The Impact and Benefit of Physical Activity on Premature Ejaculation

Study Overview
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Brief Summary
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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.

Official Title
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The Impact and Benefit of Physical Activity on Premature Ejaculation: Results of a Prospective, Randomized, Placebo-controlled Trial

Conditions
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Premature Ejaculation

Intervention / Treatment
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* Behavioral: physical activity
* Drug: dapoxetine 30 mg on demand


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Dapoxetine 30 mg<br>Patients who have sedentary life style will treat with Dapoxetine 30 mg (on demand) | Drug: dapoxetine 30 mg on demand<br>* Dapoxetine, a short-acting selective serotonin reuptake inhibitors, has been utilized for the treatment of premature ejaculation in various countries<br>|
| Experimental: Moderate Running<br>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<br>* patients will do moderate running which make them breathe somewhat harder than normal for at least 30 minutes for 5 days in a week<br>|
| Sham Comparator: Sham-controlled<br>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<br>* patients will do moderate running which make them breathe somewhat harder than normal for at least 30 minutes for 5 days in a week<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Baseline and 30 Days | 
| 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) | Baseline and 30 Days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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intravaginal ejaculatory latency time, international physical activity questionnaire, premature ejaculation diagnostic tool