NCT05230875

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Apr 2022

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 2, 2021

Completed
2 months until next milestone

First Posted

Study publicly available on registry

February 9, 2022

Completed
2 months until next milestone

Study Start

First participant enrolled

April 7, 2022

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 5, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 5, 2023

Completed
Last Updated

September 28, 2022

Status Verified

September 1, 2022

Enrollment Period

1.4 years

First QC Date

December 2, 2021

Last Update Submit

September 27, 2022

Conditions

Inflammatory Bowel DiseasesCrohn DiseaseUlcerative Colitis

Keywords

Inflammatory Bowel DiseaseCrohn DiseaseUlcerative colitisQuality of lifeSexual function

Outcome Measures

Primary Outcomes (4)

  • 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 Outcomes (8)

  • 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

  • +3 more secondary outcomes

Study Arms (2)

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

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.

Interventions

self-administered questionnaireBEHAVIORAL

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 participating in the therapeutic education program

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre Hospitalier Universitaire de Bordeaux

Talence, 33400, France

RECRUITING

MeSH Terms

Conditions

Inflammatory Bowel DiseasesCrohn DiseaseColitis, Ulcerative

Condition Hierarchy (Ancestors)

GastroenteritisGastrointestinal DiseasesDigestive System DiseasesIntestinal DiseasesColitisColonic Diseases

Central Study Contacts

Pauline RIVIERE

CONTACT

0557656439pauline.riviere@chu-bordeaux.fr

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 2, 2021

First Posted

February 9, 2022

Study Start

April 7, 2022

Primary Completion

September 5, 2023

Study Completion

September 5, 2023

Last Updated

September 28, 2022

Record last verified: 2022-09

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)