Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Study Aims:
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.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Survey of Women PFDs | Women with PFDs |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Survey | Other | This is a study to develop a survey for sexual health in women with pelvic floor dysfunction |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
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
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Rebecca G Rogers, MD | University of New Mexico Health Sciences Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UCSD women's Pelvic Medicine Center | San Diego | California | 92037 | United States | ||
| Northwestern University Feinburg School of Medicine |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23632797 | Background | 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. | |
| 26142348 | Result | 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. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
No Biospecimens are to be retained.
| 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 |
| 23632799 | Result | 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. |
| 23632798 | Result | 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. |
| 25392184 | Result | 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. |
| ID | Term |
|---|---|
| D059952 | Pelvic Floor Disorders |
| D012735 | Sexual Dysfunction, Physiological |
| D056887 | Pelvic Organ Prolapse |
| ID | Term |
|---|---|
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D011248 | Pregnancy Complications |
| D052801 | Male Urogenital Diseases |
| D000091662 | Genital Diseases |
| D011391 | Prolapse |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| D011795 | Surveys and Questionnaires |
| ID | Term |
|---|---|
| D003625 | Data Collection |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D017531 | Health Care Evaluation Mechanisms |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D011634 | Public Health |
| D004778 | Environment and Public Health |
Not provided
Not provided