Clinical trial NCT00952406: A Multi Center Study to Validate a Condition-specific Measure of Sexual Health in Women With Pelvic Floor Disorders
Official title: A Multi Center Study to Validate a Condition-specific Measure of Sexual Health in Women With Pelvic Floor Disorders
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pelvic Floor Disorders
Sexual Dysfunction
Incontinence
Pelvic Organ Prolapse
Keywords: Pelvic Floor Disorders
Sexual Function
Incontinence
Pelvic Organ Prolapse
Lead sponsor: International Urogynecological Society
Sponsor class: OTHER
First posted: 2009-08-06
Enrollment: 877
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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

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.

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.

Eligibility criteria: Inclusion Criteria:

* Inclusion criteria for patients include age over 18 years.
* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: 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.
timeFrame: 3-5 months
Secondary outcomes:
Other outcomes:
Locations:
city: San Diego
country: United States
facility: UCSD women's Pelvic Medicine Center
state: California
city: Evanston
country: United States
facility: Northwestern University Feinburg School of Medicine
state: Illinois
city: Minneapolis
country: United States
facility: MetroUrology
state: Minnesota
city: Albuquerque
country: United States
facility: University of New Mexico
state: New Mexico
city: Albuquerque
country: United States
facility: Women's Pelvic Speciality Care PC
state: New Mexico
city: Cincinatti
country: United States
facility: Center for Female Sexual Health
state: Ohio
city: Cleveland
country: United States
facility: Cleveland Clinic Lerner College of Medicine
state: Ohio
city: Zanesville
country: United States
facility: Genesis Health System
state: Ohio
city: Danville
country: United States
facility: Geisinger Health Systems
state: Pennsylvania
city: London
country: United Kingdom
facility: Chelsea and Westminster Hospital
city: Manchester
country: United Kingdom
facility: The Warrell Unit, Whitworth Park
city: Middlesex
country: United Kingdom
facility: Northwick Park and St Marks Hospital
city: Sheffield
country: United Kingdom
facility: Royal Hallamshire Hospital
city: Surrey
country: United Kingdom
facility: Mayday University Hospital
Study officials:
affiliation: University of New Mexico Health Sciences Center
name: Rebecca G Rogers, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.