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Ejaculation Preserving Photoselective Vaporization Versus Plasma Kinetic Vaporization Versus Transurethral Resection Of The Prostate: A RCT (EPPROSTATECT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03589196
Recruitment Status : Enrolling by invitation
First Posted : July 17, 2018
Last Update Posted : July 17, 2018
Sponsor:
Information provided by (Responsible Party):
Mansoura University

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

Condition or disease Intervention/treatment Phase
Ejaculation Abnormal BPH With Urinary Obstruction Prostatic Hyperplasia Prostate Disease Prostate Obstruction Procedure: Ejaculation Preserving Photoselective Vaporization Procedure: Ejaculation Preserving Plasma Kinetic Vaporization Procedure: Ejaculation Preserving Transurethral Resection Of The Prostate Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 84 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : March 10, 2018
Estimated Primary Completion Date : June 1, 2019
Estimated Study Completion Date : December 1, 2019

Arm Intervention/treatment
Active Comparator: Photoselective Vaporization Procedure: Ejaculation Preserving Photoselective Vaporization
Ejaculation Preserving Photoselective Vaporization

Active Comparator: Plasma Kinetic Vaporization Procedure: Ejaculation Preserving Plasma Kinetic Vaporization
Ejaculation Preserving Plasma Kinetic Vaporization

Active Comparator: Transurethral Resection Of The Prostate Procedure: Ejaculation Preserving Transurethral Resection Of The Prostate
Ejaculation Preserving Transurethral Resection Of The Prostate




Primary Outcome Measures :
  1. estimate and compare the ejaculation preservation effect of the 3 techniques (PKVP, PVP and TURP). [ Time Frame: 1 years ]
    assessed by Male Sexual Health Questionnaire (MSHQ)


Secondary Outcome Measures :
  1. change in flow rate [ Time Frame: 1 years ]
    measured by uroflowmetery in ml/sec

  2. postoperative complication [ Time Frame: 1 year ]
    measured by Clavien-Dindo Classification scale

  3. change in patients' symptoms. [ Time Frame: 1 year ]
    measured by International Prostate Symptom Score (I-PSS)



Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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:

  1. Bleeding disorders and patients on anticoagulant treatment
  2. Histologically proved cancer prostate
  3. Neurogenic voiding dysfunction
  4. Lower urinary tract malignancy
  5. Preoperative ejaculation or sexual dysfunction
  6. Presence of stricture urethra
  7. Unfit for spinal anathesia -

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03589196


Locations
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Egypt
Urology & Nephrology Center
Mansourah, Egypt
Sponsors and Collaborators
Mansoura University

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Responsible Party: Mansoura University
ClinicalTrials.gov Identifier: NCT03589196    
Other Study ID Numbers: MS/18.02.30
First Posted: July 17, 2018    Key Record Dates
Last Update Posted: July 17, 2018
Last Verified: March 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Prostatic Hyperplasia
Prostatic Diseases
Hyperplasia
Pathologic Processes
Genital Diseases, Male