A Multi Center Study to Validate a Condition-specific Measure of Sexual Health in Women With Pelvic Floor Disorders
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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 |
- 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 |
600 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.
Contacts and 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 | |
| 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:
|
Prolapse Pelvic Organ Prolapse Pathological Conditions, Anatomical |
ClinicalTrials.gov processed this record on May 19, 2013