跳至主要内容
临床试验/NCT00784602
NCT00784602终止不适用

Observing Pelvic Organ Prolapse Symptoms And Treatment Outcomes

Melissa Fischer, MD1 个研究点 分布在 1 个国家目标入组 301 人开始时间: 2008年10月29日最近更新:
适应症

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

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

发起方
Melissa Fischer, MD
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Melissa Fischer, MD

Principal Investigator

William Beaumont Hospitals

研究点 (1)

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