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Validation of a New Sexuality Questionnaire for Patients With Urinary Incontinence or Pelvic Organ Prolapse

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01548989
First Posted: March 8, 2012
Last Update Posted: March 26, 2015
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.
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Nīmes
  Purpose
The main objective of this study is to perform the linguistic validation of a new french questionnaire in a population of sexually active (or not) patients who have undergone surgery (or not) for stress urinary incontinence or genital prolapse.

Condition
Pelvic Organ Prolapse Urinary Incontinence Fecal Incontinence

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Cross-Sectional
Official Title: Validation of a New Sexuality Questionnaire: a Tool for Evaluating the Sexuality of Patients With 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:
  • Patient comprehension [ Time Frame: Baseline (Day 0; transversal study) ]
    These tests assess patient understanding of the original formulation and patient understanding of the various terms used: a list of proposed rewording suggested by patients is made.


Enrollment: 25
Study Start Date: April 2012
Study Completion Date: July 2012
Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
The study population
Patients suffering from pelvic organ prolapse and/or urinary incontinence and/or fecal incontinence. See inclusion/exclusion criteria.

  Eligibility

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 suffering from pelvic organ prolapse and/or urinary incontinence and/or fecal incontinence.
Criteria

Inclusion Criteria:

  • The patient is able to read and understand French
  • The patient must be insured or beneficiary of a health insurance plan
  • Patients suffering from pelvic organ prolapse and/or urinary incontinence and/or fecal incontinence.

Exclusion Criteria:

  • Patient is pregnant
  • The patient is under judicial protection, under tutorship or curatorship
  • The patient does not understand French
  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): NCT01548989


Locations
France
CHU de Nîmes - Hôpital Universitaire Carémeau
Nîmes Cedex 09, Gard, France, 30029
Sponsors and Collaborators
Centre Hospitalier Universitaire de Nīmes
Investigators
Principal Investigator: Brigitte Fatton, MD Centre Hospitalier Universitaire de Nîmes
  More Information

Responsible Party: Centre Hospitalier Universitaire de Nīmes
ClinicalTrials.gov Identifier: NCT01548989     History of Changes
Other Study ID Numbers: LOCAL/2011/BF-02
2012-A00134-39 ( Other Identifier: RCB number )
First Submitted: February 29, 2012
First Posted: March 8, 2012
Last Update Posted: March 26, 2015
Last Verified: March 2015

Keywords provided by Centre Hospitalier Universitaire de Nīmes:
linguistic validation of a new 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