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

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.

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.