Validation of a French Version of the PISQ-R

Urinary Incontinence Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01548976
• Other study ID #: LOCAL/2011/BF-01
• Secondary ID: 2012-A00133-40
• Status: Completed
• Phase: N/A
• First received: February 28, 2012
• Last updated: March 25, 2015
• Start date: April 2012
• Est. completion date: May 2012

Study information

• Verified date: March 2015
• Source: Centre Hospitalier Universitaire de Nimes
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)France: Committee for the Protection of Personnes
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: May 2012
• Est. primary completion date: May 2012
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Observational Model: Case-Only, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Fecal Incontinence
• Pelvic Organ Prolapse
• Prolapse
• Urinary Incontinence

Locations

Country	Name	City	State
France	CHU de Nîmes - Hôpital Universitaire Carémeau	Nîmes Cedex 09	Gard

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Nimes

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	No