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

July 4, 2018 updated by: Mansoura University

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

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

84

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Mansourah, Egypt
        • Urology & Nephrology Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

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 -

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
1 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
change in flow rate
Time Frame: 1 years
measured by uroflowmetery in ml/sec
1 years
postoperative complication
Time Frame: 1 year
measured by Clavien-Dindo Classification scale
1 year
change in patients' symptoms.
Time Frame: 1 year
measured by International Prostate Symptom Score (I-PSS)
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mansoura University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

March 10, 2018

Primary Completion (ANTICIPATED)

June 1, 2019

Study Completion (ANTICIPATED)

December 1, 2019

Study Registration Dates

First Submitted

May 20, 2018

First Submitted That Met QC Criteria

July 4, 2018

First Posted (ACTUAL)

July 17, 2018

Study Record Updates

Last Update Posted (ACTUAL)

July 17, 2018

Last Update Submitted That Met QC Criteria

July 4, 2018

Last Verified

March 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MS/18.02.30

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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