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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01632839
Recruitment Status : Active, not recruiting
First Posted : July 3, 2012
Last Update Posted : April 6, 2016
Sponsor:
Information provided by (Responsible Party):

Study Description
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).

Condition or disease
Sexuality Pelvic Organ Prolapse Urinary Incontinence Fecal Incontinence

Study Design

Study Type : Observational
Actual Enrollment : 298 participants
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
Study Start Date : January 2013
Estimated Primary Completion Date : March 2017
Estimated Study Completion Date : March 2017

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts

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.


Outcome Measures

Primary Outcome Measures :
  1. PISQ-R questionnaire [ Time Frame: 12 months + 1 week ]

Secondary Outcome Measures :
  1. PISQ-R questionnaire [ Time Frame: baseline; day 0 ]
  2. PISQ-R questionnaire [ Time Frame: 6 months ]
  3. PISQ-R questionnaire [ Time Frame: 12 months ]
  4. New sexuality questionnaire [ Time Frame: baseline; day 0 ]
  5. New sexuality questionnaire [ Time Frame: 6 months ]
  6. New sexuality questionnaire [ Time Frame: 12 months ]
  7. New sexuality questionnaire [ Time Frame: 12 months + 1 week ]
  8. PFDI questionnaire [ Time Frame: baseline; day 0 ]
  9. PFDI questionnaire [ Time Frame: 6 months ]
  10. PFDI questionnaire [ Time Frame: 12 months ]
  11. ICI-Q questionnaire [ Time Frame: baseline; day 0 ]
  12. ICI-Q questionnaire [ Time Frame: 6 months ]
  13. ICI-Q questionnaire [ Time Frame: 12 months ]
  14. FSFI questionnaire [ Time Frame: baseline; day 0 ]
  15. FSFI questionnaire [ Time Frame: 6 months ]
  16. FSFI questionnaire [ Time Frame: 12 months ]
  17. PGI-I questionnaire [ Time Frame: baseline; day 0 ]
  18. PGI-I questionnaire [ Time Frame: 6 months ]
  19. PGI-I questionnaire [ Time Frame: 12 months ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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 ( Other Identifier: RCB number )
First Posted: July 3, 2012    Key Record Dates
Last Update Posted: April 6, 2016
Last Verified: April 2016

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