Intimacy of Women With Cystic Fibrosis (IFAM)

June 7, 2022 updated by: Hospices Civils de Lyon

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

211

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Pierre-Bénite, France
        • Hôpital Lyon Sud - CRCM adultes, médecine interne

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Adult patients with cystic fibrosis

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Women with cystic fibrosis
Other: Intimate quality of life questionnaire
Preparation of an intimate quality of life questionnaire

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospices Civils de Lyon

Investigators

  • Principal Investigator: Françoise SIMONNET-BISSON, Hospices Civils de Lyon

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 19, 2019

Primary Completion (Actual)

May 18, 2021

Study Completion (Actual)

May 18, 2021

Study Registration Dates

First Submitted

January 9, 2020

First Submitted That Met QC Criteria

January 10, 2020

First Posted (Actual)

January 13, 2020

Study Record Updates

Last Update Posted (Actual)

June 8, 2022

Last Update Submitted That Met QC Criteria

June 7, 2022

Last Verified

June 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 69HCL19_0422
  • 2019-A01988-49 (Other Identifier: ID-RCB)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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