The Impact and Benefit of Physical Activity on Premature Ejaculation

Not Applicable

Completed

• Conditions: Premature Ejaculation
• Interventions: Drug: dapoxetine 30 mg on demand; Behavioral: physical activity

• Registration Number: NCT02844998
• Lead Sponsor: Ankara Training and Research Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-01
• Primary Completion: 2016-05
• Study Completion: 2016-07
• Study First Submitted: 2016-07-13
• Study First Submitted QC: 2016-07-25
• Study First Posted: 2016-07-26
• Results First Submitted: 2017-07-06
• Status Verified: 2017-09
• Results First Submitted QC: 2017-09-04
• Last Update Submitted: 2017-09-04
• Results First Posted: 2017-09-29
• Last Update Posted: 2017-09-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 120

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Dapoxetine 30 mg	dapoxetine 30 mg on demand	Patients who have sedentary life style will treat with Dapoxetine 30 mg (on demand)
Moderate Running	physical activity	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)
Sham-controlled	physical activity	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)

Primary Outcome Measures

Name	Time	Method
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)