This trial is active, not recruiting.

Condition sexual dysfunction
Sponsor Club Italiano Femminile di Urologia
Collaborator Società Italiana di Urologia (SIU)
Start date December 2010
End date June 2011
Trial size 300 participants
Trial identifier NCT01252576, 1-Villari


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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective
women with and without female sexual dysfunction

Primary Outcomes

Test-retest reliability of FSFI italian translation
time frame: 15 days

Eligibility Criteria

Female participants from 18 years up to 65 years old.

Inclusion Criteria: - women aged 18-65 years Exclusion Criteria: - mental diseases that do not permit to understand questionnaire

Additional Information

Official title Linguistic and Cultural Validation in Italian of Female Sexual Function Index Questionnaire (FSFI)
Principal investigator Maria Teresa Filocamo, MD
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.
Trial information was received from ClinicalTrials.gov and was last updated in June 2011.
Information provided to ClinicalTrials.gov by Club Italiano Femminile di Urologia.