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Ejaculatory Sparing vs. Non-ejaculatory Sparing GreenLight Laser Photoselective Vaporization of the Prostate

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ClinicalTrials.gov Identifier: NCT02749604
Recruitment Status : Unknown
Verified April 2016 by Ahmed Elshal, Mansoura University.
Recruitment status was:  Recruiting
First Posted : April 25, 2016
Last Update Posted : April 25, 2016
Sponsor:
Information provided by (Responsible Party):
Ahmed Elshal, Mansoura University

Brief Summary:
GreenLight laser PVP currently gains wide acceptance as a minimally invasive treatment for benign prostate enlargment and the emergence of ejaculatory sparing techniques made it feasible to get both benefits: relief of lower urinary tract symptoms and preservation of ejaculation. However evaluation of actual infravesical de-obstruction following such techniques remains a grey zone in the literature without an objective assessment of the degree of de-obstruction. Furthermore, the impact of maintaining ejaculation on different domains of the sexual function using comprehensive assessment tools was not compared in ejaculatory sparring vs. non-ejaculatory sparring approaches.

Condition or disease Intervention/treatment Phase
Prostatic Hyperplasia Procedure: Non-ejaculatory sparring PVP Procedure: Ejaculatory sparring PVP Phase 4

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Ejaculatory Sparing vs. Non-ejaculatory Sparing GreenLightTM Laser Photoselective Vaporization of the Prostate (PVP): A Randomized Double Blind Sexual and Urodynamic Assessment
Study Start Date : March 2016
Estimated Primary Completion Date : September 2017
Estimated Study Completion Date : March 2018

Arm Intervention/treatment
Active Comparator: Non-ejaculatory sparring PVP
Greenlight laser photoslective vaporization of the prostate
Procedure: Non-ejaculatory sparring PVP
Greenlight laser photoslective vaporization of the prostate

Experimental: Ejaculatory sparring PVP
Greenlight laser photoslective vaporization of the prostate with preservation of the ejaculatory hood
Procedure: Ejaculatory sparring PVP
Greenlight laser photoslective vaporization of the prostate with preservation of the ejaculatory hood




Primary Outcome Measures :
  1. ejaculatory function [ Time Frame: 4 months ]
    the ability to maintain ejaculatory function as depicted by Ej-MSHQ score


Secondary Outcome Measures :
  1. Bladder outlet obstruction index [ Time Frame: 4 months ]
    Urodynamic study looking at the dynamics of urine flow for assessment of the degree of de-obstruction

  2. International index of erectile function-15 [ Time Frame: 4 months ]
    questionnaire assessing different aspects of sexual function



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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • To be eligible in the study, patient must fulfill the following criteria:

    1. Age ≥ 50 years
    2. ASA (American society of anesthesiologists) score ≤3.
    3. TRUS estimated prostate weight 30-80 grams.
    4. Sexually interested and having continuous relationship with the same partner (interested).
    5. BOOI (bladder outlet obstructing index) ≥ 20 as per pressure flow study

Exclusion Criteria:

  • Patients with any of the following are to be excluded:

    1. Preoperative sexual or ejaculatory disturbances or pelvic pain syndrome
    2. Documented or suspected prostate cancer (significantly elevated PSA, positive biopsy for prostate cancer guided by TRUS)
    3. Neurological disorders that can affect potency and ejaculation e.g. long standing uncontrolled DM (> 10 years) cerebral stroke, Parkinsonism
    4. Active urinary tract infection
    5. Urodynamic changes consistent with urethropathy or detrusor hypocontractility
    6. Previous pelvic surgeries
    7. History of pelvic radiotherapy

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): NCT02749604


Contacts
Contact: Ahmed M Elshal, MD elshalam@hotmail.com
Contact: Ahmed alhussein ahmedalhussein20@gmail.com

Locations
Egypt
Urology and nephrology center Recruiting
Mansoura, DK, Egypt, 35516
Contact: Ahmed M Elshal, MD    +20502202222 ext 1643    elshalam@hotmail.com   
Contact: Elhussein Abolazm       ahmedalhussein20@gmail.com   
Sub-Investigator: Ahmed Elhussein Abolazm, MD         
Sponsors and Collaborators
Mansoura University
Investigators
Principal Investigator: Ahmed Elshal Mansoura Urology and Nephrology Center

Responsible Party: Ahmed Elshal, Dr, Mansoura University
ClinicalTrials.gov Identifier: NCT02749604     History of Changes
Other Study ID Numbers: Mans 4-5-2016
First Posted: April 25, 2016    Key Record Dates
Last Update Posted: April 25, 2016
Last Verified: April 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Additional relevant MeSH terms:
Hyperplasia
Prostatic Hyperplasia
Pathologic Processes
Prostatic Diseases
Genital Diseases, Male