Clinical trial NCT05230875: Sexual Dysfunction Among Inflammatory Bowel Disease Adults-Clinical Trial
Official title: Sexual Dysfunction Among Inflammatory Bowel Disease Adults-Clinical Trial
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Inflammatory Bowel Diseases
Crohn Disease
Ulcerative Colitis
Keywords: Inflammatory Bowel Disease
Crohn Disease
Ulcerative colitis
Quality of life
Sexual function
Lead sponsor: University Hospital, Bordeaux
Sponsor class: OTHER
First posted: 2022-02-09
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patient with Crohn's disease or Ulcerative Colitis diagnosed according to usual criteria.

Brief summary: Patients with Inflammatory Bowel Disease (IBD) have higher rates of sexual dysfunction than the general population. We offer an educational program on IBD including a specific discussion on intimacy and sexuality for IBD patients. Our objective is to investigate the benefit of this intervention on sexual function in patients with IBD.

Detailed description: Patients with Inflammatory Bowel Disease (IBD) have higher rates of sexual dysfunction than healthy controls. No interventional study has addressed this matter so far. The aim of our study is to investigative the benefit of a psycho-educational intervention on sexual function in patients with IBD, by comparing patients participating to an educational program including a specific discussion on intimacy and sexuality to patients followed in usual care.

Eligibility criteria: Inclusion Criteria:

* Age \> 18 years
* Crohn's disease or Ulcerative Colitis diagnosed according to usual criteria
* Participation to IBD educational program

Exclusion Criteria:

* Unability to read or write French
* Patients without sexual activity for religious reasons

Primary outcomes:
measure: Mean scores of sexual function scores using International Index of Erectile Function (IIEF) for men
timeFrame: before participation to educational program
measure: Mean scores of sexual function scores using International Index of Erectile Function (IIEF) for men
timeFrame: from 3 to 6 months after participation to educational program.
measure: Mean scores of sexual function scores using Female Sexual Function Index (FSFI) for women.
timeFrame: before participation to educational program
measure: Mean scores of sexual function scores using Female Sexual Function Index (FSFI) for women.
timeFrame: from 3 to 6 months after participation to educational program.
Secondary outcomes:
measure: Mean scores for quality of life (S-IBDQ)
timeFrame: before participation to educational program
measure: Mean scores for quality of life (S-IBDQ)
timeFrame: from 3 to 6 months after participation to educational program.
measure: Mean scores for anxiety and depression (HADS)
timeFrame: before participation to educational program
measure: Mean scores for anxiety and depression (HADS)
timeFrame: from 3 to 6 months after participation to educational program.
measure: Mean scores for fatigue (FSS)
timeFrame: before participation to educational program
measure: Mean scores for fatigue (FSS)
timeFrame: from 3 to 6 months after participation to educational program.
measure: Means score for body image (BIS).
timeFrame: before participation to educational program
measure: Means score for body image (BIS).
timeFrame: from 3 to 6 months after participation to educational program.
Other outcomes:
Locations:
city: Talence
country: France
facility: Centre Hospitalier Universitaire de Bordeaux
Study officials:
References: