Clinical trial NCT02894619: Urinary and Anorectal Functional Disorders and Their Impact on CF Adults (PerineoMucoRMO)
Official title: 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cystic Fibrosis
Keywords: urinary incontinence
anal incontinence
sexuality
quality of life
Lead sponsor: Fondation Ildys
Sponsor class: OTHER
Collaborators: name: Vaincre la Mucoviscidose
name: University Hospital, Brest
First posted: 2016-09-09
Enrollment: 180
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: CF adults patients of the French North-West CF Network

Brief summary: 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Urinary Symptom Profile (USP) score
timeFrame: at time of inclusion
Secondary outcomes:
measure: Wexner Fecal Incontinence Scale
timeFrame: at time of inclusion
measure: SF-Qualiveen questionnaire
timeFrame: at time of inclusion
measure: Cystic Fibrosis Questionnaire-Revised (CFQ-R)
timeFrame: at time of inclusion
measure: International Index of Erectile Function (IIEF5) questionnaire
timeFrame: at time of inclusion
measure: Female Sexual Function Index (FSFI)
timeFrame: at time of inclusion
Other outcomes:
measure: Informations Questionnaire
timeFrame: at time of inclusion
Locations:
city: Angers
country: France
facility: CF Center - University Hospital
city: Nantes
country: France
facility: CF Center - Hôpital Laennec
city: Rennes
country: France
facility: CF Center - Hopital Pontchaillou
city: Roscoff
country: France
facility: CF Center - Fondation Ildys Site de Perharidy
city: St Pierre
country: France
facility: CF Center - Groupe Hospitalier Sud Réunion
city: Vannes
country: France
facility: CF Center - CH Bretagne Atlantique
Study officials:
affiliation: Fondation Ildys
name: Sophie Ramel, MD
role: STUDY_DIRECTOR
affiliation: Fondation Ildys
name: Katelyne Hubeaux, MD
role: STUDY_DIRECTOR
References: