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

International Urogynecological Society

Status: Completed

Conditions: Pelvic Floor Disorders; Pelvic Organ Prolapse; Sexual Dysfunction; Incontinence

Treatments: Other: Survey

Study type: Observational

Funder types: Other

Identifiers

NCT00952406

IUGA -1 - 09

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 877 patients

Sex: Female

Ages: 18 to 100 years old

Volunteers: No Healthy Volunteers

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.

Trial design

877 participants in 1 patient group

Survey of Women PFDs

Description:

Women with PFDs

Treatment:

Other: Survey