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

December 10, 2015 updated by: Rebecca G Rogers, International Urogynecological Society

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

877

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • London, United Kingdom
        • Chelsea and Westminster Hospital
      • Manchester, United Kingdom
        • The Warrell Unit, Whitworth Park
      • Middlesex, United Kingdom
        • Northwick Park and St Marks Hospital
      • Sheffield, United Kingdom
        • Royal Hallamshire Hospital
      • Surrey, United Kingdom
        • Mayday University Hospital
  • United States
    • California
      • San Diego, California, United States, 92037
        • UCSD Women's Pelvic Medicine Center
    • Illinois
      • Evanston, Illinois, United States, 60611
        • Northwestern University Feinburg School of Medicine
    • Minnesota
      • Minneapolis, Minnesota, United States, 55441
        • MetroUrology
    • New Mexico
      • Albuquerque, New Mexico, United States, 87131
        • University of New Mexico
      • Albuquerque, New Mexico, United States, 87131
        • Women's Pelvic Speciality Care PC
    • Ohio
      • Cincinatti, Ohio, United States, 45069
        • Center for Female Sexual Health
      • Cleveland, Ohio, United States, 44195
        • Cleveland Clinic Lerner College of Medicine
      • Zanesville, Ohio, United States, 52803
        • Genesis Health System
    • Pennsylvania
      • Danville, Pennsylvania, United States, 17882
        • Geisinger Health Systems

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 100 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

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

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Survey of Women PFDs
Women with PFDs
Other: Survey
This is a study to develop a survey for sexual health in women with pelvic floor dysfunction

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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.
Time Frame: 3-5 months
3-5 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

International Urogynecological Society

Investigators

  • Principal Investigator: Rebecca G Rogers, MD, University of New Mexico Health Sciences Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2009

Primary Completion (Actual)

August 1, 2012

Study Completion (Actual)

August 1, 2012

Study Registration Dates

First Submitted

August 4, 2009

First Submitted That Met QC Criteria

August 5, 2009

First Posted (Estimate)

August 6, 2009

Study Record Updates

Last Update Posted (Estimate)

December 14, 2015

Last Update Submitted That Met QC Criteria

December 10, 2015

Last Verified

December 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IUGA -1 - 09

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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