NCT01548989

Brief Summary

The main objective of this study is to perform the linguistic validation of a new french questionnaire in a population of sexually active (or not) patients who have undergone surgery (or not) for stress urinary incontinence or genital prolapse.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
25

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Apr 2012

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

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

February 29, 2012

Completed
8 days until next milestone

First Posted

Study publicly available on registry

March 8, 2012

Completed
24 days until next milestone

Study Start

First participant enrolled

April 1, 2012

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2012

Completed
Last Updated

March 26, 2015

Status Verified

March 1, 2015

Enrollment Period

3 months

First QC Date

February 29, 2012

Last Update Submit

March 25, 2015

Conditions

Pelvic Organ ProlapseUrinary IncontinenceFecal Incontinence

Keywords

linguistic validation of a new questionnaire

Outcome Measures

Primary Outcomes (1)

  • Patient comprehension

    These tests assess patient understanding of the original formulation and patient understanding of the various terms used: a list of proposed rewording suggested by patients is made.

    Baseline (Day 0; transversal study)

Study Arms (1)

The study population

Patients suffering from pelvic organ prolapse and/or urinary incontinence and/or fecal incontinence. See inclusion/exclusion criteria.

Eligibility Criteria

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

Patients suffering from pelvic organ prolapse and/or urinary incontinence and/or fecal incontinence.

You may qualify if:

  • The patient is able to read and understand French
  • The patient must be insured or beneficiary of a health insurance plan
  • Patients suffering from pelvic organ prolapse and/or urinary incontinence and/or fecal incontinence.

You may not qualify if:

  • Patient is pregnant
  • The patient is under judicial protection, under tutorship or curatorship
  • The patient does not understand French

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU de Nîmes - Hôpital Universitaire Carémeau

Nîmes, Gard, 30029, France

Location

MeSH Terms

Conditions

Pelvic Organ ProlapseUrinary IncontinenceFecal Incontinence

Condition Hierarchy (Ancestors)

ProlapsePathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsUrination DisordersUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesLower Urinary Tract SymptomsUrological ManifestationsSigns and SymptomsRectal DiseasesIntestinal DiseasesGastrointestinal DiseasesDigestive System Diseases

Study Officials

  • Brigitte Fatton, MD

    Centre Hospitalier Universitaire de Nîmes

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 29, 2012

First Posted

March 8, 2012

Study Start

April 1, 2012

Primary Completion

July 1, 2012

Study Completion

July 1, 2012

Last Updated

March 26, 2015

Record last verified: 2015-03

Locations

FR(1)