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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00952406
Recruitment Status : Completed
First Posted : August 6, 2009
Last Update Posted : December 14, 2015
Information provided by (Responsible Party):
Rebecca G Rogers, 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.

Condition or disease Intervention/treatment
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 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 : August 2009
Actual Primary Completion Date : August 2012
Actual Study Completion Date : August 2012

Resource links provided by the National Library of Medicine

Group/Cohort 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

Primary Outcome Measures :
  1. 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 ]

Biospecimen Retention:   None Retained
No Biospecimens are to be retained.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Goal to enroll approximately 800 women so that 600 surveys are available for evaluation of the sexual health of women with pelvic floor disorders presenting for urogynecological care in the United States or England

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00952406

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, 60611
United States, Minnesota
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, 45069
Cleveland Clinic Lerner College of Medicine
Cleveland, Ohio, United States, 44195
Genesis Health System
Zanesville, Ohio, United States, 52803
United States, Pennsylvania
Geisinger Health Systems
Danville, Pennsylvania, United States, 17882
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
Principal Investigator: Rebecca G Rogers, MD University of New Mexico Health Sciences Center

Publications of Results:
Other Publications:
Responsible Party: Rebecca G Rogers, Principal Investigator, International Urogynecological Society Identifier: NCT00952406     History of Changes
Other Study ID Numbers: IUGA -1 - 09
First Posted: August 6, 2009    Key Record Dates
Last Update Posted: December 14, 2015
Last Verified: December 2015

Keywords provided by Rebecca G Rogers, International Urogynecological Society:
Pelvic Floor Disorders
Sexual Function
Pelvic Organ Prolapse

Additional relevant MeSH terms:
Pelvic Organ Prolapse
Pelvic Floor Disorders
Pathologic Processes
Pathological Conditions, Anatomical
Pregnancy Complications