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Completed

NCT Number: NCT05707429

Sexual Function and Quality of Life Among Patients Suffering From Inflammatory Bowel Disease(Inactive Stage)

Sexual dysfunction [SD] is a significant health burden characterized by a disturbance in sexual desire and psychophysiological changes in the sexual response cycle, resulting in marked distress and interpersonal difficulty (4). As known, both SD and depression are interrelated, so, depression may be an important determinant of sexual functioning in patients with IBD(5).

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Key information

Conditions

Sexual Function Disturbances Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Inflammatory Bowel Diseases Intestinal Diseases Mental Disorders Sexual Dysfunctions, Psychological

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Assiut University

Asyut, Egypt

About this study

Inflammatory Bowel Diseases (IBD), Crohn's disease (CD) and ulcerative colitis (UC), are characterized by a chronically relapsing course (1).

IBD is likely to have a substantial impact on body image, intimacy and sexuality, Because of symptoms like abdominal pain, fatigue, bloating, gas, and diarrhea (2).

Complications may include perianal disease, fistulae and abscesses. Surgery is frequently necessary, sometimes including the placement of a stoma or pouch. Furthermore, mood disorders, mainly depression, are reported to be common in IBD (3) .

Sexual dysfunction [SD] is a significant health burden characterized by a disturbance in sexual desire and psychophysiological changes in the sexual response cycle, resulting in marked distress and interpersonal difficulty (4). As known, both SD and depression are interrelated, so, depression may be an important determinant of sexual functioning in patients with IBD(5).

For female IBD patients, SD mainly manifests as decreased sexual desire, orgasm, and sexual arousal disorder, while for men, the most common symptom is erectile dysfunction (ED) (6).

Friedman and Knowles et al. reported that the prevalence of SD in male and female IBD patients ranged from 44% to 53.9% and 40% to 66%, respectively (7).

However, SD in IBD patients still has not attracted widespread attention, and relevant research studies are scarce.

The current study aims to assess sexual functions in patients with inactive IBD and its associated factors with sociodemographic and clinical characteristics.

assessment sexual function among inflammatory bowel disease during disease inactivity

it will evaluate the predictors and impact of SD on quality of life among those patients

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 18-50 years old.
  • Both sexes
  • A stable sexual partner for ≥3 months
  • ability to fill in and understand the questionnaire
  • sign informed consent and participate voluntarily. For control group: An age-matched control group of healthy men and women, in the same region will also be invited to participate. The controls will eligible if they are 18-50 years of age, have a stable heterosexual relationship for at least 3 months and do not have bowel like IBD or irritable bowel syndrome or psychiatric problems.

Exclusion criteria

  • Those who couldn't understand or fill out the questionnaire themselves and/or those with mental disorders
  • Diagnosis of SD before an IBD diagnosis
  • SD compounded by other diseases: cardiovascular and cerebrovascular diseases, lung diseases, liver and kidney dysfunction, diabetic neuropathy, other psychiatric disorders (e.g. depression), and neoplastic diseases, etc.
  • History or current use of psychotropic drugs or medications have sexual side effects.

Treatment and study plan

The Arabic version of The International Index of Erectile Function (IIEF-5)

Other

The Arabic version of The International Index of Erectile Function A self-administered questionnaire that assesses 5 dimensions of sexual function over the most recent 4 weeks. It consists of five questions, including vaginal penetration, maintenance of erection, completion of intercourse, sexual satisfaction, and self-confidence of the patient's sexual arousal and maintenance of an erection. A total score of < 22 is defined as ED .

The Sexual Quality of Life Questionnaire Male/Female (SQoL M/F)

Other

was developed by Symonds et al.,(14) which assesses subjects' feelings toward their sexuality (ranging from 0% to 100%, with higher scores indicating higher SQoL). The SQoL M/F was developed as a condition-specific QoL questionnaire to test the relationship between sexual symptoms and other aspects of general health and sexual QoL.

Assessment of depression and anxiety

Other

Arabic version of Hamilton depression and anxiety rating scale (15): used to measure the severity of anxiety and depressive symptoms, and is widely used in both clinical and research settings.

The Fatigue assessment scale (16)

Other

It is a 10-item self-report scale evaluating symptoms of fatigue. The FAS treats fatigue as a unidimensional construct and does not separate its measurement into different factors. However, in order to ensure that the scale evaluates all aspects of fatigue, it measures both physical and mental symptoms. The total score ranges from 10 to 50, with a higher score indicating more severe fatigue.

• Quality of life assessment

Other

Health related quality of life (HRQoL measure): using the Short Inflammatory Bowel Disease Questionnaire (SIBDQ) (17), which assesses physical, social, and emotional domains of IBD patients' lives (scores range from 10-70, with higher scores indicating better HRQoL) The SIBDQ reflects relevant clinical changes in both CD and UC.

The Female Sexual Function Index (FSFI)

Other

The FSFI includes such parameters as desire, arousal, lubrication, orgasm, satisfaction, and pain. The optimal cutoff score of the FSFI is 26.55, which means that a score at or below this value is defined as female SD.

Primary outcomes

  1. inactive IBD &sexual function of both males

    Time frame: 3 months

    using questionnaire IIEF-5 score It consists of five questions, including vaginal penetration, maintenance of erection, completion of intercourse, sexual satisfaction, and self-confidence of the patient's sexual arousal and maintenance of an erection

    • A total score of < 22 is defined as ED . females using FSFI score.
    • The optimal cutoff score of the FSFI is 26.55, which means that a score at or below this value is defined as female SD

Secondary outcomes

  1. Mean scores for quality of life among inactive IBD patients

    Time frame: 3 months

    (using health related quality of life questionnaire)

    The SQoL M/F was developed as a condition-specific QoL questionnaire to test the relationship between sexual symptoms and other aspects of general health and sexual QoL

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Official study title

Sexual Function and Quality of Life Among Patients Suffering From Inflammatory Bowel Disease During Remmsion

Important dates

Study start
2023
Primary completion
2023
Study completion
2024
First posted
Feb 1, 2023
Registry last updated
Mar 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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