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

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

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).

Study Overview

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

• Study Type: Observational
• Enrollment (Actual): 298

Contacts and Locations

Study Locations

• France
  • Clamart Cedex, France, 92141
    • APHP - Hôpital Antoine Béclère
  • Clermont Ferrand, France, 63003
    • CHU de Clermont Ferrand - Hopital Estaing
  • Grande Synthe, France, 59760
    • G.C.S. Flandre Maritime - site Polyclinique de Grande-Synthe
  • La Rochelle Cedex, France, 17019
    • CH de la Rochelle
  • Le Kremlin Bicêtre Cedex, France, 94275
    • APHP - Centre Hospitalier Universitaire de Bicêtre
  • Lille Cedex, France, 59037
    • CHRU de Lille - Hôpital Jeanne de Flandre
  • Nîmes Cedex 9, France, 30029
    • CHU de Nimes - Hopital Universitaire Caremeau
  • Paris, France, 75012
    • Groupe Hospitalier Dioconesses - Site Reuilly
  • Paris Cedex 18, France, 75877
    • APHP - Hopital Bichat - Claude Bernard
  • Poitiers Cedex, France, 86021
    • CHU de Poitiers
  • Pringy Cedex, France, 74374
    • CH de la Region d'Annecy
  • Saint-Germain-en-Laye, France, 78100
    • CH de Poissy - Saint-Germain-en-Laye
  • Strasbourg, France, 67098
    • CHRU de Strasbourg - Hopital de Hautepierre
  • Suresnes, France, 92151
    • Hopital Foch

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

Patients undergoing vaginal, abdominal or urinary incontinence surgery.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

8

Cohorts and Interventions

Group / Cohort
Vaginal surgery +prothesis +sexuality; The 50 patients included in this group will have undergone vaginal surgery for pelvic organ prolapse with placement of a prothesis; these patients are sexually active.
Vaginal surgery +prothesis -sexuality; The 25 patients included in this group will have undergone vaginal surgery for pelvic organ prolapse with placement of a prothesis; these patients are NOT sexually active.
Vaginal surgery -prothesis + sexuality; The 50 patients included in this group will have undergone vaginal surgery for pelvic organ prolapse WITHOUT placement of a prothesis; these patients are sexually active.
Vaginal surgery -prothesis -sexuality; The 25 patients included in this group will have undergone vaginal surgery for pelvic organ prolapse WITHOUT placement of a prothesis; these patients are NOT sexually active.
Abdominal surgery +sexuality; The 50 patients included in this group will have undergone abdominal surgery for pelvic organ prolapse; these patients are sexually active.
Abdominal surgery -sexuality; The 25 patients included in this group will have undergone abdominal surgery for pelvic organ prolapse; these patients are NOT sexually active.
Urinary incontinence surgery + sexuality; The 50 patients included in this group will have surgery for urinary incontinence; these patients are sexually active.
Urinary incontinence surgery - sexuality; The 25 patients included in this group will have surgery for urinary incontinence; these patients are NOT sexually active.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
PISQ-R questionnaire	12 months + 1 week

Secondary Outcome Measures

Outcome Measure	Time Frame
PISQ-R questionnaire	baseline; day 0
PISQ-R questionnaire	6 months
PISQ-R questionnaire	12 months
New sexuality questionnaire	baseline; day 0
New sexuality questionnaire	6 months
New sexuality questionnaire	12 months
New sexuality questionnaire	12 months + 1 week
PFDI questionnaire	baseline; day 0
PFDI questionnaire	6 months
PFDI questionnaire	12 months
ICI-Q questionnaire	baseline; day 0
ICI-Q questionnaire	6 months
ICI-Q questionnaire	12 months
FSFI questionnaire	baseline; day 0
FSFI questionnaire	6 months
FSFI questionnaire	12 months
PGI-I questionnaire	baseline; day 0
PGI-I questionnaire	6 months
PGI-I questionnaire	12 months

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Nīmes
• Investigators: Study Director: Renaud de Tayrac, MD PhD, Centre Hospitalier Universitaire de Nimes; Principal Investigator: Brigitte Fatton, MD, Centre Hospitalier Universitaire de Nimes

Study record dates

Study Major Dates

• Study Start (Actual): January 18, 2013
• Primary Completion (Actual): April 21, 2017
• Study Completion (Actual): April 21, 2017

Study Registration Dates

• First Submitted: June 29, 2012
• First Submitted That Met QC Criteria: June 29, 2012
• First Posted (Estimate): July 3, 2012

Study Record Updates

• Last Update Posted (Actual): March 26, 2018
• Last Update Submitted That Met QC Criteria: March 23, 2018
• Last Verified: July 1, 2017

More Information

Terms related to this study

• Keywords: PISQ-R; new sexuality questionnaire
• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Digestive System Diseases; Urologic Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Gastrointestinal Diseases; Urination Disorders; Intestinal Diseases; Pathological Conditions, Anatomical; Rectal Diseases; Elimination Disorders; Urinary Incontinence; Prolapse; Pelvic Organ Prolapse; Enuresis; Fecal Incontinence
• Other Study ID Numbers: LOCAL/2011/BF-03; 2012-A00303-40 (Other Identifier: RCB number)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No