Validation of a French Version of the PISQ-R
Pelvic Organ Prolapse
|Study Design:||Observational Model: Case-Only
Time Perspective: Cross-Sectional
|Official Title:||Validation of a French Version of the PISQ-R: a Tool for Evaluating the Sexuality of Patients With Urinary Incontinence or Pelvic Organ Prolapse|
- Patient comprehension [ Time Frame: Baseline (Day 0; transversal study) ] [ Designated as safety issue: No ]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.
|Study Start Date:||April 2012|
|Study Completion Date:||May 2012|
|Primary Completion Date:||May 2012 (Final data collection date for primary outcome measure)|
The study population
Patients suffering from pelvic organ prolapse and/or urinary incontinence and/or fecal incontinence. See inclusion/exclusion criteria.
Step 1: Establish a French translation of the original questionnaire (English> French.
Step 2: Perform a first set of comprehension tests with a panel of 15 patients.
Step 3: Establish a revised questionnaire.
Step 4: Perform a second series of comprehension tests with a panel of 10 other patients.
Step 5: Determine the final questionnaire.
Step 6: Perform a back-translation (French> English.
Step 7: Send the final version of the questionnaire and the questionnaire back-translated to the specific committee of the IUGA for final approval.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01548976
|CHU de Nîmes - Hôpital Universitaire Carémeau|
|Nîmes Cedex 09, Gard, France, 30029|
|Principal Investigator:||Brigitte Fatton, MD||Centre Hospitalier Universitaire de Nîmes|