Sexual Dysfunction Among Inflammatory Bowel Disease Adults-Clinical Trial (SexIA-CT)

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.

Study Overview

• Status: Recruiting
• Conditions: Inflammatory Bowel Diseases; Crohn Disease; Ulcerative Colitis
• Intervention / Treatment: Behavioral: self-administered questionnaire

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 Type: Observational
• Enrollment (Anticipated): 80

Contacts and Locations

• Study Contact: Name: Pauline RIVIERE; Phone Number: 0557656439; Email: pauline.riviere@chu-bordeaux.fr

Study Locations

• France
  • Talence, France, 33400
    • Recruiting
    • Centre Hospitalier Universitaire de Bordeaux
    • Contact: Pauline RIVIERE; Phone Number: 0557656439; Email: pauline.riviere@chu-bordeaux.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patient with Crohn's disease or Ulcerative Colitis diagnosed according to usual criteria.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patients participating in the therapeutic education program; Patients participating in an educational program on Inflammatory Bowel Disease (IBD) including a specific discussion on intimacy and sexuality .	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.
Patients control (not participating in the therapeutic education program); A control group (at the rate of two controls for one case) will be made up of IBD patients routinely followed in the gastroenterology department.Those patients will not participate in the therapeutic education program.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Mean scores of sexual function scores using International Index of Erectile Function (IIEF) for men	before participation to educational program
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.	before 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

Outcome Measure	Time Frame
Mean scores for quality of life (S-IBDQ)	before participation to educational program
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)	before 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)	before 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).	before participation to educational program
Means score for body image (BIS).	from 3 to 6 months after participation to educational program.

Collaborators and Investigators

• Sponsor: University Hospital, Bordeaux

Study record dates

Study Major Dates

• Study Start (Actual): April 7, 2022
• Primary Completion (Anticipated): September 5, 2023
• Study Completion (Anticipated): September 5, 2023

Study Registration Dates

• First Submitted: December 2, 2021
• First Submitted That Met QC Criteria: January 27, 2022
• First Posted (Actual): February 9, 2022

Study Record Updates

• Last Update Posted (Actual): September 28, 2022
• Last Update Submitted That Met QC Criteria: September 27, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Keywords: Quality of life; Inflammatory Bowel Disease; Ulcerative colitis; Crohn Disease; Sexual function
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Gastrointestinal Diseases; Gastroenteritis; Colonic Diseases; Ulcer; Inflammatory Bowel Diseases; Crohn Disease; Intestinal Diseases; Colitis; Colitis, Ulcerative
• Other Study ID Numbers: CHUBX 2021/16

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No