Sexual Dysfunction Among Inflammatory Bowel Disease Adults-Clinical Trial

Study Overview
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Brief Summary
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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
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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.

Official Title
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Sexual Dysfunction Among Inflammatory Bowel Disease Adults-Clinical Trial

Conditions
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Inflammatory Bowel Diseases, Crohn Disease, Ulcerative Colitis

Intervention / Treatment
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* Behavioral: self-administered questionnaire


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients participating in the therapeutic education program<br>Patients participating in an educational program on Inflammatory Bowel Disease (IBD) including a specific discussion on intimacy and sexuality . | Behavioral: self-administered questionnaire<br>* 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.<br>|
| Patients control (not participating in the therapeutic education program)<br>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?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 | Measure Description | 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. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Inflammatory Bowel Disease, Crohn Disease, Ulcerative colitis, Quality of life, Sexual function