Skip to main content
Clinical Trials/NCT01548976
NCT01548976
Completed
N/A

Validation of a French Version of the PISQ-R: a Tool for Evaluating the Sexuality of Patients With Urinary Incontinence or Pelvic Organ Prolapse

Centre Hospitalier Universitaire de Nīmes1 site in 1 country25 target enrollmentApril 2012

Overview

Phase
N/A
Intervention
Not specified
Conditions
Pelvic Organ Prolapse
Sponsor
Centre Hospitalier Universitaire de Nīmes
Enrollment
25
Locations
1
Primary Endpoint
Patient comprehension
Status
Completed
Last Updated
11 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
April 2012
End Date
May 2012
Last Updated
11 years ago
Study Type
Observational
Sex
Female

Investigators

Sponsor
Centre Hospitalier Universitaire de Nīmes
Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

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.

Study Sites (1)

Loading locations...

Similar Trials