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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Nīmes
ClinicalTrials.gov Identifier:
NCT01632839
First received: June 29, 2012
Last updated: April 5, 2016
Last verified: April 2016
  Purpose
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).

Condition
Sexuality
Pelvic Organ Prolapse
Urinary Incontinence
Fecal Incontinence

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by NLM:


Further study details as provided by Centre Hospitalier Universitaire de Nīmes:

Primary Outcome Measures:
  • PISQ-R questionnaire [ Time Frame: 12 months + 1 week ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • PISQ-R questionnaire [ Time Frame: baseline; day 0 ] [ Designated as safety issue: No ]
  • PISQ-R questionnaire [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • PISQ-R questionnaire [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • New sexuality questionnaire [ Time Frame: baseline; day 0 ] [ Designated as safety issue: No ]
  • New sexuality questionnaire [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • New sexuality questionnaire [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • New sexuality questionnaire [ Time Frame: 12 months + 1 week ] [ Designated as safety issue: No ]
  • PFDI questionnaire [ Time Frame: baseline; day 0 ] [ Designated as safety issue: No ]
  • PFDI questionnaire [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • PFDI questionnaire [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • ICI-Q questionnaire [ Time Frame: baseline; day 0 ] [ Designated as safety issue: No ]
  • ICI-Q questionnaire [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • ICI-Q questionnaire [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • FSFI questionnaire [ Time Frame: baseline; day 0 ] [ Designated as safety issue: No ]
  • FSFI questionnaire [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • FSFI questionnaire [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • PGI-I questionnaire [ Time Frame: baseline; day 0 ] [ Designated as safety issue: No ]
  • PGI-I questionnaire [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • PGI-I questionnaire [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Enrollment: 298
Study Start Date: January 2013
Estimated Study Completion Date: March 2017
Estimated Primary Completion Date: March 2017 (Final data collection date for primary outcome measure)
Groups/Cohorts
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.

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients undergoing vaginal, abdominal or urinary incontinence surgery.
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01632839

Locations
France
APHP - Hôpital Antoine Beclere
Clamart Cedex, France, 92141
CHU de Clermont Ferrand - Hôpital Estaing
Clermont Ferrand, France, 63003
G.C.S. Flandre Maritime - site Polyclinique de Grande-Synthe
Grande Synthe, France, 59760
CH de la Rochelle
La Rochelle Cedex, France, 17019
APHP - Centre Hospitalier Universitaire de Bicêtre
Le Kremlin Bicêtre Cedex, France, 94275
CHRU de Lille - Hôpital Jeanne de Flandre
Lille Cedex, France, 59037
CHU de Nîmes - Hôpital Universitaire Carémeau
Nîmes Cedex 9, France, 30029
APHP - Hôpital Bichat - Claude Bernard
Paris Cedex 18, France, 75877
Groupe Hospitalier Dioconesses - Site Reuilly
Paris, France, 75012
CHU de Poitiers
Poitiers Cedex, France, 86021
CH de la Région d'Annecy
Pringy Cedex, France, 74374
CH de Poissy - Saint-Germain-en-Laye
Saint-Germain-en-Laye, France, 78100
CHRU de Strasbourg - Hôpital de Hautepierre
Strasbourg, France, 67098
Hôpital Foch
Suresnes, France, 92151
Sponsors and Collaborators
Centre Hospitalier Universitaire de Nīmes
Investigators
Study Director: Renaud de Tayrac, MD PhD Centre Hospitalier Universitaire de Nîmes
Principal Investigator: Brigitte Fatton, MD Centre Hospitalier Universitaire de Nîmes
  More Information

Responsible Party: Centre Hospitalier Universitaire de Nīmes
ClinicalTrials.gov Identifier: NCT01632839     History of Changes
Other Study ID Numbers: LOCAL/2011/BF-03  2012-A00303-40 
Study First Received: June 29, 2012
Last Updated: April 5, 2016
Health Authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé
France: Committee for the Protection of Personnes

Keywords provided by Centre Hospitalier Universitaire de Nīmes:
PISQ-R
new sexuality questionnaire

Additional relevant MeSH terms:
Urinary Incontinence
Enuresis
Prolapse
Pelvic Organ Prolapse
Fecal Incontinence
Urination Disorders
Urologic Diseases
Lower Urinary Tract Symptoms
Urological Manifestations
Signs and Symptoms
Behavioral Symptoms
Elimination Disorders
Mental Disorders
Pathological Conditions, Anatomical
Rectal Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on August 30, 2016