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Completed

NCT Number: NCT02894619

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

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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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Urinary Symptom Profile (USP) score

    Time frame: at time of inclusion

    Assesses lower urinary tract symptoms (stress urinary incontinence, overactive bladder syndrome and dysuria)

Secondary outcomes

  1. Wexner Fecal Incontinence Scale

    Time frame: at time of inclusion

    Assesses anal incontinence and its impact on quality of life

  2. SF-Qualiveen questionnaire

    Time frame: at time of inclusion

    Assesses impact of urinary disorders on quality of life

  3. Cystic Fibrosis Questionnaire-Revised (CFQ-R)

    Time frame: at time of inclusion

    Assesses quality of live related to cystic fibrosis

  4. International Index of Erectile Function (IIEF5) questionnaire

    Time frame: at time of inclusion

    Assesses male sexual dysfunction

  5. Female Sexual Function Index (FSFI)

    Time frame: at time of inclusion

    Assesses female sexual dysfunction

Other outcomes

  1. Informations Questionnaire

    Time frame: at time of inclusion

    identification and prevalence of risk factors; impact degree of disorders on care, social and love life, sexuality

Sponsors and collaborators

Lead sponsor

Fondation Ildys

Other

Collaborators

  • University Hospital, Brest
  • Vaincre la Mucoviscidose

Registry information

Official study 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

Acronym: PerineoMuco

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Sep 9, 2016
Registry last updated
May 10, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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