PE: The Impact and Benefit of Physical Activity on Premature Ejaculation

• Sponsor: Ankara Training and Research Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT02844998
• Collaborator: (none)
• Enrollment: 120
• Arms: 3
• Duration (Months): 18

Study Details

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	N/A

Study Design

• Study Type: Interventional
• 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: Jan 1, 2015
• Actual Primary Completion Date: May 1, 2016
• Actual Study Completion Date: Jul 1, 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) [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 [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

Criteria

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

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

Locations

No locations specified.

Sponsors and Collaborators

• Ankara Training and Research Hospital

Investigators

None specified.

Study Documents (Full-Text)

None 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.
• 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.
• 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.

• Responsible Party: Muhammet Fatih Kilinc, M.D., Ankara Training and Research Hospital
• ClinicalTrials.gov Identifier: NCT02844998
• Other Study ID Numbers: 5191
• First Posted: Jul 26, 2016
• Last Update Posted: Sep 29, 2017
• Last Verified: Sep 1, 2017

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Keywords provided by Muhammet Fatih Kilinc, M.D., 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

Study Results

Participant Flow

Arm/Group Title	Group 1	Group 2	Sham-controlled
Arm/Group Description	Patients who have sedentary life style will treat with Dapoxetine 30 mg (on demand) 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	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. 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 (To increase the physical activity level to "minimally active category or moderate physical activities [600-3,000 MET-min/week] according to IPAQ classification)	Patients who have sedentary life style will be advised those to walk at most 30 minutes for 5 days in a week. 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. (inactive category [<600 MET-min/week] according to the IPAQ classification)
Period Title: Overall Study
STARTED	42	39	39
COMPLETED	35	35	35
NOT COMPLETED	7	4	4

Baseline Characteristics

Arm/Group Title	Group 1	Group 2	Sham-controlled	Total
Arm/Group Description	Patients who have sedentary life style will treat with Dapoxetine 30 mg (on demand) 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	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 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	Patients who have sedentary life style will be advised those to walk at most 30 minutes for 5 days in a week. 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	Total of all reporting groups
Overall Participants	35	35	35	105
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%	0 0%
Between 18 and 65 years	35 100%	35 100%	35 100%	105 100%
>=65 years	0 0%	0 0%	0 0%	0 0%
Sex/Gender, Customized (Count of Participants)
Male	35 100%	35 100%	35 100%	105 100%
Race and Ethnicity Not Collected (Count of Participants)
Count of Participants [Participants]	0 0%
Region of Enrollment (count of participants) [Number]
Turkey	35 100%	35 100%	35 100%	105 100%

Outcome Measures

1. Primary Outcome

Title	Premature Ejaculation Diagnostic Tool (Total Score)
Description	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.
Time Frame	Baseline and 30 Days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Group 1	Group 2	Sham-controlled
Arm/Group Description	Patients who have sedentary life style will treat with Dapoxetine 30 mg (on demand) 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	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. 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 (To increase the physical activity level to "minimally active category or moderate physical activities [600-3,000 MET-min/week] according to IPAQ classification)	Patients who have sedentary life style will be advised those to walk at most 30 minutes for 5 days in a week. 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. (inactive category [<600 MET-min/week] according to the IPAQ classification)
Measure Participants	35	35	35
baseline data	14.5 (1.9)	13.7 (1.8)	13.7 (2.2)
end of study data	8.9 (2.5)	7.8 (2.9)	12.8 (1.7)

2. Primary Outcome

Title	Intravaginal Ejaculatory Latency Time
Description	Duration determined by the sexual partner with stopwatch method, and <1 minute was considered as PE. (minimum/maximum scores were not possible)
Time Frame	Baseline and 30 Days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Group 1	Group 2	Sham-controlled
Arm/Group Description	Patients who have sedentary life style will treat with Dapoxetine 30 mg (on demand) 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	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. 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 (To increase the physical activity level to "minimally active category or moderate physical activities [600-3,000 MET-min/week] according to IPAQ classification)	Patients who have sedentary life style will be advised those to walk at most 30 minutes for 5 days in a week. 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. (inactive category [<600 MET-min/week] according to the IPAQ classification)
Measure Participants	35	35	35
baseline data	36.8 (13.1)	39.3 (8.8)	33.8 (14.7)
end of study data	181.7 (88.8)	188.6 (82.9)	50.3 (19.1)

Adverse Events

Arm/Group Title	Group 1		Group 2		Sham-controlled
Arm/Group Description	Patients who have sedentary life style will treat with Dapoxetine 30 mg (on demand) 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		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 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		Patients who have sedentary life style will be advised those to walk at most 30 minutes for 5 days in a week. 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
All Cause Mortality
	Group 1		Group 2		Sham-controlled
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/35 (0%)		0/35 (0%)		0/35 (0%)
Serious Adverse Events
	Group 1		Group 2		Sham-controlled
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/35 (0%)		0/35 (0%)		0/35 (0%)
Other (Not Including Serious) Adverse Events
	Group 1		Group 2		Sham-controlled
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/35 (0%)		0/35 (0%)		0/35 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.