Inflammatory Bowel DiseasesSexIA-CTNCT05230875
Sexual Dysfunction Among Inflammatory Bowel Disease Adults-Clinical Trial
An observational study of Inflammatory Bowel Diseases and Crohn Disease, run by University Hospital, Bordeaux at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Inflammatory Bowel Diseases, Crohn Disease, Ulcerative Colitis
- What is being tested?
- self-administered questionnaire
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 80 participants
- Where
- 1 siteFrance
- Study dates
- 7 Apr 2022to 5 Sep 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patient with Crohn's disease or Ulcerative Colitis diagnosed according to usual criteria.
Who may be able to join
- Age > 18 years
- Crohn's disease or Ulcerative Colitis diagnosed according to usual criteria
- Participation to IBD educational program
Who cannot join
- Unability to read or write French
- Patients without sexual activity for religious reasons
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Centre Hospitalier Universitaire de Bordeaux
Talence, 33400
Pauline RIVIERE, 0557656439, pauline.riviere@chu-bordeaux.fr
About this study
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.
Read the 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.
- Being tested
- self-administered questionnaire
- Keywords
- Inflammatory Bowel Disease, Crohn Disease, Ulcerative colitis, Quality of life, Sexual function
- Medical subject headings
- Inflammatory Bowel Diseases, Crohn Disease, Colitis, Ulcerative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
self-administered questionnaireBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 . Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean scores of sexual function scores using International Index of Erectile Function (IIEF) for men
Measured: before participation to educational program
Mean scores of sexual function scores using International Index of Erectile Function (IIEF) for men
Measured: from 3 to 6 months after participation to educational program.
Mean scores of sexual function scores using Female Sexual Function Index (FSFI) for women.
Measured: before participation to educational program
Mean scores of sexual function scores using Female Sexual Function Index (FSFI) for women.
Measured: from 3 to 6 months after participation to educational program.
Secondary outcomes (8)
Mean scores for quality of life (S-IBDQ)
Measured: before participation to educational program
Mean scores for quality of life (S-IBDQ)
Measured: from 3 to 6 months after participation to educational program.
Mean scores for anxiety and depression (HADS)
Measured: before participation to educational program
Mean scores for anxiety and depression (HADS)
Measured: from 3 to 6 months after participation to educational program.
Mean scores for fatigue (FSS)
Measured: before participation to educational program
Mean scores for fatigue (FSS)
Measured: from 3 to 6 months after participation to educational program.
Means score for body image (BIS).
Measured: before participation to educational program
Means score for body image (BIS).
Measured: from 3 to 6 months after participation to educational program.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2022
- Study start7 Apr 2022
- Primary completion5 Sep 2023 (estimated)
- Study completion5 Sep 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Inflammatory Bowel DiseasesStudies of the same condition, open and under way.
- More trials run by University Hospital, BordeauxThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Bordeaux
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05230875
- Sponsor's protocol ID
- CHUBX 2021/16
- Acronym
- SexIA-CT
- Status last verified
- Sep 2022
- First submitted
- 2 Dec 2021
- Last updated
- 28 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sexual Dysfunction Among Inflammatory Bowel Disease Adults-Clinical Trial
- ClinicalTrials.gov ID
- NCT05230875
- Acronym / sponsor ID
- SexIA-CT / CHUBX 2021/16
- Keywords
- Inflammatory Bowel Disease, Crohn Disease, Ulcerative colitis, Quality of life, Sexual function
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- University Hospital, BordeauxUniversity, hospital or other
- Study start
- 7 Apr 2022 (actual)
- Primary completion
- 5 Sep 2023 (estimated)
- Study completion
- 5 Sep 2023 (estimated)
- First posted
- 9 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients participating in the therapeutic education program | – | Behavioral: self-administered questionnairePatients participating in an educational program on Inflammatory Bowel Disease (IBD) including a specific discussion on intimacy and sexuality . |
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patient with Crohn's disease or Ulcerative Colitis diagnosed according to usual criteria.
Key inclusion criteria (3 listed)
- Age > 18 years
- Crohn's disease or Ulcerative Colitis diagnosed according to usual criteria
- Participation to IBD educational program
Key exclusion criteria (2 listed)
- Unability to read or write French
- Patients without sexual activity for religious reasons
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| self-administered questionnaireAll 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. | Behavioural | Patients participating in the therapeutic education program |
Primary outcome
Mean scores of sexual function scores using International Index of Erectile Function (IIEF) for men
Time frame: before participation to educational program
Mean scores of sexual function scores using International Index of Erectile Function (IIEF) for men
Time frame: from 3 to 6 months after participation to educational program.
Mean scores of sexual function scores using Female Sexual Function Index (FSFI) for women.
Time frame: before participation to educational program
Mean scores of sexual function scores using Female Sexual Function Index (FSFI) for women.
Time frame: from 3 to 6 months after participation to educational program.
8 secondary outcomes
Mean scores for quality of life (S-IBDQ)
Time frame: before participation to educational program
Mean scores for quality of life (S-IBDQ)
Time frame: from 3 to 6 months after participation to educational program.
Mean scores for anxiety and depression (HADS)
Time frame: before participation to educational program
Mean scores for anxiety and depression (HADS)
Time frame: from 3 to 6 months after participation to educational program.
Mean scores for fatigue (FSS)
Time frame: before participation to educational program
Mean scores for fatigue (FSS)
Time frame: from 3 to 6 months after participation to educational program.
Means score for body image (BIS).
Time frame: before participation to educational program
Means score for body image (BIS).
Time frame: from 3 to 6 months after participation to educational program.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Inflammatory Bowel Diseases and Crohn Disease, run by University Hospital, Bordeaux at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Pauline RIVIERE (0557656439, pauline.riviere@chu-bordeaux.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean scores of sexual function scores using International Index of Erectile Function (IIEF) for men (time frame: before participation to educational program). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2022.