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

Cystic Fibrosis Clinical Trial

— PerineoMuco  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02894619
• Other study ID #: ILDYS-ISRNI-2015003
• Secondary ID: RC20160501608
• Status: Completed
• Start date: January 2017
• Est. completion date: June 2018

Study information

• Verified date: May 2021
• Source: Fondation Ildys
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 180
• Est. completion date: June 2018
• Est. primary completion date: February 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cystic Fibrosis

Locations

Country	Name	City	State
France	CF Center - University Hospital	Angers
France	CF Center - Hôpital Laennec	Nantes
France	CF Center - Hopital Pontchaillou	Rennes
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

Sponsors (3)

Lead Sponsor	Collaborator
Fondation Ildys	University Hospital, Brest, Vaincre la Mucoviscidose

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Informations Questionnaire	identification and prevalence of risk factors; impact degree of disorders on care, social and love life, sexuality	at time of inclusion
Primary	Urinary Symptom Profile (USP) score	Assesses lower urinary tract symptoms (stress urinary incontinence, overactive bladder syndrome and dysuria)	at time of inclusion
Secondary	Wexner Fecal Incontinence Scale	Assesses anal incontinence and its impact on quality of life	at time of inclusion
Secondary	SF-Qualiveen questionnaire	Assesses impact of urinary disorders on quality of life	at time of inclusion
Secondary	Cystic Fibrosis Questionnaire-Revised (CFQ-R)	Assesses quality of live related to cystic fibrosis	at time of inclusion
Secondary	International Index of Erectile Function (IIEF5) questionnaire	Assesses male sexual dysfunction	at time of inclusion
Secondary	Female Sexual Function Index (FSFI)	Assesses female sexual dysfunction	at time of inclusion

External Links

•   Informations aboit project