NCT02894619

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
180

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2017

Geographic Reach
1 country

6 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 30, 2016

Completed
10 days until next milestone

First Posted

Study publicly available on registry

September 9, 2016

Completed
4 months until next milestone

Study Start

First participant enrolled

January 1, 2017

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2018

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2018

Completed
Last Updated

May 10, 2021

Status Verified

May 1, 2021

Enrollment Period

1.1 years

First QC Date

August 30, 2016

Last Update Submit

May 6, 2021

Conditions

Cystic Fibrosis

Keywords

urinary incontinenceanal incontinencesexualityquality of life

Outcome Measures

Primary Outcomes (1)

  • Urinary Symptom Profile (USP) score

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

    at time of inclusion

Secondary Outcomes (5)

  • Wexner Fecal Incontinence Scale

    at time of inclusion

  • SF-Qualiveen questionnaire

    at time of inclusion

  • Cystic Fibrosis Questionnaire-Revised (CFQ-R)

    at time of inclusion

  • International Index of Erectile Function (IIEF5) questionnaire

    at time of inclusion

  • Female Sexual Function Index (FSFI)

    at time of inclusion

Other Outcomes (1)

  • Informations Questionnaire

    at time of inclusion

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

CF adults patients of the French North-West CF Network

You may qualify if:

  • 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

You may not qualify if:

  • Major patients under guardianship / curatorship
  • Patients seen in emergency situation
  • Pregnant patients
  • Dialysis patients
  • Patients with urolithiasis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

CF Center - University Hospital

Angers, 49933, France

Location

CF Center - Hôpital Laennec

Nantes, 44093, France

Location

CF Center - Hopital Pontchaillou

Rennes, 35033, France

Location

CF Center - Fondation Ildys Site de Perharidy

Roscoff, 29684, France

Location

CF Center - Groupe Hospitalier Sud Réunion

Saint-Pierre-des-Corps, 97448, France

Location

CF Center - CH Bretagne Atlantique

Vannes, 56017, France

Location

Related Links

MeSH Terms

Conditions

Cystic FibrosisUrinary IncontinenceEncopresisSexuality

Condition Hierarchy (Ancestors)

Pancreatic DiseasesDigestive System DiseasesLung DiseasesRespiratory Tract DiseasesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesInfant, Newborn, DiseasesUrination DisordersUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesLower Urinary Tract SymptomsUrological ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsSigns and Symptoms, DigestiveBehavioral SymptomsBehaviorElimination DisordersMental DisordersSexual Behavior

Study Officials

  • Sophie Ramel, MD

    Fondation Ildys

    STUDY DIRECTOR

  • Katelyne Hubeaux, MD

    Fondation Ildys

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 30, 2016

First Posted

September 9, 2016

Study Start

January 1, 2017

Primary Completion

February 1, 2018

Study Completion

June 1, 2018

Last Updated

May 10, 2021

Record last verified: 2021-05

Data Sharing

IPD Sharing
Will not share

Locations

FR(6)