Clinical trial NCT01632839: Psychometric Validation of a French Version of the PISQ-R and a New Questionnaire About Sexuality
Official title: Psychometric Validation of a French Version of the PISQ-R and a New Questionnaire About Sexuality: Tools for Evaluating Sexuality in Patients With From Urinary Incontinence or Pelvic Organ Prolapse
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Sexuality
Pelvic Organ Prolapse
Urinary Incontinence
Fecal Incontinence
Keywords: PISQ-R
new sexuality questionnaire
Lead sponsor: Centre Hospitalier Universitaire de Nīmes
Sponsor class: OTHER
First posted: 2012-07-03
Enrollment: 298
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients undergoing vaginal, abdominal or urinary incontinence surgery.

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).


Eligibility criteria: 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

Primary outcomes:
measure: PISQ-R questionnaire
timeFrame: 12 months + 1 week
Secondary outcomes:
measure: PISQ-R questionnaire
timeFrame: baseline; day 0
measure: PISQ-R questionnaire
timeFrame: 6 months
measure: PISQ-R questionnaire
timeFrame: 12 months
measure: New sexuality questionnaire
timeFrame: baseline; day 0
measure: New sexuality questionnaire
timeFrame: 6 months
measure: New sexuality questionnaire
timeFrame: 12 months
measure: New sexuality questionnaire
timeFrame: 12 months + 1 week
measure: PFDI questionnaire
timeFrame: baseline; day 0
measure: PFDI questionnaire
timeFrame: 6 months
measure: PFDI questionnaire
timeFrame: 12 months
measure: ICI-Q questionnaire
timeFrame: baseline; day 0
measure: ICI-Q questionnaire
timeFrame: 6 months
measure: ICI-Q questionnaire
timeFrame: 12 months
measure: FSFI questionnaire
timeFrame: baseline; day 0
measure: FSFI questionnaire
timeFrame: 6 months
measure: FSFI questionnaire
timeFrame: 12 months
measure: PGI-I questionnaire
timeFrame: baseline; day 0
measure: PGI-I questionnaire
timeFrame: 6 months
measure: PGI-I questionnaire
timeFrame: 12 months
Other outcomes:
Locations:
city: Clamart Cedex
country: France
facility: APHP - Hôpital Antoine Beclere
city: Clermont Ferrand
country: France
facility: CHU de Clermont Ferrand - Hôpital Estaing
city: Grande Synthe
country: France
facility: G.C.S. Flandre Maritime - site Polyclinique de Grande-Synthe
city: La Rochelle Cedex
country: France
facility: CH de la Rochelle
city: Le Kremlin Bicêtre Cedex
country: France
facility: APHP - Centre Hospitalier Universitaire de Bicêtre
city: Lille Cedex
country: France
facility: CHRU de Lille - Hôpital Jeanne de Flandre
city: Nîmes Cedex 9
country: France
facility: CHU de Nîmes - Hôpital Universitaire Carémeau
city: Paris Cedex 18
country: France
facility: APHP - Hôpital Bichat - Claude Bernard
city: Paris
country: France
facility: Groupe Hospitalier Dioconesses - Site Reuilly
city: Poitiers Cedex
country: France
facility: CHU de Poitiers
city: Pringy Cedex
country: France
facility: CH de la Région d'Annecy
city: Saint-Germain-en-Laye
country: France
facility: CH de Poissy - Saint-Germain-en-Laye
city: Strasbourg
country: France
facility: CHRU de Strasbourg - Hôpital de Hautepierre
city: Suresnes
country: France
facility: Hôpital Foch
Study officials:
affiliation: Centre Hospitalier Universitaire de Nîmes
name: Renaud de Tayrac, MD PhD
role: STUDY_DIRECTOR
affiliation: Centre Hospitalier Universitaire de Nîmes
name: Brigitte Fatton, MD
role: PRINCIPAL_INVESTIGATOR
References: