A Multi Center Study to Validate a Condition-specific Measure of Sexual Health in Women With Pelvic Floor Disorders
NCT ID: NCT00952406
Last Updated: 2015-12-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
877 participants
OBSERVATIONAL
2009-08-31
2012-08-31
Brief Summary
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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
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Conditions
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Keywords
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Survey of Women PFDs
Women with PFDs
Survey
This is a study to develop a survey for sexual health in women with pelvic floor dysfunction
Interventions
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Survey
This is a study to develop a survey for sexual health in women with pelvic floor dysfunction
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
100 Years
FEMALE
No
Sponsors
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International Urogynecological Society
OTHER
Responsible Party
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Rebecca G Rogers
Principal Investigator
Principal Investigators
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Rebecca G Rogers, MD
Role: PRINCIPAL_INVESTIGATOR
University of New Mexico Health Sciences Center
Locations
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UCSD women's Pelvic Medicine Center
San Diego, California, United States
Northwestern University Feinburg School of Medicine
Evanston, Illinois, United States
MetroUrology
Minneapolis, Minnesota, United States
University of New Mexico
Albuquerque, New Mexico, United States
Women's Pelvic Speciality Care PC
Albuquerque, New Mexico, United States
Center for Female Sexual Health
Cincinnati, Ohio, United States
Cleveland Clinic Lerner College of Medicine
Cleveland, Ohio, United States
Genesis Health System
Zanesville, Ohio, United States
Geisinger Health Systems
Danville, Pennsylvania, United States
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
Countries
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References
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Rogers RG, Espuna Pons ME. The Pelvic Organ Prolapse Incontinence Sexual Questionnaire, IUGA-revised (PISQ-IR). Int Urogynecol J. 2013 Jul;24(7):1063-4. doi: 10.1007/s00192-012-1952-3. Epub 2013 Apr 30. No abstract available.
Kanter G, Jeppson PC, McGuire BL, Rogers RG. Perineorrhaphy: commonly performed yet poorly understood. A survey of surgeons. Int Urogynecol J. 2015 Dec;26(12):1797-801. doi: 10.1007/s00192-015-2762-1. Epub 2015 Jul 4.
Rockwood TH, Constantine ML, Adegoke O, Rogers RG, McDermott E, Davila GW, Domoney C, Jha S, Kammerer-Doak D, Lukacz ES, Parekh M, Pauls R, Pitkin J, Reid F, Ridgeway B, Thakar R, Sand PK, Sutherland SE, Espuna-Pons M. The PISQ-IR: considerations in scale scoring and development. Int Urogynecol J. 2013 Jul;24(7):1105-22. doi: 10.1007/s00192-012-2037-z. Epub 2013 Apr 30.
Rogers RG, Rockwood TH, Constantine ML, Thakar R, Kammerer-Doak DN, Pauls RN, Parekh M, Ridgeway B, Jha S, Pitkin J, Reid F, Sutherland SE, Lukacz ES, Domoney C, Sand P, Davila GW, Espuna Pons ME. A new measure of sexual function in women with pelvic floor disorders (PFD): the Pelvic Organ Prolapse/Incontinence Sexual Questionnaire, IUGA-Revised (PISQ-IR). Int Urogynecol J. 2013 Jul;24(7):1091-103. doi: 10.1007/s00192-012-2020-8. Epub 2013 Apr 30.
Pauls RN, Rogers RG, Parekh M, Pitkin J, Kammerer-Doak D, Sand P. Sexual function in women with anal incontinence using a new instrument: the PISQ-IR. Int Urogynecol J. 2015 May;26(5):657-63. doi: 10.1007/s00192-014-2563-y. Epub 2014 Nov 13.
Other Identifiers
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IUGA -1 - 09
Identifier Type: -
Identifier Source: org_study_id