Back to resultsComparison of Holmium Laser Enucleation Prostatectomy and Open Transvesical Prostatectomy in Large Prostate
Primary Purpose
Benign Prostatic Hyperplasia
Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Holep
Sponsored by
About this trial
This is an interventional treatment trial for Benign Prostatic Hyperplasia
Eligibility Criteria
Inclusion Criteria:
- American Urological Association Symptom Score of eight or higher,
- Maximum urinary flow rate of 10ml/s or less,
- Post void residual urine volume of 50 ml or more,
- And a total prostate volume of 80 ml or more in transrectal ultrasound (TRUS).
Exclusion Criteria:
- A previous prostate or urethral surgery
- And non-BPH related voiding disorders
- Prostate cancer patients
Sites / Locations
- Mohamed Alnoomani
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Holep
open prostatectomy
Arm Description
patient underwent laser prostatectomy
patient underwent open prostatectomy
Outcomes
Primary Outcome Measures
efficacy by measuring maximum urinary flow rate in millilitre per second
change of maximum urinary flow rate in mililiter per second pre and post opeartive
efficacy in american urological association symptom score
change of american urological association symptom score pre and post operative by scale from 1 to 35
efficacy of evacuation by measuring post-voiding residual urine volume in millilitre
change of post-voiding residual urine volume in millilitre
Secondary Outcome Measures
safety by doing blood picture to asses hemoglobin drop
rate of hemoglobin drop post-operatively by gram per decilitre
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04471155
Brief Title
Comparison of Holmium Laser Enucleation Prostatectomy and Open Transvesical Prostatectomy in Large Prostate
Official Title
Comparison of Holmium Laser Enucleation Prostatectomy and Open Transvesical Prostatectomy in Large Prostate More Than 80 Grams in Egyptian Men
Study Type
Interventional
2. Study Status
Record Verification Date
July 2020
Overall Recruitment Status
Completed
Study Start Date
April 1, 2018 (Actual)
Primary Completion Date
April 1, 2020 (Actual)
Study Completion Date
April 22, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ain Shams University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
comparison of holmium laser enucleation prostatectomy and open prostatectomy regarding safety and efficacy in men with prostate larger than 80 grams
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Benign Prostatic Hyperplasia
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
randomized controlled trial
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
110 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Holep
Arm Type
Active Comparator
Arm Description
patient underwent laser prostatectomy
Arm Title
open prostatectomy
Arm Type
Active Comparator
Arm Description
patient underwent open prostatectomy
Intervention Type
Procedure
Intervention Name(s)
Holep
Other Intervention Name(s)
open prostatectomy
Intervention Description
laser enucleation of the gland versus open enucleation
Primary Outcome Measure Information:
Title
efficacy by measuring maximum urinary flow rate in millilitre per second
Description
change of maximum urinary flow rate in mililiter per second pre and post opeartive
Time Frame
1 year
Title
efficacy in american urological association symptom score
Description
change of american urological association symptom score pre and post operative by scale from 1 to 35
Time Frame
1 year
Title
efficacy of evacuation by measuring post-voiding residual urine volume in millilitre
Description
change of post-voiding residual urine volume in millilitre
Time Frame
1 year
Secondary Outcome Measure Information:
Title
safety by doing blood picture to asses hemoglobin drop
Description
rate of hemoglobin drop post-operatively by gram per decilitre
Time Frame
immediate post-operative
10. Eligibility
Sex
Male
Gender Based
Yes
Gender Eligibility Description
only males have prostate
Minimum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
American Urological Association Symptom Score of eight or higher,
Maximum urinary flow rate of 10ml/s or less,
Post void residual urine volume of 50 ml or more,
And a total prostate volume of 80 ml or more in transrectal ultrasound (TRUS).
Exclusion Criteria:
A previous prostate or urethral surgery
And non-BPH related voiding disorders
Prostate cancer patients
Facility Information:
Facility Name
Mohamed Alnoomani
City
Cairo
State/Province
القاهرة
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Comparison of Holmium Laser Enucleation Prostatectomy and Open Transvesical Prostatectomy in Large Prostate
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