A Multi Center Study to Validate a Condition-specific Measure of Sexual Health in Women With Pelvic Floor Disorders
Sponsor: International Urogynecological Society
Listed as NCT00952406, this observational or N/A phase trial focuses on Incontinence and Pelvic Floor Disorders and remains completed. Sponsored by International Urogynecological Society, it has been updated 12 times since 2009, reflecting substantial change activity. This study adds to the evidence base for this therapeutic area through structured, versioned documentation.
Study Description(click to expand)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.
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.
Status Flow
Change History
12 versions recorded-
Jan 2026 — Present [monthly]
Completed
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Sep 2025 — Present [monthly]
Completed
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Sep 2024 — Sep 2025 [monthly]
Completed
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Jul 2024 — Sep 2024 [monthly]
Completed
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Dec 2021 — Jul 2024 [monthly]
Completed
▶ Show 7 earlier versions
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Jan 2021 — Dec 2021 [monthly]
Completed
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Nov 2020 — Jan 2021 [monthly]
Completed
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Jun 2018 — Nov 2020 [monthly]
Completed
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May 2018 — Jun 2018 [monthly]
Completed
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Apr 2018 — May 2018 [monthly]
Completed
Phase: NA → None
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Aug 2017 — Apr 2018 [monthly]
Completed NA
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Jan 2017 — Aug 2017 [monthly]
Completed NA
First recorded
Aug 2009
Trial started
Per CT.gov start date — pre-dates our first snapshot
Eligibility Summary
No eligibility information available.
Contact Information
- International Urogynecological Society
For direct contact, visit the study record on ClinicalTrials.gov .