Clinical trial NCT02984592: Effect of Exercise on Premature Ejaculation
Official title: Regular Physical Activity Improves Ejaculation Time and Patient-reported Outcomes
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Premature Ejaculation
Keywords: premature ejaculation
intravaginal ejaculatory latency time
premature ejaculation diagnostic tools
Lead sponsor: Ankara Training and Research Hospital
Sponsor class: OTHER
First posted: 2016-12-07
Enrollment: 50
Sex: MALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
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).

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: intravaginal ejaculatory latency time
timeFrame: 1 month
Secondary outcomes:
measure: Premature ejaculation diagnostic tool score
timeFrame: 1 month
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Ankara Training and Research Hospital
Study officials:
References:
citation: 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.
citation: 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.