Cystic FibrosisPerineoMucoNCT02894619
Urinary and Anorectal Functional Disorders and Their Impact on CF Adults (PerineoMucoRMO)
An observational study of Cystic Fibrosis, run by Fondation Ildys at 6 sites in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cystic Fibrosis
- How many people
- 180 participants
- Where
- 6 sitesFrance
- Study dates
- Jan 2017to Jun 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: CF adults patients of the French North-West CF Network
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
France6 sites
CF Center - University Hospital
Angers, 49933
CF Center - Hôpital Laennec
Nantes, 44093
CF Center - Hopital Pontchaillou
Rennes, 35033
CF Center - Fondation Ildys Site de Perharidy
Roscoff, 29684
CF Center - Groupe Hospitalier Sud Réunion
Saint-Pierre-des-Corps, 97448
CF Center - CH Bretagne Atlantique
Vannes, 56017
About this study
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
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.
Read the 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.
- Conditions
- Cystic Fibrosis
- Keywords
- urinary incontinence, anal incontinence, sexuality, quality of life
- Medical subject headings
- Cystic Fibrosis, Urinary Incontinence, Encopresis, Sexuality
What is being measured
The primary outcome is the main question the study is designed to answer.
Urinary Symptom Profile (USP) score
Assesses lower urinary tract symptoms (stress urinary incontinence, overactive bladder syndrome and dysuria)
Measured: at time of inclusion
Secondary outcomes (5)
Wexner Fecal Incontinence Scale
Assesses anal incontinence and its impact on quality of life
Measured: at time of inclusion
SF-Qualiveen questionnaire
Assesses impact of urinary disorders on quality of life
Measured: at time of inclusion
Cystic Fibrosis Questionnaire-Revised (CFQ-R)
Assesses quality of live related to cystic fibrosis
Measured: at time of inclusion
International Index of Erectile Function (IIEF5) questionnaire
Assesses male sexual dysfunction
Measured: at time of inclusion
Female Sexual Function Index (FSFI)
Assesses female sexual dysfunction
Measured: at time of inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2016 (estimated)
- Study startJan 2017
- Primary completionFeb 2018
- Study completionJun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cystic FibrosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 180 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fondation Ildys
- Sponsor type
- University, hospital or other
- Collaborators
- Vaincre la Mucoviscidose, University Hospital, Brest
- Responsible party
- Sponsor
- Investigators
- Sophie Ramel, MD, Study director, Fondation IldysKatelyne Hubeaux, MD, Study director, Fondation Ildys
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02894619
- Sponsor's protocol ID
- ILDYS-ISRNI-2015003
- Other IDs
- RC20160501608
- Acronym
- PerineoMuco
- Status last verified
- May 2021
- First submitted
- 30 Aug 2016
- Last updated
- 10 May 2021
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02894619
- Acronym / sponsor ID
- PerineoMuco / ILDYS-ISRNI-2015003
- Conditions
- Cystic Fibrosis
- Keywords
- urinary incontinence, anal incontinence, sexuality, quality of life
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 180 participants (actual)
- Lead sponsor
- Fondation IldysUniversity, hospital or other
- Collaborators
- Vaincre la Mucoviscidose, University Hospital, Brest
- Study start
- Jan 2017 (actual)
- Primary completion
- Feb 2018 (actual)
- Study completion
- Jun 2018 (actual)
- First posted
- 9 Sep 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- CF adults patients of the French North-West CF Network
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (8 listed)
- Major patients under guardianship / curatorship
- Patients seen in emergency situation
- Pregnant patients
- Dialysis patients
- Patients with urolithiasis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Urinary Symptom Profile (USP) score
Time frame: at time of inclusion
Assesses lower urinary tract symptoms (stress urinary incontinence, overactive bladder syndrome and dysuria)
5 secondary outcomes
Wexner Fecal Incontinence Scale
Time frame: at time of inclusion
SF-Qualiveen questionnaire
Time frame: at time of inclusion
Cystic Fibrosis Questionnaire-Revised (CFQ-R)
Time frame: at time of inclusion
International Index of Erectile Function (IIEF5) questionnaire
Time frame: at time of inclusion
Female Sexual Function Index (FSFI)
Time frame: at time of inclusion
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2021.
- Individual participant dataSharing planned: No
Related trials for Cystic Fibrosis
RecruitingPhase 2
A Study of 24 to 52 Weeks Treatment to Evaluate The Efficacy And Safety of Galvokimig in Adult Study Participants With Non-Cystic Fibrosis Bronchiectasis
Non-cystic Fibrosis Bronchiectasis
Active, not recruitingObservational study
CFTR Modulator Effects on Bone and Muscle in Adults With Cystic Fibrosis
Cystic Fibrosis, Bone Loss
RecruitingObservational study
Natural History of Bronchiectasis
Bronchiectasis, Cystic Fibrosis
RecruitingObservational study
Role of Genetic Factors in the Development of Lung Disease
Cystic Fibrosis, Pulmonary Fibrosis
RecruitingPhase 2
Early Study on Tamoxifen Safety/Tolerability in Cystic Fibrosis Patients Unable to Use CFTR Modulators.
Cystic Fibrosis - Complete
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sophie Ramel, MD study director
Fondation Ildys
Katelyne Hubeaux, MD study director
Fondation Ildys
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cystic Fibrosis, run by Fondation Ildys at 6 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Urinary Symptom Profile (USP) score (time frame: at time of inclusion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 May 2021.