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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dapoxetine 30 mg | Active Comparator | Patients who have sedentary life style will treat with Dapoxetine 30 mg (on demand) |
|
| Moderate Running | Experimental | 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) |
|
| Sham-controlled | Sham Comparator | 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) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| physical activity | Behavioral | patients will do moderate running which make them breathe somewhat harder than normal for at least 30 minutes for 5 days in a week |
|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 12900694 | Background | 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. | |
| 17275165 | Background |
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| ID | Title | Description |
|---|---|---|
| FG000 | Group 1 | Patients who have sedentary life style will treat with Dapoxetine 30 mg (on demand) 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 |
| FG001 | Group 2 | 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. 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 (To increase the physical activity level to "minimally active category or moderate physical activities [600-3,000 MET-min/week] according to IPAQ classification) |
| FG002 | Sham-controlled | Patients who have sedentary life style will be advised those to walk at most 30 minutes for 5 days in a week. 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. (inactive category [<600 MET-min/week] according to the IPAQ classification) |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Group 1 | Patients who have sedentary life style will treat with Dapoxetine 30 mg (on demand) 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 |
| BG001 | Group 2 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Mean | Standard Deviation | scores on a scale | Baseline and 30 Days |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Group 1 | Patients who have sedentary life style will treat with Dapoxetine 30 mg (on demand) 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 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Muhammet Fatih Kilinc | Ankara TRH | +90 312 595 3700 | 3724 | mdfatihkilinc@yahoo.com |
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| ID | Term |
|---|---|
| D061686 | Premature Ejaculation |
| ID | Term |
|---|---|
| D000097910 | Ejaculatory Dysfunction |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
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| ID | Term |
|---|---|
| D015444 | Exercise |
| C080598 | dapoxetine |
| ID | Term |
|---|---|
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
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| dapoxetine 30 mg on demand | Drug | Dapoxetine, a short-acting selective serotonin reuptake inhibitors, has been utilized for the treatment of premature ejaculation in various countries |
|
| 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. |
| 21256670 | Background | 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. |
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 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 |
| BG002 | Sham-controlled | Patients who have sedentary life style will be advised those to walk at most 30 minutes for 5 days in a week. 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 |
| BG003 | Total | Total of all reporting groups |
| Participants |
| No |
|
| Sex/Gender, Customized | Count of Participants | Participants | No |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | All participitants are male | Number | count of participants |
|
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. 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 (To increase the physical activity level to "minimally active category or moderate physical activities [600-3,000 MET-min/week] according to IPAQ classification) |
| OG002 | Sham-controlled | Patients who have sedentary life style will be advised those to walk at most 30 minutes for 5 days in a week. 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. (inactive category [<600 MET-min/week] according to the IPAQ classification) |
|
|
| Primary | 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) | Posted | Mean | Standard Deviation | seconds | Baseline and 30 Days |
|
|
|
| 0 |
| 35 |
| 0 |
| 35 |
| 0 |
| 35 |
| EG001 | Group 2 | 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 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 | 0 | 35 | 0 | 35 | 0 | 35 |
| EG002 | Sham-controlled | Patients who have sedentary life style will be advised those to walk at most 30 minutes for 5 days in a week. 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 | 0 | 35 | 0 | 35 | 0 | 35 |
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| D012735 | Sexual Dysfunction, Physiological |
| D052801 | Male Urogenital Diseases |
| D020018 | Sexual Dysfunctions, Psychological |
| D001523 | Mental Disorders |
| Between 18 and 65 years |
|
| >=65 years |
|
|