Intimacy of Women With Cystic Fibrosis (IFAM)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04225962|
Recruitment Status : Recruiting
First Posted : January 13, 2020
Last Update Posted : January 13, 2020
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.
|Condition or disease||Intervention/treatment|
|Mucoviscidosis||Other: Intimate quality of life questionnaire|
|Study Type :||Observational|
|Estimated Enrollment :||200 participants|
|Official Title:||Intimacy of Women With Cystic Fibrosis|
|Actual Study Start Date :||November 19, 2019|
|Estimated Primary Completion Date :||November 2020|
|Estimated Study Completion Date :||November 2020|
Women with cystic fibrosis
Women with cystic fibrosis
Other: Intimate quality of life questionnaire
Preparation of an intimate quality of life questionnaire
- Assessment of specific intimate disorders of patients with cystic fibrosis [ Time Frame: 12 months ]
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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04225962
|Contact: Françoise SIMONNET-BISSON||0478861558 ext +firstname.lastname@example.org|
|Hôpital Lyon Sud||Recruiting|
|Contact: Françoise SIMONNET-BISSON 0478861558 ext +33 email@example.com|
|Principal Investigator: Françoise SIMONNET-BISSON|
|Principal Investigator:||Françoise SIMONNET-BISSON||Hospices Civils de Lyon|