A Multi Center Study to Validate a Condition-specific Measure of Sexual Health in Women With Pelvic Floor Disorders

Pelvic Organ Prolapse Clinical Trial

Official title:

A Multi Center Study to Validate a Condition-specific Measure of Sexual Health in Women With Pelvic Floor Disorders

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00952406
• Other study ID #: IUGA -1 - 09
• Status: Completed
• Phase: N/A
• First received: August 4, 2009
• Last updated: December 10, 2015
• Start date: August 2009
• Est. completion date: August 2012

Study information

• Verified date: December 2015
• Source: International Urogynecological Society
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 877
• Est. completion date: August 2012
• Est. primary completion date: August 2012
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 100 Years

Eligibility

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.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Incontinence
• Pelvic Floor Disorders
• Pelvic Organ Prolapse
• Prolapse
• Sexual Dysfunction

Intervention

Other:
• Survey
This is a study to develop a survey for sexual health in women with pelvic floor dysfunction

Locations

Country	Name	City	State
United Kingdom	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 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	Cincinatti	Ohio
United States	Cleveland Clinic Lerner College of Medicine	Cleveland	Ohio
United States	Geisinger Health Systems	Danville	Pennsylvania
United States	Northwestern University Feinburg School of Medicine	Evanston	Illinois
United States	MetroUrology	Minneapolis	Minnesota
United States	UCSD women's Pelvic Medicine Center	San Diego	California
United States	Genesis Health System	Zanesville	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
International Urogynecological Society

Countries where clinical trial is conducted

United States,  United Kingdom, 

References & Publications (5)

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. — View 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. — View 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 — View Citation

Rogers RG, Espuña 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. — View 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 floo — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No