A Multi Center Study to Validate a Condition-specific Measure of Sexual Health in Women With Pelvic Floor Disorders - NCT00952406-87131B (Clinical Trial 304746)
Permalink: http://www.ClinicalConnection.com/exp/ExpandedPatientViewStudy304746.aspx
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| City: |
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Albuquerque |
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State:
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NM |
| Zip Code: |
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87131 |
| Conditions: |
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Pelvic Floor Disorders - Sexual Function - Incontinence - Pelvic Organ Prolapse |
| Purpose: |
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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.
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| Study summary: |
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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. |
| Criteria: |
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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. |
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| Study is available at: |
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Women's Pelvic Speciality Care PC
Albuquerque, NM 87131
United States
Primary Contact:
Rebecca G Rogers, MD
Email: rrogers@salud.unm.edu
Phone: 505-272-9712 |
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If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
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| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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March 16, 2010 |
Modifications to
this listing: |
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Only selected fields are shown, please use the link
above to view all information about this clinical trial. |
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Clinical trials are medical research studies designed to test the safety and/or
effectiveness of new drugs, devices, or treatments in humans. These studies are
conducted worldwide for a range of conditions and illnesses. Learn more about
clinical research and participating in a study at
About Clinical Trials.
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