Validation of a French Version of the PISQ-R

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.

Completed

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Key information

Conditions

Pelvic Organ Prolapse Digestive System Diseases Fecal Incontinence Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Gastrointestinal Diseases Intestinal Diseases Lower Urinary Tract Symptoms Male Urogenital Diseases Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Prolapse Rectal Diseases Signs and Symptoms Urinary Incontinence Urination Disorders Urogenital Diseases Urologic Diseases Urological Manifestations

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

CHU de Nîmes - Hôpital Universitaire Carémeau

Nîmes, Gard, 30029, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Nīmes

Other

Registry information

Official study 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

Important dates

Study start: 2012
Primary completion: 2012
Study completion: 2012
First posted: Mar 8, 2012
Registry last updated: Mar 26, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed