Sexual Dysfunction Among Inflammatory Bowel Disease Adults-Clinical Trial

Recruiting

• Conditions: Ulcerative Colitis; Inflammatory Bowel Diseases; Crohn Disease
• Interventions: Behavioral: self-administered questionnaire

• Registration Number: NCT05230875
• Lead Sponsor: University Hospital, Bordeaux

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.

Study Timeline

• Study First Submitted: 2021-12-02
• Study First Submitted QC: 2022-01-27
• Study First Posted: 2022-02-09
• Study Start: 2022-04-07
• Status Verified: 2022-09
• Last Update Submitted: 2022-09-27
• Last Update Posted: 2022-09-28
• Primary Completion: 2023-09-05
• Study Completion: 2023-09-05

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 80

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients participating in the therapeutic education program	self-administered questionnaire	Patients participating in an educational program on Inflammatory Bowel Disease (IBD) including a specific discussion on intimacy and sexuality .

Primary Outcome Measures

Name	Time	Method
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.
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 Outcome Measures

Name	Time	Method
Mean scores for quality of life (S-IBDQ)	from 3 to 6 months after participation to educational program.
Mean scores for anxiety and depression (HADS)	from 3 to 6 months after participation to educational program.
Mean scores for fatigue (FSS)	from 3 to 6 months after participation to educational program.
Means score for body image (BIS).	from 3 to 6 months after participation to educational program.

Trial Locations

Locations (1)

Centre Hospitalier Universitaire de Bordeaux; 🇫🇷 Talence, France