Sexual Dysfunctions, PsychologicalNCT00148200
Female Sexual Dysfunction: Prevalence Among Italian Healthy Women
An observational study of Sexual Dysfunctions, Psychological, run by Unita Complessa di Ostetricia e Ginecologia at 1 site in Italy.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Sexual Dysfunctions, Psychological
- How many people
- 500 participants
- Where
- 1 siteItaly
- Study dates
- Feb 2005to Feb 2007
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: n° 500 Female outpatient coming to Gynecology Clinic
Who may be able to join
- Female outpatient coming to Gynecology Clinic
- Age >18
Who cannot join
- Pregnancy
- Never had sexual activity
Trial locations and contacts
1 site in 1 country.
Italy1 site
Clinic of Obstetrics and Gynecology - S. Orsola Hospital
Bologna, 40138
About this study
Official title: Prevalence of Female Sexual Dysfunctions Among Healthy Women Coming to the University of Bologna Gynecology Clinic as Outpatients.
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
Read the 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 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.
- Conditions
- Sexual Dysfunctions, Psychological
- Keywords
- female sexual dysfunction, desire, arousal, lubrification, orgasm, satisfaction, pain
- Medical subject headings
- Sexual Dysfunctions, Psychological, Orgasm, Personal Satisfaction, Pain
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2005 (estimated)
- Study startFeb 2005
- Primary completionNov 2006
- Study completionFeb 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Sexual Dysfunctions, PsychologicalStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 500 participants (actual)
Sponsor and investigators
- Lead sponsor
- Unita Complessa di Ostetricia e Ginecologia
- Sponsor type
- University, hospital or other
- Investigators
- Maria Cristina Meriggiola, MD, Principal investigator, University of Bologna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00148200
- Sponsor's protocol ID
- FSD/2005
- Status last verified
- Feb 2009
- First submitted
- 2 Sep 2005
- Last updated
- 18 Feb 2009
- Results posted
- No
Publications
Laumann EO, Paik A, Rosen RC. Sexual dysfunction in the United States: prevalence and predictors. JAMA. 1999 Feb 10;281(6):537-44. doi: 10.1001/jama.281.6.537.
PubMed 10022110Basson R, Berman J, Burnett A, Derogatis L, Ferguson D, Fourcroy J, Goldstein I, Graziottin A, Heiman J, Laan E, Leiblum S, Padma-Nathan H, Rosen R, Segraves K, Segraves RT, Shabsigh R, Sipski M, Wagner G, Whipple B. Report of the international consensus development conference on female sexual dysfunction: definitions and classifications. J Urol. 2000 Mar;163(3):888-93.
PubMed 10688001Berman JR, Berman LA, Werbin TJ, Goldstein I. Female sexual dysfunction: anatomy, physiology, evaluation and treatment options. Curr Opin Urol. 1999 Nov;9(6):563-8. doi: 10.1097/00042307-199911000-00012.
PubMed 10668578Geiss IM, Umek WH, Dungl A, Sam C, Riss P, Hanzal E. Prevalence of female sexual dysfunction in gynecologic and urogynecologic patients according to the international consensus classification. Urology. 2003 Sep;62(3):514-8. doi: 10.1016/s0090-4295(03)00487-4.
PubMed 12946757Abdo CH, Oliveira WM Jr, Moreira ED Jr, Fittipaldi JA. Prevalence of sexual dysfunctions and correlated conditions in a sample of Brazilian women--results of the Brazilian study on sexual behavior (BSSB). Int J Impot Res. 2004 Apr;16(2):160-6. doi: 10.1038/sj.ijir.3901198.
PubMed 14961047Najman JM, Dunne MP, Boyle FM, Cook MD, Purdie DM. Sexual dysfunction in the Australian population. Aust Fam Physician. 2003 Nov;32(11):951-4.
PubMed 14650796Salonia A, Munarriz RM, Naspro R, Nappi RE, Briganti A, Chionna R, Federghini F, Mirone V, Rigatti P, Goldstein I, Montorsi F. Women's sexual dysfunction: a pathophysiological review. BJU Int. 2004 May;93(8):1156-64. doi: 10.1111/j.1464-410X.2004.04796.x. No abstract available.
PubMed 15142131Rosen R, Brown C, Heiman J, Leiblum S, Meston C, Shabsigh R, Ferguson D, D'Agostino R Jr. The Female Sexual Function Index (FSFI): a multidimensional self-report instrument for the assessment of female sexual function. J Sex Marital Ther. 2000 Apr-Jun;26(2):191-208. doi: 10.1080/009262300278597.
PubMed 10782451Wiegel M, Meston C, Rosen R. The female sexual function index (FSFI): cross-validation and development of clinical cutoff scores. J Sex Marital Ther. 2005 Jan-Feb;31(1):1-20. doi: 10.1080/00926230590475206.
PubMed 15841702Bancroft J, Loftus J, Long JS. Distress about sex: a national survey of women in heterosexual relationships. Arch Sex Behav. 2003 Jun;32(3):193-208. doi: 10.1023/a:1023420431760.
