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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

180 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-01-31

Study Completion Date

2018-06-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Cystic Fibrosis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No