Ignite Creation Date:
2024-05-05 @ 11:50 AM
Last Modification Date:
2024-10-26 @ 9:14 AM
Study NCT ID:
NCT00148200
Status:
COMPLETED
Last Update Posted:
2009-02-18
First Post:
2005-09-02
Brief Title:
Female Sexual Dysfunction Prevalence Among Italian Healthy Women
Sponsor:
Unita Complessa di Ostetricia e Ginecologia
Organization:
Unita Complessa di Ostetricia e Ginecologia
Study Overview
Official Title:
Prevalence of Female Sexual Dysfunctions Among Healthy Women Coming to the University of Bologna Gynecology Clinic as Outpatients
Status:
COMPLETED
Status Verified Date:
2009-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Purposes of this study are
To determine the prevalence of female sexual dysfunctions among Italian general population
To determine which sexual domains are more frequently compromised
To evaluate which of the factors we took into consideration are more frequently associated with FSD
To determine the prevalence of female sexual dysfunctions among Italian general population
To determine which sexual domains are more frequently compromised
To evaluate which of the factors we took into consideration are more frequently associated with FSD
Detailed Description:
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
What is the prevalence of FSD among healthy Italian women
Which domains of sexuality are most frequently compromised
Which among the following factors effect the most sexual functions
Age
Menopause
Stable relationship
Duration and quality of relationship
Clinical background
Reasons for coming to the gynecologic clinic
DESIGN
In order to answer these questions the study will be organized as follow
Request for approval of the study from the local board
Distribution of the FSFI Questionnaire to female outpatient of the Bologna University Gynecologic Clinic We are planning to hand ouas many questionnaires as needed to have a minimum of 500 questionnaires completed
Registration and analysis of the data from the questionnaires
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 its lower than 265 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 maritalpartner 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 testingexams 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
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
What is the prevalence of FSD among healthy Italian women
Which domains of sexuality are most frequently compromised
Which among the following factors effect the most sexual functions
Age
Menopause
Stable relationship
Duration and quality of relationship
Clinical background
Reasons for coming to the gynecologic clinic
DESIGN
In order to answer these questions the study will be organized as follow
Request for approval of the study from the local board
Distribution of the FSFI Questionnaire to female outpatient of the Bologna University Gynecologic Clinic We are planning to hand ouas many questionnaires as needed to have a minimum of 500 questionnaires completed
Registration and analysis of the data from the questionnaires
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 its lower than 265 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 maritalpartner 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 testingexams 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None