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

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ClinicalTrials.gov Identifier: NCT02844998
Recruitment Status : Completed
First Posted : July 26, 2016
Results First Posted : September 29, 2017
Last Update Posted : September 29, 2017
Sponsor:
Information provided by (Responsible Party):
Muhammet Fatih Kilinc, Ankara Training and Research Hospital

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.

Condition or disease Intervention/treatment Phase
Premature Ejaculation Behavioral: physical activity Drug: dapoxetine 30 mg on demand Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: The Impact and Benefit of Physical Activity on Premature Ejaculation: Results of a Prospective, Randomized, Placebo-controlled Trial
Study Start Date : January 2015
Actual Primary Completion Date : May 2016
Actual Study Completion Date : July 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Dapoxetine 30 mg
Patients who have sedentary life style will treat with Dapoxetine 30 mg (on demand)
Drug: dapoxetine 30 mg on demand
Dapoxetine, a short-acting selective serotonin reuptake inhibitors, has been utilized for the treatment of premature ejaculation in various countries

Experimental: Moderate Running
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)
Behavioral: physical activity
patients will do moderate running which make them breathe somewhat harder than normal for at least 30 minutes for 5 days in a week

Sham Comparator: Sham-controlled
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)
Behavioral: physical activity
patients will do moderate running which make them breathe somewhat harder than normal for at least 30 minutes for 5 days in a week




Primary Outcome Measures :
  1. Premature Ejaculation Diagnostic Tool (Total Score) [ Time Frame: Baseline and 30 Days ]
    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.

  2. Intravaginal Ejaculatory Latency Time [ Time Frame: Baseline and 30 Days ]
    Duration determined by the sexual partner with stopwatch method, and <1 minute was considered as PE. (minimum/maximum scores were not possible)



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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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.

Publications:
Responsible Party: Muhammet Fatih Kilinc, M.D., Ankara Training and Research Hospital
ClinicalTrials.gov Identifier: NCT02844998     History of Changes
Other Study ID Numbers: 5191
First Posted: July 26, 2016    Key Record Dates
Results First Posted: September 29, 2017
Last Update Posted: September 29, 2017
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

Keywords provided by Muhammet Fatih Kilinc, Ankara Training and Research Hospital:
intravaginal ejaculatory latency time
international physical activity questionnaire
premature ejaculation diagnostic tool

Additional relevant MeSH terms:
Premature Birth
Premature Ejaculation
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications
Sexual Dysfunction, Physiological
Genital Diseases, Male
Sexual Dysfunctions, Psychological
Mental Disorders