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临床试验/NCT00441935
NCT00441935终止不适用

InterStim Prospective Database for Outcomes Research

Kenneth Peters, MD1 个研究点 分布在 1 个国家目标入组 736 人开始时间: 2004年4月最近更新:
适应症

试验速览

阶段
不适用
状态
终止
入组人数
736
试验地点
1

研究概览

简要总结

The study is to collect information from patient charts and patient questionnaires to evaluate the effects of nerve stimulation therapy on urinary dysfunction.

详细描述

Men and women with urinary incontinence (leakage of urine), frequency, and bladder pain experience embarrassment, inconvenience, and a significant negative impact on their quality of life. Although traditional treatments such as medications, diet modification, and bladder training provide relief for some people, others do not experience improvement with these treatments. Recently, mechanical devices much like a heart pacemaker have been developed to stimulate the nerves (sacral and pudendal) responsible for controlling bladder function. During a two stage operation, a permanent electrical wire is implanted in the lower back and connected to a mechanical box (stimulator) implanted under the patients skin in the hip area.

Participants will be asked to complete a set of questionnaires (Intake Form, Urinary Incontinence Treatment Network (UITN) Sexual Activity Questionnaire, Interstitial Cystitis Symptom Index and Problem Index, voiding diary) within 60 days prior to the procedure. Preoperative clinical information such as primary diagnosis, history of failed therapies, and medical history will be collected from the physician office record, and operative information will be collected from the inpatient hospital record. After the two stage operation (3, 6, and 12 months, then yearly thereafter as long as the device is in place) participants will be sent questionnaires. Upon completion and return to the study site

研究设计

研究类型
Observational
观察模型
Other
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •All patients at least 18 years of age scheduled for sacral nerve stimulator implantation at William Beaumont Hospital, Royal Oak, Michigan who give informed consent to participate in the project.

排除标准

  • 未提供

研究者

申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Kenneth Peters, MD

Principal Investigator

William Beaumont Hospitals

研究点 (1)

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