Validation of a French Version of the PISQ-R

Completed

• Conditions: Fecal Incontinence; Pelvic Organ Prolapse; Urinary Incontinence

• Registration Number: NCT01548976
• Lead Sponsor: Centre Hospitalier Universitaire de Nīmes

Brief Summary

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

Detailed Description

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 Timeline

• Study First Submitted: 2012-02-28
• Study First Submitted QC: 2012-03-06
• Study First Posted: 2012-03-08
• Study Start: 2012-04
• Primary Completion: 2012-05
• Study Completion: 2012-05
• Status Verified: 2015-03
• Last Update Submitted: 2015-03-25
• Last Update Posted: 2015-03-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 25

Inclusion Criteria

• 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.

Exclusion Criteria

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Patient comprehension	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.

Trial Locations

Locations (1)

CHU de Nîmes - Hôpital Universitaire Carémeau; 🇫🇷 Nîmes Cedex 09, Gard, France