An observational study in Sexual Dysfunctions, Psychological, sponsored by Unita Complessa di Ostetricia e Ginecologia. Completed at 1 site in Italy. Open to female participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2009-02-18.
Sponsored by Unita Complessa di Ostetricia e Ginecologia · Observational
Purposes of this study are:
BACKGROUND:
Female Sexual Dysfunctions (FSD) are a relatively new field of study as are possible interventions. Until recently FSD were regarded as only a psychological matter and consequently the exact definition of the problem was to some extent controversial. Things have changed and now we refer to FSD according to the classification decided during the International Consensus development Conference on FSD (Basson et al, 2000). There are 5 major categories of FSD: Sexual Desire Disorders, Sexual Arousal Disorders, Orgasmic Disorders, Sexual Pain Disorders. A woman can be considered sexually dysfunctional if she has one or more of these disorders and if she feels uncomfortable about them.
Recent studies completed abroad show the prevalence of FSD to be extremely high: from 38% to 63% of women interviewed about their sexuality have complaints about it.
RATIONALE:
So far, in Italy there are no studies showing the prevalence of FSD among healthy women. We have no reasons to think that the results will demonstrate lower percentages than those found abroad indicating therefore a high number of women complaining about their sexuality.
To define the prevalence of alteration in sexual function we decided to use a questionnaire that would explore all the area included in the definition of FSD. We chose the Female Sexual Function Index (Rosen et al, 2000). This is commonly recognized as a reliable and specific instrument. Moreover there is a validated Italian translation of it.
Women coming to the Gynecologic Clinic for routine examination represent in our opinion a realistic sample of Italian female population.
Complete anonymity will be guaranteed for the entire study to every woman filling out the questionnaire.
During this study we will try to answer the following questions:
DESIGN:
In order to answer these questions the study will be organized as follow
MATERIALS AND METHODS:
The FSFI is a multidimensional questionnaire organized into 19 multiple-choice questions and divided in 6 domains which explore sexual desire, arousal, vaginal lubrication, satisfaction and sexual pain. It contains questions about sexual life in the previous 4 weeks. Each answer is given a score between 0 and 5. The final total score gives the result of the test, when it's lower than 26.5 (Wiegel et al, 2005) it suggests a possible sexual dysfunction. FSFI is easily understandable and the time required to complete it is less than 5 minutes.
In our study the FSFI Questionnaire is utilized in conjunction with anonymous questions about age, marital/partner status, duration of relationship, current and past clinical complains, reason for coming to the Gynecologic Clinic and menopause. These will give us the instruments to evaluate whether these factors can influence the presence of FSD and which domains they affect the most.
The questionnaires will be handled by medical staff. The research subjects will be reassured about the anonymity of the study, will be invited to leave the completed FSFI in the collection boxes.
SELECTION OF STUDY POPULATION Selecting women coming for routing testing/exams at the Gynecology Clinic gives us the chance to have our questionnaires completed by a broad sample of women. At least in Italy, where the National Health System guarantees an easy and affordable access to sanitary services, women of all ages and social classes periodically come to clinic to have their gynecologic exam or pap test done. Therefore, even if selected inside a clinic our female sample can reasonably be considered a realistic example of the general female population.
117 studies on the registry are indexed under Sexual Dysfunctions, Psychological; 8 are open to participants now.
This study's enrollment of 500 is above the median of 300 across 13 observational studies indexed under Sexual Dysfunctions, Psychological.
Browse Sexual Dysfunctions, Psychological studies →Unita Complessa di Ostetricia e Ginecologia is the lead sponsor of 4 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
n° 500 Female outpatient coming to Gynecology Clinic
Exclusion Criteria:
This study is completed, as verified in Feb 2009. You cannot join it, but the record below documents what was studied.
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Unita Complessa di Ostetricia e Ginecologia