NCT04225962

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
211

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2019

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

November 19, 2019

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 9, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 13, 2020

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 18, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 18, 2021

Completed
Last Updated

June 8, 2022

Status Verified

June 1, 2022

Enrollment Period

1.5 years

First QC Date

January 9, 2020

Last Update Submit

June 7, 2022

Conditions

Mucoviscidosis

Keywords

Cystic fibrosisWomenPrivate lifeSexual disordersQuality of sex life

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

Women with cystic fibrosis

Women with cystic fibrosis

Other: Intimate quality of life questionnaire

Interventions

Intimate quality of life questionnaireOTHER

Preparation of an intimate quality of life questionnaire

Women with cystic fibrosis

Eligibility Criteria

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

Adult patients with cystic fibrosis

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hôpital Lyon Sud - CRCM adultes, médecine interne

Pierre-Bénite, France

Location

MeSH Terms

Conditions

Cystic FibrosisSexual Dysfunction, Physiological

Condition Hierarchy (Ancestors)

Pancreatic DiseasesDigestive System DiseasesLung DiseasesRespiratory Tract DiseasesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesInfant, Newborn, DiseasesGenital DiseasesUrogenital Diseases

Study Officials

  • Françoise SIMONNET-BISSON

    Hospices Civils de Lyon

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

January 9, 2020

First Posted

January 13, 2020

Study Start

November 19, 2019

Primary Completion

May 18, 2021

Study Completion

May 18, 2021

Last Updated

June 8, 2022

Record last verified: 2022-06

Locations

FR(1)