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Clinical Trials/NCT01632839
NCT01632839
Completed
N/A

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

Centre Hospitalier Universitaire de Nīmes14 sites in 1 country298 target enrollmentJanuary 18, 2013

Overview

Phase
N/A
Intervention
Not specified
Conditions
Sexuality
Sponsor
Centre Hospitalier Universitaire de Nīmes
Enrollment
298
Locations
14
Primary Endpoint
PISQ-R questionnaire
Status
Completed
Last Updated
5 months ago

Overview

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).

Registry
clinicaltrials.gov
Start Date
January 18, 2013
End Date
April 20, 2017
Last Updated
5 months ago
Study Type
Observational
Sex
Female

Investigators

Sponsor
Centre Hospitalier Universitaire de Nīmes
Responsible Party
Sponsor

Eligibility 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

Outcomes

Primary Outcomes

PISQ-R questionnaire

Time Frame: 12 months + 1 week

Secondary Outcomes

  • FSFI questionnaire(12 months)
  • PGI-I questionnaire(12 months)
  • PISQ-R questionnaire(12 months)
  • New sexuality questionnaire(12 months + 1 week)
  • PFDI questionnaire(12 months)
  • ICI-Q questionnaire(12 months)

Study Sites (14)

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