Observing Pelvic Organ Prolapse Symptoms And Treatment Outcomes
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 301
- 试验地点
- 1
- 主要终点
- Changes in urinary, bowel, and sexual function as measured on the PFDI, PFIQ, and PISQ validated questionnaires
研究概览
简要总结
To prospectively observe the outcomes of surgical prolapse treatment in terms of urinary, bowel, and sexual function, quality of life, patient satisfaction, cost, and achieving patient determined treatment goals.
详细描述
Patients meeting the inclusion/exclusion criteria will be identified by reviewing the hospital's surgical boarding list and contacted by phone to obtain informed consent. Once informed consent is obtained, chart review will be conducted here at William Beaumont Hospital and at the physician's office to collect patient information related to their prolapse condition. Prior to surgery, questionnaires will be mailed and completed by the participant and then again at 6 and 12 months after surgery, and then yearly. Questionnaires will assess urinary, bowel, and sexual function, and patient treatment goals, treatment satisfaction, and general health and wellbeing. Completion of the questionnaires will be voluntary, and participants will be followed in this manner until voluntary withdrawal, exclusionary criteria emerge, or death.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Other
入排标准
- 年龄范围
- 21 Years 至 —(Adult, Older Adult)
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Pelvic Organ Prolapse
- •Able to provide informed consent
- •Able to complete study assessments, per clinician judgment
排除标准
- •Age < 21 years
- •Currently pregnant or < 6 months post-partum
结局指标
主要结局
Changes in urinary, bowel, and sexual function as measured on the PFDI, PFIQ, and PISQ validated questionnaires
时间窗: Ongoing
次要结局
未报告次要终点
研究者
Melissa Fischer, MD
Principal Investigator
William Beaumont Hospitals
