Back to resultsHoLEP vs. Greenlight 532nm-laser PVEP vs. Bipolar TURP in Management of Moderate/ Large BPH
Primary Purpose
Benign Prostate Hyperplasia, Lower Urinary Tract Symptoms
Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
532nm-laser photoselective vapo-enucleation of the prostate)
Holmium laser enucleation of prostate
Bipolar TURP
Sponsored by
About this trial
This is an interventional treatment trial for Benign Prostate Hyperplasia focused on measuring LASER, PROSTATE, BIPOLAR, HYPERPLASIA, VAPORIZATION
Eligibility Criteria
Inclusion Criteria:
- Patients' age ≥50 years
- LUTS secondary to BOO due to BPH who failed medical treatment
- International prostate symptom scores 8 (IPSS) >15 and bother score 8 (QOL) ≥ 3 (according to IPSS question 8)
- Peak urinary flow rate (Qmax) <15 ml/sec with at least 125 ml voided volume or Patients with acute urine retention secondary to BPH who failed trial of voiding on medical treatment.
- ASA (American society of anaesthesiologists) score ≤3.
- TRUS prostate size (>/=80ml)
Exclusion Criteria:
- Patient with neurological disorder which might affect bladder function as cerebrovascular stroke, Parkinson disease
- Active urinary tract infection,
- Presence of active bladder cancer (within the last 2 years)
- Known prostate cancer patients will be excluded preoperatively on the basis of digital rectal examination, prostate specific antigen level, and TRUS imaging followed by prostate biopsies if necessary.
Sites / Locations
- Urology and Nephrology Center
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Active Comparator
Arm Label
Greenlight (532nm-laser) PVEP
Holmium laser enucleation of prostate
Bipolar TURP
Arm Description
532nm-laser photoselective vapo-enucleation of the prostate)
Holmium-Yag laser enucleation of the prostate
Bipolar transurethral resection of the prostate in saline
Outcomes
Primary Outcome Measures
Re treatment
need for retreatment for recurrent infravesical obstruction following primary surgery
Secondary Outcome Measures
change in symptoms score
degree of improvement in the lower urinary tract symptoms
Urine Flow rate (ml/sec)
degree of improvement in the rate of urine flow
Full Information
NCT ID
NCT02332538
First Posted
December 27, 2014
Last Updated
October 13, 2019
Sponsor
Mansoura University
1. Study Identification
Unique Protocol Identification Number
NCT02332538
Brief Title
HoLEP vs. Greenlight 532nm-laser PVEP vs. Bipolar TURP in Management of Moderate/ Large BPH
Official Title
Randomized Trial Comparing Holmium Laser Enucleation of the Prostate vs. Greenlight 532nm-laser Vapo-Enucleation of the Prostate vs. Bipolar Transurethral Resection of the Prostate in Management of Moderate/Large Benign Prostate Hyperplasia
Study Type
Interventional
2. Study Status
Record Verification Date
October 2019
Overall Recruitment Status
Completed
Study Start Date
March 2014 (Actual)
Primary Completion Date
July 2016 (Actual)
Study Completion Date
July 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mansoura University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Most guidelines are not strict for recommending single treatment approach for Moderate to large prostate.
In this study the investigators planned to test the Greenlight (532-nm) laser Photoselective Vapo-Enucleation of the Prostate (PVEP) using (XPS) 180W system compared to bipolar transurethral resection of the prostate (TURis) and Holmium Laser Enucleation of the Prostate (HOLEP) in reduction of lower urinary tract symptoms (LUTS) secondary to BPH in a prospective randomized trial.
Detailed Description
With a growing body of knowledge on the promising advancements and recent clinical data of the third generations of the Greenlight XPS, it seems to be a real contender in the world of MIS. Contenders of Greenlight laser technology includes bipolar as well as Holmium laser technology.
In this study the investigators planned to test the Greenlight (532-nm) laser Photoselective Vapo-Enucleation of the Prostate (PVEP) using (XPS) 180W system compared to bipolar transurethral resection of the prostate (TURis) and Holmium Laser Enucleation of the Prostate (HOLEP) in reduction of LUTS secondary to BPH in a prospective randomized trial.
Furthermore, all peri-operative parameters, urinary flow parameters, prostate size changes and complications associated with the procedures were compared. The prostate size limitations will be assessed in relation to the outcome measures.
Moderate to large size prostate (80-120 ml TRUS estimated volume) will be randomized to PVEP vs. Bipolar TURP vs. HoLEP.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Benign Prostate Hyperplasia, Lower Urinary Tract Symptoms
Keywords
LASER, PROSTATE, BIPOLAR, HYPERPLASIA, VAPORIZATION
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
182 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Greenlight (532nm-laser) PVEP
Arm Type
Active Comparator
Arm Description
532nm-laser photoselective vapo-enucleation of the prostate)
Arm Title
Holmium laser enucleation of prostate
Arm Type
Active Comparator
Arm Description
Holmium-Yag laser enucleation of the prostate
Arm Title
Bipolar TURP
Arm Type
Active Comparator
Arm Description
Bipolar transurethral resection of the prostate in saline
Intervention Type
Procedure
Intervention Name(s)
532nm-laser photoselective vapo-enucleation of the prostate)
Intervention Description
using Greenlight (532nm-laser) modified vaporization technique, PVEP (photoselective vapo-enucleation of the prostate)
Intervention Type
Procedure
Intervention Name(s)
Holmium laser enucleation of prostate
Intervention Description
Holmium-Yag laser enucleation of the prsotate
Intervention Type
Procedure
Intervention Name(s)
Bipolar TURP
Intervention Description
Bipolar transurethral resection of the prostate in saline
Primary Outcome Measure Information:
Title
Re treatment
Description
need for retreatment for recurrent infravesical obstruction following primary surgery
Time Frame
3 YEARs
Secondary Outcome Measure Information:
Title
change in symptoms score
Description
degree of improvement in the lower urinary tract symptoms
Time Frame
3 year
Title
Urine Flow rate (ml/sec)
Description
degree of improvement in the rate of urine flow
Time Frame
3 year
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients' age ≥50 years
LUTS secondary to BOO due to BPH who failed medical treatment
International prostate symptom scores 8 (IPSS) >15 and bother score 8 (QOL) ≥ 3 (according to IPSS question 8)
Peak urinary flow rate (Qmax) <15 ml/sec with at least 125 ml voided volume or Patients with acute urine retention secondary to BPH who failed trial of voiding on medical treatment.
ASA (American society of anaesthesiologists) score ≤3.
TRUS prostate size (>/=80ml)
Exclusion Criteria:
Patient with neurological disorder which might affect bladder function as cerebrovascular stroke, Parkinson disease
Active urinary tract infection,
Presence of active bladder cancer (within the last 2 years)
Known prostate cancer patients will be excluded preoperatively on the basis of digital rectal examination, prostate specific antigen level, and TRUS imaging followed by prostate biopsies if necessary.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ahmed M Elshal, MD
Organizational Affiliation
Mansoura University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Urology and Nephrology Center
City
Mansoura
State/Province
Aldakahlia
ZIP/Postal Code
35516
Country
Egypt
12. IPD Sharing Statement
Learn more about this trial
HoLEP vs. Greenlight 532nm-laser PVEP vs. Bipolar TURP in Management of Moderate/ Large BPH
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