximum urinary flow rate (it ranges from 0(retention) to 25 mL/s or more the higher value is better)
PVRU
Post-operative residual urine (volume it ranges from 0 ml (normal) to more than 1 liter the lower value is better
TRUS measured prostate volume
Prostate volume measured by Transrectal Ultrasonography the lower value is better

Full Information

First Posted
March 29, 2020
Last Updated
April 26, 2022
Sponsor
Benha University
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1. Study Identification

Unique Protocol Identification Number
NCT04331301
Brief Title
Bipolar Needlescopic Enucleation Versus Vapoenucleation of BPH
Official Title
Bipolar Needlescopic Enucleation Versus Vapoenucleation of the Prostate: A Prospective Randomized Study
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Completed
Study Start Date
January 10, 2017 (Actual)
Primary Completion Date
March 1, 2022 (Actual)
Study Completion Date
March 10, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Benha University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Obstruction, Prostatic Hyperplasia, Prostatic Hypertrophy, Benign
Keywords
BPH, IPSS, Bipolar

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Masking Description
interventions are blinded to both patients and doctors who 1ry assess and follow-up patients.
Allocation
Randomized
Enrollment
214 (Actual)

8. Arms, Groups, and Interventions

Arm Title
vapoenucleation group
Arm Type
Active Comparator
Arm Description
Group A
Arm Title
needlescopic enucleation
Arm Type
Active Comparator
Arm Description
group B
Intervention Type
Procedure
Intervention Name(s)
Bipolar Vapo-Enucleation of the prostate
Other Intervention Name(s)
BVEP
Intervention Description
group A: Patient will be subjected to bipolar endoscopic enucleation of the prostate by vaporization electrode (vapoenucleation).
Intervention Type
Procedure
Intervention Name(s)
Bipolar Needlescopic Enucleation of the prostate
Other Intervention Name(s)
BNEP
Intervention Description
group B: Patient will be subjected to bipolar endoscopic enucleation of the prostate by hot knife electrode (Needlescopic Enucleation ).
Primary Outcome Measure Information:
Title
IPSS
Description
international prostate symptoms score (range 0 -35, the lower value is better)
Time Frame
change of IPSS from Basline at 1,3 and 6 months postoperatively
Secondary Outcome Measure Information:
Title
QOL
Description
Quality of life questionnaire (range 0 - 6, the lower value is better)
Time Frame
Change of QOL from Basline at 1,3 and 6 months postoperatively
Title
Qmax
Description
maximum urinary flow rate (it ranges from 0(retention) to 25 mL/s or more the higher value is better)
Time Frame
Change of Qmax from Basline at 1,3 and 6 months postoperatively
Title
PVRU
Description
Post-operative residual urine (volume it ranges from 0 ml (normal) to more than 1 liter the lower value is better
Time Frame
Change of PVRU from Basline at 1,3 and 6 months postoperatively
Title
TRUS measured prostate volume
Description
Prostate volume measured by Transrectal Ultrasonography the lower value is better
Time Frame
Change of PV from Basline at 1,3 and 6 months postoperatively

10. Eligibility

Sex
Male
Gender Based
Yes
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Waleed El-Shaer
Organizational Affiliation
waleed_elshaer@hotmail.com
Official's Role
Principal Investigator
Facility Information:
Facility Name
Banha University Hospitals
City
Banhā
State/Province
Kalubyia
ZIP/Postal Code
13511
Country
Egypt

12. IPD Sharing Statement

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Bipolar Needlescopic Enucleation Versus Vapoenucleation of BPH

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