A Multi Center Study to Validate a Condition-specific Measure of Sexual Health in Women With Pelvic Floor Disorders
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 877
- 试验地点
- 14
- 主要终点
- 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.
研究概览
简要总结
Study Aims:
- To validate a new measure of sexual function and activity in women with PFDs;
- 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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •Women under the age of
- •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.
结局指标
主要结局
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.
时间窗: 3-5 months
次要结局
未报告次要终点
研究者
Rebecca G Rogers
Principal Investigator
International Urogynecological Society