- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05964608
The Effect of Behavioral Therapy Given to Men and Their Partners'
The Effect of Behavioral Therapy Given to Men With Premature Ejaculation on Symptoms and Their Partners' Sexual Functioning and Sexual Quality of Life
Study Overview
Status
Intervention / Treatment
Detailed Description
Introduction and hypothesis: Premature ejaculation potentially affects not only men but also their partners negatively. The null hypothesis for this study is Behavioral therapy given to men with premature ejaculation has no effect on the symptoms and their partners' sexual functions and quality of sexual life.
Methods: A quasi-experimental study. The current study was conducted in 84 men and their partners. The "Personal Information Form", "Premature Ejaculation Diagnostic Tool (PEDT)", "Female Sexual Function Index (FSFI)", and "Sexual Quality of Life-Female (SQOL-F)" were used to collect data. Behavioral therapy, consisting of a total of 6 sessions of 45 minutes, was applied once every two weeks.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Gaziantep, Turkey, 0027
- ECE
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Willingness to participate
- Having no communication barriers
- Literacy
- Age 18-45 years
- Having no diagnosis of sexual dysfunctions
- Having no medical illnesses (psychiatric diseases, pelvic anatomical disorder, post-menopause, etc.) that might affect the sexual function
- Having a spouse diagnosed with premature ejaculation according to DSM-5 criteria
- Having a spouse without any prior behavioral therapy for premature ejaculation
- Being a man diagnosed with lifelong premature ejaculation according to the ISSM criteria.
- Being married
Exclusion Criteria:
-Men and their partners who did not meet all inclusion criteria were excluded from the present study.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Treatment group
Pre-tests were applied to the men (Personal Information Form and PEDT) and their spouses (Personal Information Form, FSFI, and SQOL-F) just before the behavioral treatment was applied to the men in the treatment group.
In the first interview with the men, the researchers delivered information about behavioral therapy and set therapy days and hours.
Structured interviews, consisting of a total of 6 sessions, were held once every two weeks for men with premature ejaculation problems.
Behavioral therapy took place once every two weeks for a total of six 45-minute sessions.
The "stop-start technique" was the therapy used.
Behavioral therapy interviews were conducted at the urology outpatient clinic of the hospital.
Post-tests were administered to men with premature ejaculation (PEDT) and their spouses (FSFI and SQOL-F) immediately after the 6th session was completed.
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Structured interviews, consisting of a total of 6 sessions, were held once every two weeks for men with premature ejaculation problems.
Behavioral therapy took place once every two weeks for a total of six 45-minute sessions.
The "stop-start technique" was the therapy used.
Behavioral therapy interviews were conducted at the urology outpatient clinic of the hospital.
Post-tests were administered to men with premature ejaculation (PEDT) and their spouses (FSFI and SQOL-F) immediately after the 6th session was completed.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Premature Ejaculation Diagnostic Tool (PEDT)
Time Frame: six weeks
|
it was developed by Symonds et al. (2007) to better define premature ejaculation for use in clinical studies, this is a 5-point Likert-type scale consisting of 5 items.
The scale was adapted to Turkish by Serefoglu et al. (2009).
The highest score that can be obtained from the scale is 20.0 and the lowest score is 0.0.
Scores higher than 11 are defined as "PE", scores of 9-10 are defined as "possible PE", and scores of eight or less are defined as "no PE".
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six weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Female Sexual Function Index (FSFI)
Time Frame: six weeks
|
Developed by Rosen et al. in 2000, the Female Sexual Function Index (FSFI) is a multidimensional scale consisting of six sections and 19 items evaluating female sexual function.
The scale was adapted to Turkish by Aygin and Eti Aslan (2005).
The scale contains six sub-dimensions: desire, arousal, lubrication (wetting), orgasm, satisfaction, and pain.
The highest score that can be obtained from the scale is 36.0 and the lowest is 2.0.
As the score obtained from the scale increases, sexual function improves.
The simple mathematical algorithm calculation is organized to determine the scoring of the subscales and the entire scale.
Factor loads were determined as 0.6 for desire, 0.3 for arousal and lubrication, and 0.4 for orgasm, satisfaction, and pain.
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six weeks
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Sexual Quality of Life-Female (SQOL-F)
Time Frame: six weeks
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It was developed by Symonds et al. in 2005, the Sexual Quality of Life-Female (SQOL-F) is a six-point Likert-type questionnaire consisting of 18 items to evaluate women's sexual quality of life.
Tugut and Golbasi (2010) adapted the questionnaire to Turkish in 2010.
Each item addresses sexual life over the preceding four weeks.
The questionnaire uses a 1-6 point system (1-totally agree, 2-strongly agree, 3-somewhat disagree, 5-strongly disagree, 6-totally disagree), and the range of points that can be obtained is between 18 and 108.
As the score obtained from the questionnaire increases, the quality of sexual life increases.
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six weeks
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Kazım Doğan, Dr., Istinye Üniversity
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Mental Disorders
- Pregnancy Complications
- Obstetric Labor Complications
- Sexual Dysfunctions, Psychological
- Obstetric Labor, Premature
- Sexual Dysfunction, Physiological
- Female Urogenital Diseases and Pregnancy Complications
- Urogenital Diseases
- Male Urogenital Diseases
- Genital Diseases, Male
- Genital Diseases
- Premature Birth
- Premature Ejaculation
Other Study ID Numbers
- GAUN-EBE-EK-01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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