Validation of a French Version of the PISQ-R
|ClinicalTrials.gov Identifier: NCT01548976|
Recruitment Status : Completed
First Posted : March 8, 2012
Last Update Posted : March 26, 2015
|Condition or disease|
|Pelvic Organ Prolapse Urinary Incontinence Fecal Incontinence|
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.
|Study Type :||Observational|
|Actual Enrollment :||25 participants|
|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|
|Study Start Date :||April 2012|
|Actual Primary Completion Date :||May 2012|
|Actual Study Completion Date :||May 2012|
The study population
Patients suffering from pelvic organ prolapse and/or urinary incontinence and/or fecal incontinence. See inclusion/exclusion criteria.
- Patient comprehension [ Time Frame: Baseline (Day 0; transversal study) ]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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01548976
|CHU de Nîmes - Hôpital Universitaire Carémeau|
|Nîmes Cedex 09, Gard, France, 30029|
|Principal Investigator:||Brigitte Fatton, MD||Centre Hospitalier Universitaire de Nîmes|