Study Aims: 1. To validate a new measure of sexual function and activity in women with PFDs; 2. 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.
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.
Study Type
OBSERVATIONAL
Enrollment
877
This is a study to develop a survey for sexual health in women with pelvic floor dysfunction
UCSD women's Pelvic Medicine Center
San Diego, California, United States
Northwestern University Feinburg School of Medicine
Evanston, Illinois, United States
MetroUrology
Minneapolis, Minnesota, United States
University of New Mexico
Albuquerque, New Mexico, United States
Women's Pelvic Speciality Care PC
Albuquerque, New Mexico, United States
Center for Female Sexual Health
Cincinnati, Ohio, United States
Cleveland Clinic Lerner College of Medicine
Cleveland, Ohio, United States
Genesis Health System
Zanesville, Ohio, United States
Geisinger Health Systems
Danville, Pennsylvania, United States
Chelsea and Westminster Hospital
London, United Kingdom
...and 4 more locations
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.
Time frame: 3-5 months
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