Clinical trial NCT05707429: Sexual Function and Quality of Life Among Patients Suffering From Inflammatory Bowel Disease(Inactive Stage)
Official title: Sexual Function and Quality of Life Among Patients Suffering From Inflammatory Bowel Disease During Remmsion
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Sexual Function Disturbances
Inflammatory Bowel Diseases
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2023-02-01
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
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

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

Eligibility criteria: 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.

Primary outcomes:
measure: inactive IBD &sexual function of both males
timeFrame: 3 months
Secondary outcomes:
measure: Mean scores for quality of life among inactive IBD patients
timeFrame: 3 months
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Assiut University
Study officials:
affiliation: Assiut university ,andrology departement
name: ahmed mahmoud abd ella hassan, MD
role: STUDY_CHAIR
affiliation: Assiut University
name: mostafa Mohammed Hashem, MD
role: STUDY_DIRECTOR
affiliation: Assiut University
name: ahmed abdelfadeel maghrapy, MD
role: STUDY_DIRECTOR
References: