An interventional study of Behavioral Therapy in Premature Ejaculation and Sexual Function Disturbances, sponsored by University of Gaziantep. Completed at 1 site in Turkey. Per ClinicalTrials.gov, last updated 2023-07-28.
Sponsored by University of Gaziantep · Not applicable, Interventional, and Treatment
Premature ejaculation involves not only sexual problems but also relationship and communication difficulties, and behavioral approaches to the treatment of premature ejaculation are promising.
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.
106 studies on the registry are indexed under Premature Ejaculation; 17 are open to participants now.
This study's enrollment of 84 is close to the median of 84 across 89 interventional studies indexed under Premature Ejaculation.
Browse Premature Ejaculation studies →University of Gaziantep is the lead sponsor of 105 studies on the registry; 28 are open to participants now.
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Exclusion Criteria:
-Men and their partners who did not meet all inclusion criteria were excluded from the present study.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Postmenopausal
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
DSM diagnostic criteria
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Behavioral: Behavioral Therapy
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.
Premature Ejaculation Diagnostic Tool (PEDT)
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".
Time frame: six weeks
Female Sexual Function Index (FSFI)
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.
Time frame: six weeks
Sexual Quality of Life-Female (SQOL-F)
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.
Time frame: six weeks
Plan to share: No
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Ran from Jun 2021 to primary completion in Sep 2021, 3 months.
Of 25 interventional studies with no phase under Premature Ejaculation, half reached primary completion within 9 months of starting (the median), counting those still running; a quarter within 4 and three quarters within 39. This study's 3 months is below that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jul 2023. You cannot join it, but the record below documents what was studied.
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