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The Impact and Benefit of Physical Activity on Premature Ejaculation (PE)

Primary Purpose

Premature Ejaculation

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
physical activity
dapoxetine 30 mg on demand
Sponsored by
Ankara Training and Research Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Premature Ejaculation focused on measuring intravaginal ejaculatory latency time, international physical activity questionnaire, premature ejaculation diagnostic tool

Eligibility Criteria

18 Years - 40 Years (Adult)MaleAccepts Healthy Volunteers

Inclusion Criteria:

  • Sexually active, heterosexual patients without regular physical activity or erectile dysfunction, and had a sexual partner for at least six months, and sexual intercourse at least twice a week

Exclusion Criteria:

  • Use of medications for endocrinological, metabolic, chronic systemic, or psychiatric diseases, use of alcohol or addictive substances, or use of drugs that might affect erection and ejaculation, presence of patients with Peyronie's disease, chronic prostatitis, urethritis, or active urinary tract infection, and absence of regular physical activity or previous treatment for premature ejaculation.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Active Comparator

    Experimental

    Sham Comparator

    Arm Label

    Dapoxetine 30 mg

    Moderate Running

    Sham-controlled

    Arm Description

    Patients who have sedentary life style will treat with Dapoxetine 30 mg (on demand)

    Patients who have sedentary life style will be advised moderate running which make them breathe somewhat harder than normal for at least 30 minutes for 5 days in a week. (Minimally active category)

    Patients who have sedentary life style will be advised those to walk (not running )at most 30 minutes for 5 days in a week. (Inactive category)

    Outcomes

    Primary Outcome Measures

    Premature Ejaculation Diagnostic Tool (Total Score)
    Premature Ejaculation Diagnostic Tool (PEDT) includes five items; control, frequency, minimal stimulation, distress, and interpersonal difficulty. In this classification tool, equal to or less than scores 8 indicates no PE, scores 9 and 10 indicate possible PE, and scores equal or higher than 11 indicates PE. Total score is between 2 and 22.
    Intravaginal Ejaculatory Latency Time
    Duration determined by the sexual partner with stopwatch method, and <1 minute was considered as PE. (minimum/maximum scores were not possible)

    Secondary Outcome Measures

    Full Information

    First Posted
    July 13, 2016
    Last Updated
    September 4, 2017
    Sponsor
    Ankara Training and Research Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02844998
    Brief Title
    The Impact and Benefit of Physical Activity on Premature Ejaculation
    Acronym
    PE
    Official Title
    The Impact and Benefit of Physical Activity on Premature Ejaculation: Results of a Prospective, Randomized, Placebo-controlled Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    January 2015 (undefined)
    Primary Completion Date
    May 2016 (Actual)
    Study Completion Date
    July 2016 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Ankara Training and Research Hospital

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    The purpose of this study is to investigate the relationship between physical activity and PE, and determine whether moderate physical activity might delay ejaculation time or be an alternative treatment for PE.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Premature Ejaculation
    Keywords
    intravaginal ejaculatory latency time, international physical activity questionnaire, premature ejaculation diagnostic tool

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    120 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Dapoxetine 30 mg
    Arm Type
    Active Comparator
    Arm Description
    Patients who have sedentary life style will treat with Dapoxetine 30 mg (on demand)
    Arm Title
    Moderate Running
    Arm Type
    Experimental
    Arm Description
    Patients who have sedentary life style will be advised moderate running which make them breathe somewhat harder than normal for at least 30 minutes for 5 days in a week. (Minimally active category)
    Arm Title
    Sham-controlled
    Arm Type
    Sham Comparator
    Arm Description
    Patients who have sedentary life style will be advised those to walk (not running )at most 30 minutes for 5 days in a week. (Inactive category)
    Intervention Type
    Behavioral
    Intervention Name(s)
    physical activity
    Intervention Description
    patients will do moderate running which make them breathe somewhat harder than normal for at least 30 minutes for 5 days in a week
    Intervention Type
    Drug
    Intervention Name(s)
    dapoxetine 30 mg on demand
    Intervention Description
    Dapoxetine, a short-acting selective serotonin reuptake inhibitors, has been utilized for the treatment of premature ejaculation in various countries
    Primary Outcome Measure Information:
    Title
    Premature Ejaculation Diagnostic Tool (Total Score)
    Description
    Premature Ejaculation Diagnostic Tool (PEDT) includes five items; control, frequency, minimal stimulation, distress, and interpersonal difficulty. In this classification tool, equal to or less than scores 8 indicates no PE, scores 9 and 10 indicate possible PE, and scores equal or higher than 11 indicates PE. Total score is between 2 and 22.
    Time Frame
    Baseline and 30 Days
    Title
    Intravaginal Ejaculatory Latency Time
    Description
    Duration determined by the sexual partner with stopwatch method, and <1 minute was considered as PE. (minimum/maximum scores were not possible)
    Time Frame
    Baseline and 30 Days

    10. Eligibility

    Sex
    Male
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    40 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Sexually active, heterosexual patients without regular physical activity or erectile dysfunction, and had a sexual partner for at least six months, and sexual intercourse at least twice a week Exclusion Criteria: Use of medications for endocrinological, metabolic, chronic systemic, or psychiatric diseases, use of alcohol or addictive substances, or use of drugs that might affect erection and ejaculation, presence of patients with Peyronie's disease, chronic prostatitis, urethritis, or active urinary tract infection, and absence of regular physical activity or previous treatment for premature ejaculation.

    12. IPD Sharing Statement

    Plan to Share IPD
    Yes
    Citations:
    PubMed Identifier
    12900694
    Citation
    Craig CL, Marshall AL, Sjostrom M, Bauman AE, Booth ML, Ainsworth BE, Pratt M, Ekelund U, Yngve A, Sallis JF, Oja P. International physical activity questionnaire: 12-country reliability and validity. Med Sci Sports Exerc. 2003 Aug;35(8):1381-95. doi: 10.1249/01.MSS.0000078924.61453.FB.
    Results Reference
    background
    PubMed Identifier
    17275165
    Citation
    Symonds T, Perelman MA, Althof S, Giuliano F, Martin M, May K, Abraham L, Crossland A, Morris M. Development and validation of a premature ejaculation diagnostic tool. Eur Urol. 2007 Aug;52(2):565-73. doi: 10.1016/j.eururo.2007.01.028. Epub 2007 Jan 16.
    Results Reference
    background
    PubMed Identifier
    21256670
    Citation
    Sunay D, Sunay M, Aydogmus Y, Bagbanci S, Arslan H, Karabulut A, Emir L. Acupuncture versus paroxetine for the treatment of premature ejaculation: a randomized, placebo-controlled clinical trial. Eur Urol. 2011 May;59(5):765-71. doi: 10.1016/j.eururo.2011.01.019. Epub 2011 Jan 18.
    Results Reference
    background

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    The Impact and Benefit of Physical Activity on Premature Ejaculation

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