Cystic Fibrosis Clinical Trial
— PerineoMucoOfficial 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
Verified date | May 2021 |
Source | Fondation Ildys |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
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 |
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 |
Lead Sponsor | Collaborator |
---|---|
Fondation Ildys | University Hospital, Brest, Vaincre la Mucoviscidose |
France,
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 |
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