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

Completed

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

In brief

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.

Key facts

Study ID

NCT00952406

Run by

International Urogynecological Society

People needed

877

Starts

2009-08-01

Expected to finish

2012-08-01

Last updated by the study team

2015-12-14

Who can join

Age: 18 and older, up to 100. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• 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
• The Warrell Unit, Whitworth Park — Manchester, United Kingdom
• Northwick Park and St Marks Hospital — Middlesex, United Kingdom
• Royal Hallamshire Hospital — Sheffield, United Kingdom
• Mayday University Hospital — Surrey, United Kingdom

Full record on ClinicalTrials.gov

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