Premature EjaculationNCT02984592
Effect of Exercise on Premature Ejaculation
An observational study of Premature Ejaculation, run by Ankara Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
Premature ejaculation (PE) is one of the prevalent disorders in men; its leading sequel such as lack of self-confidence, anxiety, depression and unsatisfactory intercourse in men and their partners. The current study was aimed to evaluate the relationship between ejaculation and physical activity. Read more about this study
- Who is it for?
- Ages 18 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Premature Ejaculation
- What is being tested?
- physical exercise
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 50 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Nov 2016to 31 Jan 2017
- How long will I take part?
- 1 Month
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Men only
- Healthy volunteers accepted
- Adult
Study population: The participants are 18-45 year-old, and have regular sexual activity for at least 6 months. A comparison was made by metabolic equivalents (MET), premature ejaculation diagnostic tool (PEDT) and intravaginal ejaculatory latency time (IELT).
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Ankara Training and Research Hospital
Ankara, 06340
About this study
Official title: Regular Physical Activity Improves Ejaculation Time and Patient-reported Outcomes
Premature ejaculation (PE) is one of the prevalent disorders in men; its leading sequel such as lack of self-confidence, anxiety, depression and unsatisfactory intercourse in men and their partners. The current study was aimed to evaluate the relationship between ejaculation and physical activity.
Read the 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.
- Conditions
- Premature Ejaculation
- Being tested
- physical exercise
- Keywords
- premature ejaculation, intravaginal ejaculatory latency time, premature ejaculation diagnostic tools
- Medical subject headings
- Premature Ejaculation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
physical exerciseBehavioural
regular exercise programs in the previous 6 months.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | The participants in group 1 will state that they participate regular exercise programs in the previous 6 months Receives: Behavioral: physical exercise | |
| Group 2 | The participants in group 2 will state that they do not perform any regular exercise in previous 6 months. |
What is being measured
The primary outcome is the main question the study is designed to answer.
intravaginal ejaculatory latency time
IELT value (second) according to the duration determined by the sexual partner with stopwatch method
Measured: 1 month
Secondary outcomes (1)
Premature ejaculation diagnostic tool score
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.
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2016 (estimated)
- Study startNov 2016
- Primary completion31 Jan 2017
- Study completion31 Jan 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Premature EjaculationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 50 participants (actual)
- Target duration
- 1 Month
Sponsor and investigators
- Lead sponsor
- Ankara Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Muhammet Fatih Kilinc, Ankara Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02984592
- Sponsor's protocol ID
- 5006
- Status last verified
- Feb 2017
- First submitted
- 1 Dec 2016
- Last updated
- 3 Feb 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes
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.
PubMed 22320846Pastore 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.
PubMed 24883105
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Regular Physical Activity Improves Ejaculation Time and Patient-reported Outcomes
- ClinicalTrials.gov ID
- NCT02984592
- Acronym / sponsor ID
- 5006
- Conditions
- Premature Ejaculation
- Keywords
- premature ejaculation, intravaginal ejaculatory latency time, premature ejaculation diagnostic tools
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Ankara Training and Research HospitalUniversity, hospital or other
- Study start
- Nov 2016
- Primary completion
- 31 Jan 2017 (actual)
- Study completion
- 31 Jan 2017 (actual)
- First posted
- 7 Dec 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Premature ejaculation (PE) is one of the prevalent disorders in men; its leading sequel such as lack of self-confidence, anxiety, depression and unsatisfactory intercourse in men and their partners. The current study was aimed to evaluate the relationship between ejaculation and physical activity.
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 design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Month
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | Behavioral: physical exerciseThe participants in group 1 will state that they participate regular exercise programs in the previous 6 months |
| Group 2 | – | –The participants in group 2 will state that they do not perform any regular exercise in previous 6 months. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- The participants are 18-45 year-old, and have regular sexual activity for at least 6 months. A comparison was made by metabolic equivalents (MET), premature ejaculation diagnostic tool (PEDT) and intravaginal ejaculatory latency time (IELT).
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| physical exerciseregular exercise programs in the previous 6 months. | Behavioural | Group 1 |
Primary outcome
intravaginal ejaculatory latency time
Time frame: 1 month
IELT value (second) according to the duration determined by the sexual partner with stopwatch method
1 secondary outcome
Premature ejaculation diagnostic tool score
Time frame: 1 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2017.
- Results publication: PubMed 22320846Pastore 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.
- Results publication: PubMed 24883105Pastore 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.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Premature Ejaculation, run by Ankara Training and Research Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
intravaginal ejaculatory latency time (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02984592, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Feb 2017.