A Multi Center Study to Validate a Condition-specific Measure of Sexual Health in Women With Pelvic Floor Disorders
1 other identifier
observational
877
2 countries
14
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Aug 2009
Typical duration for all trials
14 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2009
CompletedFirst Submitted
Initial submission to the registry
August 4, 2009
CompletedFirst Posted
Study publicly available on registry
August 6, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2012
CompletedDecember 14, 2015
December 1, 2015
3 years
August 4, 2009
December 10, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
3-5 months
Study Arms (1)
Survey of Women PFDs
Women with PFDs
Interventions
This is a study to develop a survey for sexual health in women with pelvic floor dysfunction
Eligibility Criteria
Goal to enroll approximately 800 women so that 600 surveys are available for evaluation of the sexual health of women with pelvic floor disorders presenting for urogynecological care in the United States or England
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (14)
UCSD women's Pelvic Medicine Center
San Diego, California, 92037, United States
Northwestern University Feinburg School of Medicine
Evanston, Illinois, 60611, United States
MetroUrology
Minneapolis, Minnesota, 55441, United States
University of New Mexico
Albuquerque, New Mexico, 87131, United States
Women's Pelvic Speciality Care PC
Albuquerque, New Mexico, 87131, United States
Center for Female Sexual Health
Cincinnati, Ohio, 45069, United States
Cleveland Clinic Lerner College of Medicine
Cleveland, Ohio, 44195, United States
Genesis Health System
Zanesville, Ohio, 52803, United States
Geisinger Health Systems
Danville, Pennsylvania, 17882, 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
Related Publications (5)
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.
PMID: 23632797BACKGROUNDKanter 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.
PMID: 26142348RESULTRockwood 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.
PMID: 23632799RESULTRogers 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.
PMID: 23632798RESULTPauls 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.
PMID: 25392184RESULT
Biospecimen
No Biospecimens are to be retained.
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Rebecca G Rogers, MD
University of New Mexico Health Sciences Center
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
August 4, 2009
First Posted
August 6, 2009
Study Start
August 1, 2009
Primary Completion
August 1, 2012
Study Completion
August 1, 2012
Last Updated
December 14, 2015
Record last verified: 2015-12