- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02984592
Effect of Exercise on Premature Ejaculation
Regular Physical Activity Improves Ejaculation Time and Patient-reported Outcomes
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Premature ejaculation (PE) is the most frequent sexual dysfunction in males, and its prevalence has been reported as 21-33%. Currently, there are no universal criteria for the diagnosis, or treatment strategies or approaches for PE. Lack of observational studies directed to PE makes comprehension of this sexual dysfunction difficult. The common point for definition of PE is a short duration between penetration and ejaculation, little or no control on voluntary control of ejaculation, and annoying character and negative effect of this condition on the individual. There are various treatment methods since ejaculation physiology and neuroanatomy is not yet clearly demonstrated. According to neurobiological hypothesis of Waldinger, a dysfunction in the serotonin pathway of the central system such as serotonin-2C hyposensitivity and/or serotonin-1A receptor hypersensitivity is a possible cause of lifelong PE. These experimental animal models showed that serotonergic activity at hypothalamic level inhibited ejaculation reflex. Based on this physiological effect, selective serotonin reuptake inhibitors (SSRI), and serotonin agonists increase intravaginal ejaculation latency time (IELT). A number of studies showed that exercise increased the functional effect of serotonin in the human brain.
The effects of physical activity level on human health have attracted interest worldwide. Lack of physical activity forms the basis of various health problems, however regular physical act contributes prevention and treatment of a number of disorders.
In current study, investigators will compare the ejaculation control, IELT, and prevalence of PE between sportsmen that have regular physical activity, and the individuals with a sedentary lifestyle.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Ankara, Turkey, 06340
- Ankara Training and Research Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- 18-45-year-old
- sexually active
- heterosexual,without erectile dysfunction
- sexual partner for at least six months, and sexual intercourse at least twice a week
Exclusion Criteria:
- chronic systemic disorders (such as diabetes or hypertension)
- use of narcotic/hypnotic drugs or stimulants
- anabolic steroids
- selective serotonin receptors inhibitors
- previous diagnosis and treatment for PE
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Cross-Sectional
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
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Group 1
The participants in group 1 will state that they participate regular exercise programs in the previous 6 months
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regular exercise programs in the previous 6 months.
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Group 2
The participants in group 2 will state that they do not perform any regular exercise in previous 6 months.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
intravaginal ejaculatory latency time
Time Frame: 1 month
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IELT value (second) according to the duration determined by the sexual partner with stopwatch method
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1 month
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Premature ejaculation diagnostic tool score
Time Frame: 1 month
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Premature Ejaculation Diagnostic Tool (PEDT) includes five items; control, frequency, minimal stimulation, distress, and interpersonal difficulty.
In this classification tool, score 8 indicates no premature ejaculation, scores 9 and 10 indicate possible premature ejaculation, and scores equal or higher than 11 indicates premature ejaculation.
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1 month
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Collaborators and Investigators
Publications and helpful links
General Publications
- Pastore AL, Palleschi G, Leto A, Pacini L, Iori F, Leonardo C, Carbone A. A prospective randomized study to compare pelvic floor rehabilitation and dapoxetine for treatment of lifelong premature ejaculation. Int J Androl. 2012 Aug;35(4):528-33. doi: 10.1111/j.1365-2605.2011.01243.x. Epub 2012 Feb 9.
- Pastore AL, Palleschi G, Fuschi A, Maggioni C, Rago R, Zucchi A, Costantini E, Carbone A. Pelvic floor muscle rehabilitation for patients with lifelong premature ejaculation: a novel therapeutic approach. Ther Adv Urol. 2014 Jun;6(3):83-8. doi: 10.1177/1756287214523329.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 5006
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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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