Urinary and Anorectal Functional Disorders and Their Impact on CF Adults (PerineoMucoRMO) (NCT02894619) | Clinical Trial Compass
CompletedNot Applicable
Urinary and Anorectal Functional Disorders and Their Impact on CF Adults (PerineoMucoRMO)
France180 participantsStarted 2017-01
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.