Intimacy of Women With Cystic Fibrosis

Mucoviscidosis Clinical Trial

— IFAM  

Official title:

Intimacy of Women With Cystic Fibrosis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04225962
• Other study ID #: 69HCL19_0422
• Secondary ID: 2019-A01988-49
• Status: Completed
• Start date: November 19, 2019
• Est. completion date: May 18, 2021

Study information

• Verified date: June 2022
• Source: Hospices Civils de Lyon
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The intimate life of patients with cystic fibrosis has not been the subject of specific research, it is even left behind in favor of respiratory, digestive or endocrinological dysfunctions endangering these patients. After 16 years of practice, it is significant that this subject is problematic, painful but difficult to tackle; No doubt just as much on the side of caregivers: this question has never found its way into team exchanges, it seems to be evaded doubtless difficult or too intimate to welcome. These disorders arise from the effects of the disease on the health of the mucous epithelial tissues also located in the genital area. These difficulties are more closely approached by the difficulties of procreation; PMA allows them to get around them, nevertheless making it possible to be a parent, with the residual frustration of a satisfactory sex life: a deaf "addition", adding to many care constraints.

It is therefore in terms of sexual health and quality of sexual life that it is desirable to shed light on this aspect of cystic fibrosis in women.

Bibliographic research confirms this approach: this subject is not explored, the rare publications concern the vulnerability of the cervix or the difficulty on both sides of tackling this subject.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 211
• Est. completion date: May 18, 2021
• Est. primary completion date: May 18, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Major women with cystic fibrosis

• Tracked in the various CRCMs in France,

• Having or having had sexual intercourse,

• Having previously been informed of the aims and confidentiality of this research and not having opposed their participation.

Exclusion Criteria:

• Major women with cystic fibrosis whose state of health (acute episode of their disease or worsening phase) does not lend itself to such a collection

• Adult women with cystic fibrosis who are unable to receive the information and make a non-objection

Related Conditions & MeSH terms

• Cystic Fibrosis
• Fibrosis
• Mucoviscidosis

Intervention

Other:
• Intimate quality of life questionnaire
Preparation of an intimate quality of life questionnaire

Locations

Country	Name	City	State
France	Hôpital Lyon Sud - CRCM adultes, médecine interne	Pierre-Bénite

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Assessment of specific intimate disorders of patients with cystic fibrosis	Passing a questionnaire to assess patients' intimate quality of life.; The responses to binary qualitative variables will be described by proportions. The responses to the 5-modality ordinal qualitative variables will be described by the median and the range (minimum and maximum). Continuous quantitative variables will be described by the mean and its standard deviation.	12 months