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

Sponsor

Fondation Ildys (Other)

Overall Status

Completed

CT.gov ID

NCT02894619

Collaborator

Vaincre la Mucoviscidose (Other), University Hospital, Brest (Other)

180

Enrollment

Locations

Actual Duration (Months)

Patients Per Site

1.8

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Cystic Fibrosis

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 Design

Study Type:

Observational

Actual Enrollment :

180 participants

Observational Model:

Cohort

Time Perspective:

Prospective

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

Actual Study Start Date :

Jan 1, 2017

Actual Primary Completion Date :

Feb 1, 2018

Actual Study Completion Date :

Jun 1, 2018

Outcome Measures

Primary Outcome Measures

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

Wexner Fecal Incontinence Scale [at time of inclusion]
Assesses anal incontinence and its impact on quality of life
SF-Qualiveen questionnaire [at time of inclusion]
Assesses impact of urinary disorders on quality of life
Cystic Fibrosis Questionnaire-Revised (CFQ-R) [at time of inclusion]
Assesses quality of live related to cystic fibrosis
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

Other Outcome Measures

Informations Questionnaire [at time of inclusion]
identification and prevalence of risk factors; impact degree of disorders on care, social and love life, sexuality

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	Country	Postal Code
1	CF Center - University Hospital	Angers	France	49933
2	CF Center - Hôpital Laennec	Nantes	France	44093
3	CF Center - Hopital Pontchaillou	Rennes	France	35033
4	CF Center - Fondation Ildys Site de Perharidy	Roscoff	France	29684
5	CF Center - Groupe Hospitalier Sud Réunion	St Pierre	France	97448
6	CF Center - CH Bretagne Atlantique	Vannes	France	56017