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

Completed
Conditions
Sexual Function Disturbances
Inflammatory Bowel Diseases
Interventions
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)
Registration Number
NCT05707429
Lead Sponsor
Assiut University
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).

Detailed Description

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

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
80
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.

Study & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Arm && Interventions
GroupInterventionDescription
Healthy control groupThe Fatigue assessment scale (16)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.
Healthy control groupThe Arabic version of The International Index of Erectile Function (IIEF-5)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.
Healthy control group• Quality of life assessmentwill 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.
Healthy control groupThe Sexual Quality of Life Questionnaire Male/Female (SQoL M/F)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.
Healthy control groupAssessment of depression and anxietywill 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.
IBD patients inactive groupThe Arabic version of The International Index of Erectile Function (IIEF-5)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).
IBD patients inactive groupThe Female Sexual Function Index (FSFI)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).
Healthy control groupThe Female Sexual Function Index (FSFI)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.
IBD patients inactive groupThe Sexual Quality of Life Questionnaire Male/Female (SQoL M/F)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).
IBD patients inactive groupAssessment of depression and anxietyIBD 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).
IBD patients inactive groupThe Fatigue assessment scale (16)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).
IBD patients inactive group• Quality of life assessmentIBD 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).
Primary Outcome Measures
NameTimeMethod
inactive IBD &sexual function of both males3 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 Outcome Measures
NameTimeMethod
Mean scores for quality of life among inactive IBD patients3 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

Trial Locations

Locations (1)

Assiut University

🇪🇬

Assiut, Egypt

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