Ignite Creation Date:
2025-12-26 @ 10:58 AM
Ignite Modification Date:
2025-12-29 @ 2:30 PM
Study NCT ID:
NCT00952406
Status:
COMPLETED
Last Update Posted:
2015-12-14
First Post:
2009-08-04
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Multi Center Study to Validate a Condition-specific Measure of Sexual Health in Women With Pelvic Floor Disorders
Sponsor:
International Urogynecological Society
Organization:
Study Overview
Official Title:
A Multi Center Study to Validate a Condition-specific Measure of Sexual Health in Women With Pelvic Floor Disorders
Status:
COMPLETED
Status Verified Date:
2015-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: