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

Completed

• Conditions: Cystic Fibrosis

• Registration Number: NCT02894619
• Lead Sponsor: Fondation Ildys

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.

Study Timeline

• Study First Submitted: 2016-08-30
• Study First Submitted QC: 2016-09-08
• Study First Posted: 2016-09-09
• Study Start: 2017-01
• Primary Completion: 2018-02
• Study Completion: 2018-06
• Status Verified: 2021-05
• Last Update Submitted: 2021-05-06
• Last Update Posted: 2021-05-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 180

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Urinary Symptom Profile (USP) score	at time of inclusion	Assesses lower urinary tract symptoms (stress urinary incontinence, overactive bladder syndrome and dysuria)

Secondary Outcome Measures

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

Trial Locations

Locations (6)

CF Center - Hopital Pontchaillou; 🇫🇷 Rennes, France

CF Center - Hôpital Laennec; 🇫🇷 Nantes, France

CF Center - Fondation Ildys Site de Perharidy; 🇫🇷 Roscoff, France

CF Center - Groupe Hospitalier Sud Réunion; 🇫🇷 St Pierre, France

CF Center - CH Bretagne Atlantique; 🇫🇷 Vannes, France

CF Center - University Hospital; 🇫🇷 Angers, France