Sexual Dysfunction Among Inflammatory Bowel Disease Adults-Clinical Trial

Ulcerative Colitis Clinical Trial

— SexIA-CT  

Official title:

Sexual Dysfunction Among Inflammatory Bowel Disease Adults-Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05230875
• Other study ID #: CHUBX 2021/16
• Status: Recruiting
• Start date: April 7, 2022
• Est. completion date: September 5, 2023

Study information

• Verified date: September 2022
• Source: University Hospital, Bordeaux
• Contact: Pauline RIVIERE
• Phone: 0557656439
• Email: pauline.riviere[@]chu-bordeaux.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: September 5, 2023
• Est. primary completion date: September 5, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Colitis
• Colitis, Ulcerative
• Crohn Disease
• Inflammatory Bowel Diseases
• Intestinal Diseases
• Ulcer
• Ulcerative Colitis

Intervention

Behavioral:
• self-administered questionnaire
All patients participating in the therapeutic education program will complete a self-administered questionnaire before participation in educational program. A new identical self-questionnaire will be distributed to patients 3 to 6 months after their participation in the therapeutic education program.

Locations

Country	Name	City	State
France	Centre Hospitalier Universitaire de Bordeaux	Talence

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Bordeaux

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean scores of sexual function scores using International Index of Erectile Function (IIEF) for men		before participation to educational program
Primary	Mean scores of sexual function scores using International Index of Erectile Function (IIEF) for men		from 3 to 6 months after participation to educational program.
Primary	Mean scores of sexual function scores using Female Sexual Function Index (FSFI) for women.		before participation to educational program
Primary	Mean scores of sexual function scores using Female Sexual Function Index (FSFI) for women.		from 3 to 6 months after participation to educational program.
Secondary	Mean scores for quality of life (S-IBDQ)		before participation to educational program
Secondary	Mean scores for quality of life (S-IBDQ)		from 3 to 6 months after participation to educational program.
Secondary	Mean scores for anxiety and depression (HADS)		before participation to educational program
Secondary	Mean scores for anxiety and depression (HADS)		from 3 to 6 months after participation to educational program.
Secondary	Mean scores for fatigue (FSS)		before participation to educational program
Secondary	Mean scores for fatigue (FSS)		from 3 to 6 months after participation to educational program.
Secondary	Means score for body image (BIS).		before participation to educational program
Secondary	Means score for body image (BIS).		from 3 to 6 months after participation to educational program.