Status:
COMPLETED
A Multi Center Study to Validate a Condition-specific Measure of Sexual Health in Women With Pelvic Floor Disorders
Lead Sponsor:
International Urogynecological Society
Conditions:
Pelvic Floor Disorders
Sexual Dysfunction
Eligibility:
FEMALE
18-100 years
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...
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 t...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
August 1 2009
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
August 1 2012
Estimated Enrollment :
877 Patients enrolled
Trial Details
Trial ID
NCT00952406
Start Date
August 1 2009
End Date
August 1 2012
Last Update
December 14 2015
Active Locations (14)
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1
UCSD women's Pelvic Medicine Center
San Diego, California, United States, 92037
2
Northwestern University Feinburg School of Medicine
Evanston, Illinois, United States, 60611
3
MetroUrology
Minneapolis, Minnesota, United States, 55441
4
University of New Mexico
Albuquerque, New Mexico, United States, 87131