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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Rebecca G Rogers, International Urogynecological Society
ClinicalTrials.gov Identifier:
NCT00952406
First received: August 4, 2009
Last updated: December 10, 2015
Last verified: December 2015

August 4, 2009
December 10, 2015
August 2009
August 2012   (final data collection date for primary outcome 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. [ Time Frame: 3-5 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00952406 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
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A Multi Center Study to Validate a Condition-specific Measure of Sexual Health in Women With Pelvic Floor Disorders
A Multi Center Study to Validate a Condition-specific Measure of Sexual Health in Women With Pelvic Floor Disorders

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.

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.
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Retention:   None Retained
Description:
No Biospecimens are to be retained.
Non-Probability Sample
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
  • Pelvic Floor Disorders
  • Sexual Dysfunction
  • Incontinence
  • Pelvic Organ Prolapse
Other: Survey
This is a study to develop a survey for sexual health in women with pelvic floor dysfunction
Survey of Women PFDs
Women with PFDs
Intervention: Other: Survey

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
877
August 2012
August 2012   (final data collection date for primary outcome measure)

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.
Female
18 Years to 100 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States,   United Kingdom
 
NCT00952406
IUGA -1 - 09
No
Not Provided
Not Provided
Rebecca G Rogers, International Urogynecological Society
International Urogynecological Society
Not Provided
Principal Investigator: Rebecca G Rogers, MD University of New Mexico Health Sciences Center
International Urogynecological Society
December 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP