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CompletedNCT04841395Updated Apr 12, 2021

Chronotype and Premature Ejaculation

An observational study in Premature Ejaculation, sponsored by Bursa Yüksek İhtisas Education and Research Hospital. Completed at 1 site in Turkey. Open to male participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-04-12.

Sponsored by Bursa Yüksek İhtisas Education and Research Hospital · Observational

Study type
Observational
Model
Case-control
Time perspective
Cross-sectional
Enrollment
217
Ages
18 Years to 50 Years
Sex
Male
01

Study summary

Chronotype (or circadian preference) has previously been shown to be associated with sexual attitudes and behaviors and is an important factor affecting sexual satisfaction. The fact that some neurobiological variables, which are thought to have a role in ejaculation physiology, are also effective in the processes of sleep and the regulation of circadian rhythm, and evidence supporting the relationship between circadian preferences and sexual desire and sexual behavior; suggests that ejaculation disorders may be related to circadian preference. The aim of the present study was to investigate the relationship between intravaginal ejaculatory latency time (IELT), severity of disease and chronotype in lifelong PE.

Read the detailed description

After being informed about the study, all patients who gave written informed consent were questioned and diagnosed as lifelong PE according to the definition of International Society of sexual medicine (ISSM) by an experienced urologist. Since erctile dysfunction (ED) may accompany PE, the presence of ED symptoms was evaluated by the International Index of Erectile Function (IIEF-5), and those with IIEF-5 score \<22 were excluded from the study. Age- and sex-matched control cases without lifelong PE were selected randomly among cases attending the hospital for a checkup procedure. A total of 114 patients with PE and 103 control subjects with similar sociodemographic characteristics were included in the study. A detailed medical and sexual history was taken, which included self-estimated intravaginal ejaculatory latency time (IELT), by an experienced sexual therapist. Moreover, Arabic Index of Premature Ejaculation (AIPE), Pittsburgh Sleep Quality Index (PSQI) and Morningness-Eveningness Questionnaire (MEQ) were administered to all participants.

02

Conditions studied

  • Premature Ejaculation
03

Who can participate

Ages eligible
18 Years to 50 Years
Sexes eligible
Male
Accepts healthy volunteers
Yes
Sampling method
Probability sample

Study population

Males who presented at the outpatient clinic of Urology with the self-reported complaint of lifelong premature ejaculation

Inclusion criteria

  • male between the ages of 18-50 years,
  • being sexually active, and in a stable relationship with a single partner for the last 6 months
  • meeting diagnostic criteria of Premature ejaculation according to ISSM.

Exclusion criteria

Exclusion Criteria:

  • having a history of neurological and/or psychiatric disorders, any malignancies, sexual dysfunction other than PE, chronic systemic disease, or if they were taking alpha-blockers, phosphodiesterase type-5 inhibitors, 5-alpha reductase inhibitors, anticholinergics, antipsychotics, or antidepressants.
  • presence of obesity (body mass index (BMI)> 30)
  • presence of Erectile Dysfunction (IIEF-5 score \<22)
04

Study design

Observational model
Case-control
Time perspective
Cross-sectional
Enrollment
217 participants (actual)
Patient registry
No

Groups and cohorts

  • PE

    Premature ejaculation group

    Diagnostic Test: Intravaginal ejaculatory latency time (IELT), Arabic Index of Premature Ejaculation (AIPE), Morningness-Eveningness Questionnaire (MEQ)

  • CG

    Control group (Healthy subjects)

    Diagnostic Test: Intravaginal ejaculatory latency time (IELT), Arabic Index of Premature Ejaculation (AIPE), Morningness-Eveningness Questionnaire (MEQ)

Interventions

  • Diagnostic testIntravaginal ejaculatory latency time (IELT), Arabic Index of Premature Ejaculation (AIPE), Morningness-Eveningness Questionnaire (MEQ)

    Self-estimated intravaginal ejaculatory latency time IELT is defined as the time between the onset of vaginal intromission and the onset of intravaginal ejaculation. In the present research, self-estimated IELT duration was obtained as a result of interviews with the participants. Moreover, Arabic Index of Premature Ejaculation (AIPE), International Index of Erectile Function (IIEF-5), Pittsburgh Sleep Quality Index (PSQI) and Morningness-Eveningness Questionnaire (MEQ) were administered to all participants.

05

What researchers measure

Primary outcomes

  1. MEQ scores

    MEQ is a measurement tool developed to measure the morning and evening sleep cycle associated with circadian rhythm (Horne \& Östberg, 1976). It consists of 19 self-reported likert-type items and has a rating range from 16 to 86. Higher scores in the MEQ refer to morningness chronotype, and lower scores refer to eveningness chronotype. In the Turkish adaptation study of MEQ, three different categories of circadian rhythm were defined as; 59-86 points "morningness type", 42-58 points "intermediate type", 16-41 points "eveningness type"

    Time frame: Baseline

06

Study locations

1 site
  • Bursa Yuksek Ihtisas Training and Research Hospital
    Bursa, 16500, Turkey
07

References and documents

Publications

  • Jankowski KS, Diaz-Morales JF, Randler C. Chronotype, gender, and time for sex. Chronobiol Int. 2014 Oct;31(8):911-6. doi: 10.3109/07420528.2014.925470. Epub 2014 Jun 13. PubMed 24927370 ↗
  • Jocz P, Stolarski M, Jankowski KS. Similarity in Chronotype and Preferred Time for Sex and Its Role in Relationship Quality and Sexual Satisfaction. Front Psychol. 2018 Apr 4;9:443. doi: 10.3389/fpsyg.2018.00443. eCollection 2018. PubMed 29670559 ↗
  • Kasaeian A, Weidenauer C, Hautzinger M, Randler C. Reproductive Success, Relationship Orientation, and Sexual Behavior in Heterosexuals: Relationship With Chronotype, Sleep, and Sex. Evol Psychol. 2019 Jul-Sep;17(3):1474704919859760. doi: 10.1177/1474704919859760. PubMed 31272215 ↗

Individual participant data

Plan to share: No

08

Registry details

Key details

Study ID
NCT04841395
Lead sponsor
Bursa Yüksek İhtisas Education and Research Hospital
Responsible party
Sinay Önen (Associate Professor, Bursa Yüksek İhtisas Education and Research Hospital) — Principal investigator
First posted
Apr 12, 2021
Start date
Jun 1, 2019
Primary completion
Aug 30, 2019
Completion
Dec 30, 2019
Last update
Apr 12, 2021

Study contacts

Efe Önen, M.D.
principal investigator · Bursa Yuksek Ihtisas Training and Research Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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