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.

Completed

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Key information

Conditions

Pelvic Floor Disorders Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Incontinence Male Urogenital Diseases Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Pelvic Organ Prolapse Pregnancy Complications Prolapse Sexual Dysfunction Sexual Dysfunction, Physiological Urogenital Diseases

Age range

18 year–100 year

Sex eligibility

Female

Study type

Observational

Primary location

Chelsea and Westminster Hospital, London, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Survey

Other

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

Primary outcomes

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

Sponsors and collaborators

Lead sponsor

International Urogynecological Society

Other

Registry information

Important dates

Study start: 2009
Primary completion: 2012
Study completion: 2012
First posted: Aug 6, 2009
Registry last updated: Dec 14, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed