The Impact and Benefit of Physical Activity on Premature Ejaculation (PE)

• ClinicalTrials.gov Identifier: NCT02844998
• Recruitment Status: Completed
• First Posted: July 26, 2016
• Results First Posted: September 29, 2017
• Last Update Posted: September 29, 2017
• Sponsor: Ankara Training and Research Hospital
• Information provided by (Responsible Party): Muhammet Fatih Kilinc, Ankara Training and Research Hospital

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Premature Ejaculation	Behavioral: physical activity; Drug: dapoxetine 30 mg on demand	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 120 participants
• Allocation: Randomized
• Intervention Model: Single Group Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: The Impact and Benefit of Physical Activity on Premature Ejaculation: Results of a Prospective, Randomized, Placebo-controlled Trial
• Study Start Date: January 2015
• Actual Primary Completion Date: May 2016
• Actual Study Completion Date: July 2016

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: Dapoxetine 30 mg; Patients who have sedentary life style will treat with Dapoxetine 30 mg (on demand)	Drug: 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
Experimental: Moderate Running; 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)	Behavioral: 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
Sham Comparator: Sham-controlled; 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)	Behavioral: 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

Outcome Measures

Primary Outcome Measures :

1. Premature Ejaculation Diagnostic Tool (Total Score) [ Time Frame: 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.
2. Intravaginal Ejaculatory Latency Time [ Time Frame: 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)

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 40 Years (Adult)
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: Yes

Criteria

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.

Contacts and Locations

No Contacts or Locations Provided

More Information

Publications:

Craig CL, Marshall AL, Sjöström 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.

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. Epub 2007 Jan 16.

Sunay D, Sunay M, Aydoğmuş Y, Bağbancı 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.

• Responsible Party: Muhammet Fatih Kilinc, M.D., Ankara Training and Research Hospital
• ClinicalTrials.gov Identifier: NCT02844998
• Other Study ID Numbers: 5191
• First Posted: July 26, 2016
• Results First Posted: September 29, 2017
• Last Update Posted: September 29, 2017
• Last Verified: September 2017

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Yes

Keywords provided by Muhammet Fatih Kilinc, Ankara Training and Research Hospital:

intravaginal ejaculatory latency time; international physical activity questionnaire; premature ejaculation diagnostic tool

Additional relevant MeSH terms:

Premature Birth; Premature Ejaculation; Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Sexual Dysfunction, Physiological; Sexual Dysfunctions, Psychological; Mental Disorders