Psychometric Validation of a French Version of the PISQ-R and a New Questionnaire About Sexuality

Completed

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

• Registration Number: NCT01632839
• Lead Sponsor: Centre Hospitalier Universitaire de Nīmes

Brief Summary

The primary objective of this study is the psychometric validation of two questionnaires (PISQ-R and a new questionnaire on sexuality) as compared to a non specific questionnaire on female sexual function (FSFI).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-06-29
• Study First Submitted QC: 2012-06-29
• Study First Posted: 2012-07-03
• Study Start: 2013-01-18
• Primary Completion: 2017-04-21
• Study Completion: 2017-04-21
• Status Verified: 2017-07
• Last Update Submitted: 2018-03-23
• Last Update Posted: 2018-03-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 298

Inclusion Criteria

• Patient is not pregnant
• Patient can read and understand French
• The patient must have given her informed and signed consent
• The patient must be insured or beneficiary of a health insurance plan
• The patient has genital prolapse and/or urinary incontinence and/or anal incontinence, and have undergone surgery

Exclusion Criteria

• The patient is under judicial protection
• The patient does not understand french
• Patient has vulvodynia
• Patient has painful bladder syndrome
• The patient has had chronic pelvic pain for longer than 6 months

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
PISQ-R questionnaire	12 months + 1 week

Secondary Outcome Measures

Name	Time	Method
PGI-I questionnaire	12 months
FSFI questionnaire	12 months
PISQ-R questionnaire	12 months
New sexuality questionnaire	12 months + 1 week
PFDI questionnaire	12 months
ICI-Q questionnaire	12 months

Trial Locations

Locations (14)

APHP - Hôpital Bichat - Claude Bernard; 🇫🇷 Paris Cedex 18, France

CHU de Poitiers; 🇫🇷 Poitiers Cedex, France

CH de la Région d'Annecy; 🇫🇷 Pringy Cedex, France

CH de Poissy - Saint-Germain-en-Laye; 🇫🇷 Saint-Germain-en-Laye, France

CHRU de Strasbourg - Hôpital de Hautepierre; 🇫🇷 Strasbourg, France

Hôpital Foch; 🇫🇷 Suresnes, France

APHP - Hôpital Antoine Beclere; 🇫🇷 Clamart Cedex, France

G.C.S. Flandre Maritime - site Polyclinique de Grande-Synthe; 🇫🇷 Grande Synthe, France

APHP - Centre Hospitalier Universitaire de Bicêtre; 🇫🇷 Le Kremlin Bicêtre Cedex, France

CHU de Clermont Ferrand - Hôpital Estaing; 🇫🇷 Clermont Ferrand, France

CH de la Rochelle; 🇫🇷 La Rochelle Cedex, France

CHRU de Lille - Hôpital Jeanne de Flandre; 🇫🇷 Lille Cedex, France

CHU de Nîmes - Hôpital Universitaire Carémeau; 🇫🇷 Nîmes Cedex 9, France

Groupe Hospitalier Dioconesses - Site Reuilly; 🇫🇷 Paris, France