Urinary and Anorectal Functional Disorders and Their Impact on CF Adults (PerineoMucoRMO) (PerineoMuco)

May 6, 2021 updated by: Fondation Ildys

Assessment of the Prevalence and Severity of Urinary and Ano-rectal Functional Disorders and Their Impact on Quality of Life and Sexuality on CF Adults of the North-West CF Network

This observational study evaluates prevalence of functional perinea disorders (stress urinary incontinence, overactive bladder syndrome, dysuria, anal incontinence) on CF adults patients of the North-West CF Network. Its aims are to measure the severity of urinary and anorectal symptoms ; assess their impact on patients' quality of life, sexuality, care and social life and relationships ; identify the medical and demographic factors associated with the severity of urinary and anorectal disorders and their impact and determine the relationship between the severity of these disorders, various repercussions, and risk factors.

Study Overview

Status

Completed

Conditions

Detailed Description

Urine and/or anal leakage are more frequent and troublesome for CF patients: leaks occur during efforts or laugh like in other people, but also when coughing or sneezing, which are amplified during periods of exacerbation and with the degradation of the pulmonary condition. In addition, fear of leakage can disrupt medical care: discomfort during physiotherapy, pulmonary function test. Urinary and anorectal functional disorders are therefore not only a factor degrading the quality of life but also a risk factor for worsening bronchial obstruction, patients limiting their cough and / or their care to avoid episodes of leakage. Given the lack literature data, investigators wanted to explore these areas.

Validated and specific questionnaires will be self and anonymously administered to adult patients (n=175). The time requested to fill the forms is estimated to 1H. Questionnaires about sexual health are optional.

Prospects considered, depending on the results, are:

  • Extension to the adolescent population (14 and over);
  • National extension;
  • Systematic proposal of a screening and an appropriate management of pelvic floor functional disorders, depending on influent characteristics (age, gender ...): multidisciplinary working group to develop guidelines and specific tools for professional training and / or patient education;
  • Implementation of a comparative study of interventions.

Study Type

Observational

Enrollment (Actual)

180

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
      • Angers, France, 49933
        • CF Center - University Hospital
      • Nantes, France, 44093
        • CF Center - Hôpital Laennec
      • Rennes, France, 35033
        • CF Center - Hopital Pontchaillou
      • Roscoff, France, 29684
        • CF Center - Fondation Ildys Site de Perharidy
      • St Pierre, France, 97448
        • CF Center - Groupe Hospitalier Sud Réunion
      • Vannes, France, 56017
        • CF Center - CH Bretagne Atlantique

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

CF adults patients of the French North-West CF Network

Description

Inclusion Criteria:

  • Men and women 18 years and over
  • Cystic fibrosis confirmed by sweat test or genetic
  • Followed in an adult or mixed CF Center of the French North-West CF Network
  • Not transplanted and not entered on the waiting list for transplantation
  • In a stable condition for at least 4 weeks
  • Able to understand and respect the protocol and its requirements
  • Who signed the consent prior to any other procedure protocol

Exclusion Criteria:

  • Major patients under guardianship / curatorship
  • Patients seen in emergency situation
  • Pregnant patients
  • Dialysis patients
  • Patients with urolithiasis
  • Patients with severe exacerbation at the time of inclusion
  • Patients on intravenous antibiotics within 4 weeks prior to inclusion
  • Patient with an urinary tract infection (evaluation by dipstick at the time of inclusion

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Urinary Symptom Profile (USP) score
Time Frame: at time of inclusion
Assesses lower urinary tract symptoms (stress urinary incontinence, overactive bladder syndrome and dysuria)
at time of inclusion

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Wexner Fecal Incontinence Scale
Time Frame: at time of inclusion
Assesses anal incontinence and its impact on quality of life
at time of inclusion
SF-Qualiveen questionnaire
Time Frame: at time of inclusion
Assesses impact of urinary disorders on quality of life
at time of inclusion
Cystic Fibrosis Questionnaire-Revised (CFQ-R)
Time Frame: at time of inclusion
Assesses quality of live related to cystic fibrosis
at time of inclusion
International Index of Erectile Function (IIEF5) questionnaire
Time Frame: at time of inclusion
Assesses male sexual dysfunction
at time of inclusion
Female Sexual Function Index (FSFI)
Time Frame: at time of inclusion
Assesses female sexual dysfunction
at time of inclusion

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Informations Questionnaire
Time Frame: at time of inclusion
identification and prevalence of risk factors; impact degree of disorders on care, social and love life, sexuality
at time of inclusion

Collaborators and Investigators

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

Sponsor

Fondation Ildys

Collaborators

University Hospital, Brest
Vaincre la Mucoviscidose

Investigators

  • Study Director: Sophie Ramel, MD, Fondation Ildys
  • Study Director: Katelyne Hubeaux, MD, Fondation Ildys

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

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)

January 1, 2017

Primary Completion (Actual)

February 1, 2018

Study Completion (Actual)

June 1, 2018

Study Registration Dates

First Submitted

August 30, 2016

First Submitted That Met QC Criteria

September 8, 2016

First Posted (Estimate)

September 9, 2016

Study Record Updates

Last Update Posted (Actual)

May 10, 2021

Last Update Submitted That Met QC Criteria

May 6, 2021

Last Verified

May 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ILDYS-ISRNI-2015003
  • RC20160501608 (Other Grant/Funding Number: Vaincre La Mucoviscidose (CF French Association))

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

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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