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

Completed

• Conditions: Pelvic Floor Disorders; Pelvic Organ Prolapse; Sexual Dysfunction; Incontinence
• Interventions: Other: Survey

• Registration Number: NCT00952406
• Lead Sponsor: International Urogynecological Society

Brief Summary

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.

Detailed 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.

Study Timeline

• Study Start: 2009-08
• Study First Submitted: 2009-08-04
• Study First Submitted QC: 2009-08-05
• Study First Posted: 2009-08-06
• Primary Completion: 2012-08
• Study Completion: 2012-08
• Status Verified: 2015-12
• Last Update Submitted: 2015-12-10
• Last Update Posted: 2015-12-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 877

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Survey of Women PFDs	Survey	Women with PFDs

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (14)

UCSD women's Pelvic Medicine Center; 🇺🇸 San Diego, California, United States

Cleveland Clinic Lerner College of Medicine; 🇺🇸 Cleveland, Ohio, United States

Northwestern University Feinburg School of Medicine; 🇺🇸 Evanston, Illinois, United States

MetroUrology; 🇺🇸 Minneapolis, Minnesota, United States

Genesis Health System; 🇺🇸 Zanesville, Ohio, United States

The Warrell Unit, Whitworth Park; 🇬🇧 Manchester, United Kingdom

Geisinger Health Systems; 🇺🇸 Danville, Pennsylvania, United States

Center for Female Sexual Health; 🇺🇸 Cincinatti, Ohio, United States

Chelsea and Westminster Hospital; 🇬🇧 London, United Kingdom

Women's Pelvic Speciality Care PC; 🇺🇸 Albuquerque, New Mexico, United States

Royal Hallamshire Hospital; 🇬🇧 Sheffield, United Kingdom

Northwick Park and St Marks Hospital; 🇬🇧 Middlesex, United Kingdom

Mayday University Hospital; 🇬🇧 Surrey, United Kingdom

University of New Mexico; 🇺🇸 Albuquerque, New Mexico, United States