The Impact and Benefit of Physical Activity on Premature Ejaculation

NCT02844998 | Completed Results DMC

• 1 other identifier: 5191
• Study Type: interventional
• Target: 120
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Premature Ejaculation

Keywords

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

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (3)

Dapoxetine 30 mg

ACTIVE COMPARATOR

Patients who have sedentary life style will treat with Dapoxetine 30 mg (on demand)

Drug: 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)

Behavioral: physical activity

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)

Behavioral: physical activity

Interventions

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

Moderate Running; Sham-controlled

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

Dapoxetine 30 mg

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ankara Training and Research Hospital: lead

Related Publications (3)

• 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.

  PMID: 12900694 BACKGROUND

• 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.

  PMID: 17275165 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.

  PMID: 21256670 BACKGROUND

MeSH Terms

Conditions

Premature Ejaculation

Interventions

Exercise; dapoxetine

Condition Hierarchy (Ancestors)

Ejaculatory Dysfunction; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Sexual Dysfunction, Physiological; Male Urogenital Diseases; Sexual Dysfunctions, Psychological; Mental Disorders

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Results Point of Contact

• Title: Dr. Muhammet Fatih Kilinc
• Organization: Ankara TRH

mdfatihkilinc@yahoo.com

+90 312 595 3700

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D.

Study Record Dates

• First Submitted: July 13, 2016
• First Posted: July 26, 2016
• Study Start: January 1, 2015
• Primary Completion: May 1, 2016
• Study Completion: July 1, 2016
• Last Updated: September 29, 2017
• Results First Posted: September 29, 2017

Record last verified: 2017-09

Data Sharing

• IPD Sharing: Will share