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

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2014 by Centre Hospitalier Universitaire de Nīmes
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Nīmes
ClinicalTrials.gov Identifier:
NCT01632839
First received: June 29, 2012
Last updated: November 3, 2014
Last verified: November 2014
  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 ]

Estimated Enrollment: 300
Study Start Date: January 2013
Estimated Study Completion Date: September 2016
Estimated Primary Completion Date: September 2016 (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
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

Contacts
Contact: Brigitte Fatton, MD +33.(0)4.66.68.32.16 brigitte.fatton@chu-nimes.fr
Contact: Carey Suehs, PhD +33.(0)4.66.68.67.88 carey.suehs@chu-nimes.fr

Locations
France
APHP - Hôpital Antoine Beclere Recruiting
Clamart Cedex, France, 92141
Sub-Investigator: Xavier Deffieux, MD         
CHU de Clermont Ferrand - Hôpital Estaing Recruiting
Clermont Ferrand, France, 63003
Sub-Investigator: Bernard Jacquetin, MD PhD         
G.C.S. Flandre Maritime - site Polyclinique de Grande-Synthe Recruiting
Grande Synthe, France, 59760
Sub-Investigator: Philippe Debondinance, MD         
CH de la Rochelle Recruiting
La Rochelle Cedex, France, 17019
Sub-Investigator: Philippe Ferry, MD         
APHP - Centre Hospitalier Universitaire de Bicêtre Recruiting
Le Kremlin Bicêtre Cedex, France, 94275
Sub-Investigator: Hervé Fernandez, MD PhD         
CHRU de Lille - Hôpital Jeanne de Flandre Recruiting
Lille Cedex, France, 59037
Sub-Investigator: Jean-Philippe Lucot, MD         
CHU de Nîmes - Hôpital Universitaire Carémeau Recruiting
Nîmes Cedex 9, France, 30029
Principal Investigator: Brigitte Fatton, MD         
Sub-Investigator: Renaud de Tayrac, MD PhD         
Groupe Hospitalier Dioconesses - Site Reuilly Recruiting
Paris, France, 75012
Sub-Investigator: Delphine Salet-Lizee, MD         
APHP - Hôpital Bichat - Claude Bernard Recruiting
Paris Cedex 18, France, 75877
Sub-Investigator: Jean-François Hermieu, MD         
CHU de Poitiers Recruiting
Poitiers Cedex, France, 86021
Sub-Investigator: Xavier Fritel, MD PhD         
CH de la Région d'Annecy Recruiting
Pringy Cedex, France, 74374
Sub-Investigator: Sébastien Blanc, MD         
CH de Poissy - Saint-Germain-en-Laye Recruiting
Saint-Germain-en-Laye, France, 78100
Sub-Investigator: Arnaud Fauconnier, MD PhD         
CHRU de Strasbourg - Hôpital de Hautepierre Recruiting
Strasbourg, France, 67098
Sub-Investigator: Arnaud Wattiez, MD PhD         
Hôpital Foch Recruiting
Suresnes, France, 92151
Sub-Investigator: Florence Cour, MD         
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

No publications provided

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: November 3, 2014
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:
Fecal Incontinence
Pelvic Organ Prolapse
Prolapse
Urinary Incontinence
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Lower Urinary Tract Symptoms
Pathological Conditions, Anatomical
Rectal Diseases
Signs and Symptoms
Urination Disorders
Urologic Diseases
Urological Manifestations

ClinicalTrials.gov processed this record on November 27, 2014