Premature Ejaculation
Conditions
Keywords
intravaginal ejaculatory latency time, international physical activity questionnaire, premature ejaculation diagnostic tool
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.
Interventions
BEHAVIORALphysical 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
DRUGdapoxetine 30 mg on demand
Dapoxetine, a short-acting selective serotonin reuptake inhibitors, has been utilized for the treatment of premature ejaculation in various countries
Sponsors
Ankara Training and Research Hospital
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
MALE
Age
18 Years to 40 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Premature Ejaculation Diagnostic Tool (Total Score) | 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. |
| Intravaginal Ejaculatory Latency Time | 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) |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 35 |
| 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 | 35 |
| 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 | 35 |
| Total | 105 |
Baseline characteristics
| Characteristic | Group 1 | Group 2 | Sham-controlled | Total |
|---|---|---|---|---|
| Age, Categorical Male <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Male >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Male Between 18 and 65 years | 35 Participants | 35 Participants | 35 Participants | 105 Participants |
| Race and Ethnicity Not Collected | — | — | — | 0 Participants |
| Region of Enrollment Turkey | 35 count of participants | 35 count of participants | 35 count of participants | 105 count of participants |
| Sex/Gender, Customized Male | 35 Participants | 35 Participants | 35 Participants | 105 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 35 | 0 / 35 | 0 / 35 |
| other Total, other adverse events | 0 / 35 | 0 / 35 | 0 / 35 |
| serious Total, serious adverse events | 0 / 35 | 0 / 35 | 0 / 35 |
Outcome results
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)
Time frame: Baseline and 30 Days
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Group 1 | Intravaginal Ejaculatory Latency Time | baseline data | 36.8 seconds | Standard Deviation 13.1 |
| Group 1 | Intravaginal Ejaculatory Latency Time | end of study data | 181.7 seconds | Standard Deviation 88.8 |
| Group 2 | Intravaginal Ejaculatory Latency Time | baseline data | 39.3 seconds | Standard Deviation 8.8 |
| Group 2 | Intravaginal Ejaculatory Latency Time | end of study data | 188.6 seconds | Standard Deviation 82.9 |
| Sham-controlled | Intravaginal Ejaculatory Latency Time | baseline data | 33.8 seconds | Standard Deviation 14.7 |
| Sham-controlled | Intravaginal Ejaculatory Latency Time | end of study data | 50.3 seconds | Standard Deviation 19.1 |
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.
Time frame: Baseline and 30 Days
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Group 1 | Premature Ejaculation Diagnostic Tool (Total Score) | baseline data | 14.5 scores on a scale | Standard Deviation 1.9 |
| Group 1 | Premature Ejaculation Diagnostic Tool (Total Score) | end of study data | 8.9 scores on a scale | Standard Deviation 2.5 |
| Group 2 | Premature Ejaculation Diagnostic Tool (Total Score) | baseline data | 13.7 scores on a scale | Standard Deviation 1.8 |
| Group 2 | Premature Ejaculation Diagnostic Tool (Total Score) | end of study data | 7.8 scores on a scale | Standard Deviation 2.9 |
| Sham-controlled | Premature Ejaculation Diagnostic Tool (Total Score) | baseline data | 13.7 scores on a scale | Standard Deviation 2.2 |
| Sham-controlled | Premature Ejaculation Diagnostic Tool (Total Score) | end of study data | 12.8 scores on a scale | Standard Deviation 1.7 |