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

Sponsor:	International Urogynecological Society
Information provided by (Responsible Party):	Rebecca G Rogers, International Urogynecological Society
ClinicalTrials.gov Identifier:	NCT00952406

Purpose

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
Pelvic Floor Disorders Sexual Function Incontinence Pelvic Organ Prolapse

Study Type:	Observational
Study Design:	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

Resource links provided by NLM:

MedlinePlus related topics: Pelvic Support Problems Urinary Incontinence

U.S. FDA Resources

Further study details as provided by International Urogynecological Society:

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. [ Time Frame: 3-5 months ] [ Designated as safety issue: No ]

Biospecimen Retention: None Retained

No Biospecimens are to be retained.

Estimated Enrollment:	600
Study Start Date:	August 2009
Estimated Study Completion Date:	June 2012
Estimated Primary Completion Date:	June 2012 (Final data collection date for primary outcome measure)

Groups/Cohorts
Women with urinary and/or anal incontinence and/or POP Women with PFDs

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

600 women with pelvic floor disorders presenting for urogynecological care in the United States or England

Criteria

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00952406

Locations

United States, California
UCSD women's Pelvic Medicine Center
San Diego, California, United States, 92037
United States, Illinois
Northwestern University Feinburg School of Medicine
Evanston, Illinois, United States
United States, Minnesota
MetroUrology
Minneapolis, Minnesota, United States, 55441
United States, New Mexico
University of New Mexico
Albuquerque, New Mexico, United States, 87131
Women's Pelvic Speciality Care PC
Albuquerque, New Mexico, United States, 87131
United States, Ohio
Center for Female Sexual Health
Cincinatti, Ohio, United States
Cleveland Clinic Lerner College of Medicine
Cleveland, Ohio, United States
Genesis Health System
Zanesville, Ohio, United States
United States, Pennsylvania
Geisinger Health Systems
Danville, Pennsylvania, United States
United Kingdom
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

Sponsors and Collaborators

International Urogynecological Society

Investigators

Principal Investigator:

Rebecca G Rogers, MD

University of New Mexico Health Sciences Center

More Information

No publications provided

Responsible Party:	Rebecca G Rogers, Principal Investigator, International Urogynecological Society
ClinicalTrials.gov Identifier:	NCT00952406 History of Changes
Other Study ID Numbers:	IUGA -1 - 09
Study First Received:	August 4, 2009
Last Updated:	November 15, 2011
Health Authority:	United States: Institutional Review Board

Keywords provided by International Urogynecological Society:

Pelvic Floor Disorders
Sexual Function
Incontinence
Pelvic Organ Prolapse

Additional relevant MeSH terms:

Urinary Incontinence
Prolapse
Pelvic Organ Prolapse
Urination Disorders

Urologic Diseases
Urological Manifestations
Signs and Symptoms
Pathological Conditions, Anatomical

ClinicalTrials.gov processed this record on February 09, 2012