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

NCT05707429 | Completed

• 1 other identifier: assiut IBD
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Sexual Function Disturbances; Inflammatory Bowel Diseases

Outcome Measures

Primary Outcomes (1)

• inactive IBD &sexual function of both males

  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

  3 months

Secondary Outcomes (1)

• Mean scores for quality of life among inactive IBD patients

  3 months

Study Arms (2)

Healthy control group

will include patient's relatives or volunteers, who accept to participate in the study through invitation or posters which send or spread it to all staff hospitals about importance of the study.

Other: The Arabic version of The International Index of Erectile Function (IIEF-5); Other: The Sexual Quality of Life Questionnaire Male/Female (SQoL M/F); Other: Assessment of depression and anxiety; Other: The Fatigue assessment scale (16); Other: • Quality of life assessment; Other: The Female Sexual Function Index (FSFI)

IBD patients inactive group

IBD patients group: they will be recruited from outpatient clinic and inpatient with CD or UC at the Gastroenterology department at Alrajhi hospital. CD patients will be assessed by the Crohn's Disease Activity Index a score of less than 150 corresponds to relative disease quiescence (remission); 150 to 219, mildly active disease; 220 to 450, moderately active disease; and greater than 450, severe disease (9).

Other: The Arabic version of The International Index of Erectile Function (IIEF-5); Other: The Sexual Quality of Life Questionnaire Male/Female (SQoL M/F); Other: Assessment of depression and anxiety; Other: The Fatigue assessment scale (16); Other: • Quality of life assessment; Other: The Female Sexual Function Index (FSFI)

Interventions

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 .

Healthy control group; IBD patients inactive group

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.

Healthy control group; IBD patients inactive group

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.

Healthy control group; IBD patients inactive group

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.

Healthy control group; IBD patients inactive group

• 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.

Healthy control group; IBD patients inactive group

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.

Healthy control group; IBD patients inactive group

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

Will include 2 groups: IBD patients inactive group and healthy control group. IBD patients group: they will be recruited from outpatient clinic and inpatient with CD or UC at the Gastroenterology department at Alrajhi hospital. Healthy control group: will include patient's relatives or volunteers, who accept to participate in the study through invitation or posters which send or spread it to all staff hospitals about importance of the study. All participants will subject to

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

Assiut University

Asyut, Egypt

Location

MeSH Terms

Conditions

Sexual Dysfunctions, Psychological; Inflammatory Bowel Diseases

Condition Hierarchy (Ancestors)

Mental Disorders; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Study Officials

• ahmed mahmoud abd ella hassan, MD

  Assiut university ,andrology departement

  STUDY CHAIR

• mostafa Mohammed Hashem, MD

  Assiut University

  STUDY DIRECTOR

• ahmed abdelfadeel maghrapy, MD

  Assiut University

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Target Duration: 3 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: assistant lecturer

Study Record Dates

• First Submitted: January 14, 2023
• First Posted: February 1, 2023
• Study Start: February 1, 2023
• Primary Completion: August 1, 2023
• Study Completion: February 1, 2024
• Last Updated: March 19, 2024

Record last verified: 2024-03

Locations

EG (1)