Female Sexual Dysfunction, Risks and Outcomes (FSFI) (FSFI)

Many women will likely experience a sexual problem in their lifetimes. The Prevalence of Female Sexual Problems Associated with Distress and Determinants of Treatment Seeking (PRESIDE) study surveyed more than 30,000 U.S. women aged >18 years regarding sexual function. Results from this study estimated that 12% of women experience a diagnosable sexual disorder that causes personal distress, with lack of sexual desire being the most prevalent. - See more at: http://www.uspharmacist.com/content/d/featured_articles/c/56908/#sthash.LTDkyRlR.dpuf

Study Overview

• Status: Withdrawn
• Conditions: Female Sexual Dysfunction

Detailed Description

Standard of care includes completion of a sexual dysfunctional questionnaire at every visit. This study will collect information from the questionnaires and office visit and follow the patient for outcomes of successful or non successful treatment.

The purpose of this study is to collect and analyze data on the characteristics of women who present with sexual dysfunction, to evaluate what risk factors contribute to sexual dysfunction and to evaluate what factors contribute to successful treatment of sexual dysfunction.

Upon a visit to the office participants will complete the Female Sexual Function Index (FSFI), this is standard of care for all patients. Research related procedures include: Review of questionnaires and collecting data from medical records regarding medical history, and treatment outcomes. If a participant does not return to the office for a follow up visit (or final visit) the final questionnaire will be sent by their preference (e-mail, phone, or mail) noted in the consent form.

Participates will also be given the option of participating in a "future storage of data". Future testing will be in the area of female sexual dysfunction. Data will be identified by a code number and only the research staff at Saint Louis University will have access to the data.

• Study Type: Observational

Contacts and Locations

Study Locations

• United States
  • Missouri
    • St. Louis, Missouri, United States, 63117
      • St. Mary's Health Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 89 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Probability Sample

Study Population

Many women will likely experience a sexual problem in their lifetimes. The Prevalence of Female Sexual Problems Associated with Distress and Determinants of Treatment Seeking (PRESIDE) study surveyed more than 30,000 U.S. women aged >18 years regarding sexual function. Results from this study estimated that 12% of women experience a diagnosable sexual disorder that causes personal distress, with lack of sexual desire being the most prevalent

Description

Inclusion Criteria:

Female 18 to 89 years of age Being treated at the Saint Louis University Clinic for Sexual Dysfunction

Exclusion Criteria:

None

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Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of women with similar characteristics	Categorical variables will be expressed as frequencies and percentages. Continuous variables will be expressed as means and standard deviations and/or medians and ranges. Parametric and nonparametric statistical analysis will be conducted based on normality of distributions.	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of women with history of risk factors contribute to sexual dysfunction	Categorical variables will be expressed as frequencies and percentages. Continuous variables will be expressed as means and standard deviations and/or medians and ranges. Parametric and nonparametric statistical analysis will be conducted based on normality of distributions.	1 year
Number of women with successful treatment of sexual dysfunction.	Categorical variables will be expressed as frequencies and percentages. Continuous variables will be expressed as means and standard deviations and/or medians and ranges. Parametric and nonparametric statistical analysis will be conducted based on normality of distributions.	1 year

Collaborators and Investigators

• Sponsor: St. Louis University

Study record dates

Study Major Dates

• Study Start: July 1, 2016
• Primary Completion (ACTUAL): January 1, 2017
• Study Completion (ACTUAL): January 1, 2017

Study Registration Dates

• First Submitted: August 2, 2016
• First Submitted That Met QC Criteria: August 4, 2016
• First Posted (ESTIMATE): August 10, 2016

Study Record Updates

• Last Update Posted (ESTIMATE): January 13, 2017
• Last Update Submitted That Met QC Criteria: January 12, 2017
• Last Verified: January 1, 2017

More Information

Terms related to this study

• Other Study ID Numbers: 26311

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO