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

Sponsor

International Urogynecological Society (Other)

Overall Status

Completed

CT.gov ID

NCT00952406

Collaborator

(none)

877

Enrollment

Locations

Duration (Months)

62.6

Patients Per Site

1.7

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Study Aims:

To validate a new measure of sexual function and activity in women with PFDs;
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.

Condition or Disease	Intervention/Treatment	Phase
Pelvic Floor Disorders Sexual Dysfunction Incontinence Pelvic Organ Prolapse	Other: Survey

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 Design

Study Type:

Observational

Actual Enrollment :

877 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Study Start Date :

Aug 1, 2009

Actual Primary Completion Date :

Aug 1, 2012

Actual Study Completion Date :

Aug 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Survey of Women PFDs Women with PFDs	Other: Survey This is a study to develop a survey for sexual health in women with pelvic floor dysfunction

Arm

Intervention/Treatment

Survey of Women PFDs

Women with PFDs

Other: Survey

This is a study to develop a survey for sexual health in women with pelvic floor dysfunction

Outcome Measures

Primary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 100 Years

Sexes Eligible for Study:

Female

Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
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
5	Women's Pelvic Speciality Care PC	Albuquerque	New Mexico	United States	87131
6	Center for Female Sexual Health	Cincinatti	Ohio	United States	45069
7	Cleveland Clinic Lerner College of Medicine	Cleveland	Ohio	United States	44195
8	Genesis Health System	Zanesville	Ohio	United States	52803
9	Geisinger Health Systems	Danville	Pennsylvania	United States	17882
10	Chelsea and Westminster Hospital	London		United Kingdom
11	The Warrell Unit, Whitworth Park	Manchester		United Kingdom
12	Northwick Park and St Marks Hospital	Middlesex		United Kingdom
13	Royal Hallamshire Hospital	Sheffield		United Kingdom
14	Mayday University Hospital	Surrey		United Kingdom