Back to resultsEjaculation Preserving Photoselective Vaporization Versus Plasma Kinetic Vaporization Versus Transurethral Resection Of The Prostate: A RCT (EPPROSTATECT)
Primary Purpose
Ejaculation Abnormal, BPH With Urinary Obstruction, Prostatic Hyperplasia
Status
Unknown status
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Ejaculation Preserving Photoselective Vaporization
Ejaculation Preserving Plasma Kinetic Vaporization
Ejaculation Preserving Transurethral Resection Of The Prostate
Sponsored by
About this trial
This is an interventional treatment trial for Ejaculation Abnormal
Eligibility Criteria
Inclusion Criteria:
1. Age >50 years 2. Prostate volume (measured by TRUS): 30-80 gm 3. International prostate symptom score (IPSS )>15 and quality of life score (QOL)< 3.
4. Maximum flow rate of uroflometry <10 ml/second 5. Patients with active sexual life (or interested) and having the ability to ejaculate and desire to preserve ejaculation.
6. Failure or intolerance to medical treatment, recurrent urinary infection, urine retention, significant hematuria or deterioration of the upper urinary tract function secondary to BOO.
Exclusion Criteria:
- Bleeding disorders and patients on anticoagulant treatment
- Histologically proved cancer prostate
- Neurogenic voiding dysfunction
- Lower urinary tract malignancy
- Preoperative ejaculation or sexual dysfunction
- Presence of stricture urethra
- Unfit for spinal anathesia -
Sites / Locations
- Urology & Nephrology Center
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Active Comparator
Arm Label
Photoselective Vaporization
Plasma Kinetic Vaporization
Transurethral Resection Of The Prostate
Arm Description
Outcomes
Primary Outcome Measures
estimate and compare the ejaculation preservation effect of the 3 techniques (PKVP, PVP and TURP).
assessed by Male Sexual Health Questionnaire (MSHQ)
Secondary Outcome Measures
change in flow rate
measured by uroflowmetery in ml/sec
postoperative complication
measured by Clavien-Dindo Classification scale
change in patients' symptoms.
measured by International Prostate Symptom Score (I-PSS)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03589196
Brief Title
Ejaculation Preserving Photoselective Vaporization Versus Plasma Kinetic Vaporization Versus Transurethral Resection Of The Prostate: A RCT
Acronym
EPPROSTATECT
Official Title
Ejaculation Preserving Photoselective Vaporization Versus Plasma Kinetic Vaporization Versus Transurethral Resection Of The Prostate For Management Of Benign Prostatic Enlargement: An Objective Evaluation Through a Prospective Randomized Trial
Study Type
Interventional
2. Study Status
Record Verification Date
March 2018
Overall Recruitment Status
Unknown status
Study Start Date
March 10, 2018 (Actual)
Primary Completion Date
June 1, 2019 (Anticipated)
Study Completion Date
December 1, 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Mansoura University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
To Evaluate and compare the outcome and coast of ejaculation sparing management of BPH using 3 different techniques: PVP, PKVP and TURP. Ejaculation sparing TURP group is considered the standard control group. Evaluation will be carried out through a prospective randomized powered trial
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ejaculation Abnormal, BPH With Urinary Obstruction, Prostatic Hyperplasia, Prostate Disease, Prostate Obstruction
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
84 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Photoselective Vaporization
Arm Type
Active Comparator
Arm Title
Plasma Kinetic Vaporization
Arm Type
Active Comparator
Arm Title
Transurethral Resection Of The Prostate
Arm Type
Active Comparator
Intervention Type
Procedure
Intervention Name(s)
Ejaculation Preserving Photoselective Vaporization
Intervention Description
Ejaculation Preserving Photoselective Vaporization
Intervention Type
Procedure
Intervention Name(s)
Ejaculation Preserving Plasma Kinetic Vaporization
Intervention Description
Ejaculation Preserving Plasma Kinetic Vaporization
Intervention Type
Procedure
Intervention Name(s)
Ejaculation Preserving Transurethral Resection Of The Prostate
Intervention Description
Ejaculation Preserving Transurethral Resection Of The Prostate
Primary Outcome Measure Information:
Title
estimate and compare the ejaculation preservation effect of the 3 techniques (PKVP, PVP and TURP).
Description
assessed by Male Sexual Health Questionnaire (MSHQ)
Time Frame
1 years
Secondary Outcome Measure Information:
Title
change in flow rate
Description
measured by uroflowmetery in ml/sec
Time Frame
1 years
Title
postoperative complication
Description
measured by Clavien-Dindo Classification scale
Time Frame
1 year
Title
change in patients' symptoms.
Description
measured by International Prostate Symptom Score (I-PSS)
Time Frame
1 year
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
1. Age >50 years 2. Prostate volume (measured by TRUS): 30-80 gm 3. International prostate symptom score (IPSS )>15 and quality of life score (QOL)< 3.
4. Maximum flow rate of uroflometry <10 ml/second 5. Patients with active sexual life (or interested) and having the ability to ejaculate and desire to preserve ejaculation.
6. Failure or intolerance to medical treatment, recurrent urinary infection, urine retention, significant hematuria or deterioration of the upper urinary tract function secondary to BOO.
Exclusion Criteria:
Bleeding disorders and patients on anticoagulant treatment
Histologically proved cancer prostate
Neurogenic voiding dysfunction
Lower urinary tract malignancy
Preoperative ejaculation or sexual dysfunction
Presence of stricture urethra
Unfit for spinal anathesia -
Facility Information:
Facility Name
Urology & Nephrology Center
City
Mansourah
Country
Egypt
12. IPD Sharing Statement
Learn more about this trial
Ejaculation Preserving Photoselective Vaporization Versus Plasma Kinetic Vaporization Versus Transurethral Resection Of The Prostate: A RCT
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