PubMed 12807292Lightner DJ. Female sexual dysfunction. Mayo Clin Proc. 2002 Jul;77(7):698-702. doi: 10.4065/77.7.698.
PubMed 12108607
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence of Female Sexual Dysfunctions Among Healthy Women Coming to the University of Bologna Gynecology Clinic as Outpatients.
- ClinicalTrials.gov ID
- NCT00148200
- Acronym / sponsor ID
- FSD/2005
- Conditions
- Sexual Dysfunctions, Psychological
- Keywords
- female sexual dysfunction, desire, arousal, lubrification, orgasm, satisfaction, pain
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 500 participants (actual)
- Lead sponsor
- Unita Complessa di Ostetricia e GinecologiaUniversity, hospital or other
- Study start
- Feb 2005
- Primary completion
- Nov 2006 (actual)
- Study completion
- Feb 2007 (actual)
- First posted
- 7 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 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.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- n° 500 Female outpatient coming to Gynecology Clinic
Key inclusion criteria (2 listed)
- Female outpatient coming to Gynecology Clinic
- Age >18
Key exclusion criteria (2 listed)
- Pregnancy
- Never had sexual activity
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2009.
- Background: PubMed 10022110Laumann EO, Paik A, Rosen RC. Sexual dysfunction in the United States: prevalence and predictors. JAMA. 1999 Feb 10;281(6):537-44. doi: 10.1001/jama.281.6.537.
- Background: PubMed 10688001Basson R, Berman J, Burnett A, Derogatis L, Ferguson D, Fourcroy J, Goldstein I, Graziottin A, Heiman J, Laan E, Leiblum S, Padma-Nathan H, Rosen R, Segraves K, Segraves RT, Shabsigh R, Sipski M, Wagner G, Whipple B. Report of the international consensus development conference on female sexual dysfunction: definitions and classifications. J Urol. 2000 Mar;163(3):888-93.
- Background: PubMed 10668578Berman JR, Berman LA, Werbin TJ, Goldstein I. Female sexual dysfunction: anatomy, physiology, evaluation and treatment options. Curr Opin Urol. 1999 Nov;9(6):563-8. doi: 10.1097/00042307-199911000-00012.
- Background: PubMed 12946757Geiss IM, Umek WH, Dungl A, Sam C, Riss P, Hanzal E. Prevalence of female sexual dysfunction in gynecologic and urogynecologic patients according to the international consensus classification. Urology. 2003 Sep;62(3):514-8. doi: 10.1016/s0090-4295(03)00487-4.
- Background: PubMed 14961047Abdo CH, Oliveira WM Jr, Moreira ED Jr, Fittipaldi JA. Prevalence of sexual dysfunctions and correlated conditions in a sample of Brazilian women--results of the Brazilian study on sexual behavior (BSSB). Int J Impot Res. 2004 Apr;16(2):160-6. doi: 10.1038/sj.ijir.3901198.
- Background: PubMed 14650796Najman JM, Dunne MP, Boyle FM, Cook MD, Purdie DM. Sexual dysfunction in the Australian population. Aust Fam Physician. 2003 Nov;32(11):951-4.
- Background: PubMed 15142131Salonia A, Munarriz RM, Naspro R, Nappi RE, Briganti A, Chionna R, Federghini F, Mirone V, Rigatti P, Goldstein I, Montorsi F. Women's sexual dysfunction: a pathophysiological review. BJU Int. 2004 May;93(8):1156-64. doi: 10.1111/j.1464-410X.2004.04796.x. No abstract available.
- Background: PubMed 10782451Rosen R, Brown C, Heiman J, Leiblum S, Meston C, Shabsigh R, Ferguson D, D'Agostino R Jr. The Female Sexual Function Index (FSFI): a multidimensional self-report instrument for the assessment of female sexual function. J Sex Marital Ther. 2000 Apr-Jun;26(2):191-208. doi: 10.1080/009262300278597.
- Background: PubMed 15841702Wiegel M, Meston C, Rosen R. The female sexual function index (FSFI): cross-validation and development of clinical cutoff scores. J Sex Marital Ther. 2005 Jan-Feb;31(1):1-20. doi: 10.1080/00926230590475206.
- Background: PubMed 12807292Bancroft J, Loftus J, Long JS. Distress about sex: a national survey of women in heterosexual relationships. Arch Sex Behav. 2003 Jun;32(3):193-208. doi: 10.1023/a:1023420431760.
- Background: PubMed 12108607Lightner DJ. Female sexual dysfunction. Mayo Clin Proc. 2002 Jul;77(7):698-702. doi: 10.4065/77.7.698.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Maria Cristina Meriggiola, MD principal investigator
University of Bologna
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sexual Dysfunctions, Psychological, run by Unita Complessa di Ostetricia e Ginecologia at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Feb 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00148200, which also lists 11 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Feb 2009.