A Multi Center Study to Validate a Condition-specific Measure of Sexual Health in Women With Pelvic Floor Disorders

Study Overview
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Brief Summary
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Study Aims: To validate a new measure of sexual function and activity in women with PFDs; To establish the responsiveness to change of the new measure. The investigators hypothesis is that the investigators can create a new questionnaire that accurately measures sexual health in women with pelvic floor disorders that improves on the already published questionnaires.

Detailed Description
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600 women presenting for care to urogynecology clinics in the United States and England will be recruited to participate. They will give data regarding their physical exam, including measurements by the Pelvic Organ Prolapse Quantification exam and medical and surgical history. In addition, they will complete validated questionnaires including the Incontinence Severity Index, the Pelvic Floor Distress Inventory (short form) and question # 35 from the Epidemiology of Prolapse and Incontinence Questionnaire. All women will also complete two sexual health questionnaires; the Female Sexual Function Index and the Pelvic Organ Prolapse Urinary Incontinence Sexual Questionnaire (Revised). Women will receive standard care for their pelvic floor disorders. They will then be recontacted to repeat the same set of questionnaires to determine the responsiveness of the new measure. Reliability of the questionnaire will be measured by having a subset of women complete the questionnaire twice; a factor analysis will be performed to determine the underlying factor structure. Responses to the other QOL measures will be compared to those to the new instrument to establish validity.

Official Title
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A Multi Center Study to Validate a Condition-specific Measure of Sexual Health in Women With Pelvic Floor Disorders

Conditions
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Pelvic Floor Disorders, Sexual Dysfunction, Incontinence, Pelvic Organ Prolapse

Intervention / Treatment
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* Other: Survey


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Inclusion criteria for patients include age over 18 years. Not pregnant. Able to read/write and understand English. And, because this is a project to validate a measure of female sexual function, all subjects will be women. All women will be seeking care for PFD including urinary and anal incontinence and POP. Since data collection will primarily be by mail Women must have a stable and current address. Exclusion Criteria: Women under the age of 18. Are pregnant or who are unable to read/write or understand English will not be eligible for participation. In addition, women with a diagnosis of vulvodynia, painful bladder syndrome, or chronic pelvic pain (defined as pelvic pain for greater than 6 months) as determined by the consenting physician will be excluded. Since this is a study to evaluate both sexual activity status as well as sexual function, women need not be sexually active to participate.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Survey of Women PFDs<br>Women with PFDs | Other: Survey<br>* This is a study to develop a survey for sexual health in women with pelvic floor dysfunction<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The primary outcome measure for this study is the creation of a valid and reliable new measure of sexual health in women with pelvic floor disorders. |  | 3-5 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pelvic Floor Disorders, Sexual Function, Incontinence, Pelvic Organ Prolapse