Linguistic and Cultural Validation in Italian of Female Sexual Function Index (FSFI) Questionnaire

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. Identifier: NCT01252576
Recruitment Status : Unknown
Verified June 2011 by Club Italiano Femminile di Urologia.
Recruitment status was:  Active, not recruiting
First Posted : December 3, 2010
Last Update Posted : June 22, 2011
Società Italiana di Urologia (SIU)
Information provided by:
Club Italiano Femminile di Urologia

Brief Summary:
300 italian women will be enroll for linguistic and cultural validation in italian of Female sexual function index (FSFI). This questionnaire is used in most countries to investigate female sexual function. To date there are not validate questionnaires in italian on female sexual function. We decided to start the validation process to give a validated tool to italian investigators.

Condition or disease
Sexual Dysfunction

Detailed Description:
A linguistic translation from the original language into the target language (Italian) will be carried out in parallel by two independent, native Italian-speaking professional translators, with English as their first foreign language. A first consensus meeting, which will involve the two translators and the research group, to compare the Italian versions and yielded a first-consensus Italian version of the scale. After this first phase the study will conduct in multiple Italian centres located in Northern, Central and Southern Italy. At each centre, the FSFI will administer to a female population of subjects with and without sexual dysfunction. Women will be administer the questionnaire at baseline and 2 weeks later, so as to evaluate the test-retest reliability. The patients will ask whether encountered any difficulty (ease of completion, comprehension, problems, etc). The number of patients who will encounter problems in correctly understanding questions and precoded answers will be recorded and discussed. Will also ask the women to indicate the way to ameliorate the test, and, if possible, the changes will be performed. A back-translation of the Italian consensus version will be carried out by a native American English-speaking professional translator, with Italian as her first foreign language, to control the adherence of translation with the original one. The final Italian version of the FSFI will be obtained.

Study Type : Observational
Estimated Enrollment : 300 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Linguistic and Cultural Validation in Italian of Female Sexual Function Index Questionnaire (FSFI)
Study Start Date : December 2010
Actual Primary Completion Date : June 2011

women with and without sexual dysfunction
women with and without female sexual dysfunction

Primary Outcome Measures :
  1. Test-retest reliability of FSFI italian translation [ Time Frame: 15 days ]
    Test-retest reliability of professional translation in italian language of female sexual function index test.

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
women from general population whit or without sexual dysfunction

Inclusion Criteria:

  • women aged 18-65 years

Exclusion Criteria:

  • mental diseases that do not permit to understand questionnaire

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 identifier (NCT number): NCT01252576

SS Annunziata Hospital
Savigliano, Cuneo, Italy, 12030
Sponsors and Collaborators
Club Italiano Femminile di Urologia
Società Italiana di Urologia (SIU)
Principal Investigator: Maria Teresa Filocamo, MD Club Italiano Femminile di Urologia

Responsible Party: D.ssa Donata Villari, CIFU Identifier: NCT01252576     History of Changes
Other Study ID Numbers: 1-Villari
First Posted: December 3, 2010    Key Record Dates
Last Update Posted: June 22, 2011
Last Verified: June 2011

Keywords provided by Club Italiano Femminile di Urologia:
female sexual function
italian validation