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临床试验/NCT00883220
NCT00883220已完成2 期

Self-management of Urine Flow in Long-term Urinary Catheter Users

University of Rochester4 个研究点 分布在 1 个国家目标入组 202 人开始时间: 2009年6月最近更新:
适应症

试验速览

阶段
2 期
状态
已完成
入组人数
202
试验地点
4
主要终点
Symptomatic urinary tract infection

研究概览

简要总结

Learning to self-manage urine flow may help people prevent or minimize persistent complications from long-term indwelling urethral or suprapubic catheters.

详细描述

Urinary catheter users commonly experience adverse health effects, such as urinary tract infection (UTI), blockage, dislodgement, and leakage, leading to poor quality of life indicators. Catheter-related problems often require health care utilization resulting in increased health care costs. Self-management of urine flow is an essential part of self-care for people with long-term urinary catheters and may lead to prevention or reduction of catheter-related problems and improved quality of life.This study tests the effectiveness of a urinary catheter self-management intervention in a randomized trial of 220 patients, with 12 months of follow-up. The experimental intervention is designed to enhance self-management of urine flow in individuals with long-term urinary catheters, with the goal of decreasing catheter related complications and enhancing quality of life.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Single (Investigator)

入排标准

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

入选标准

  • Have an indwelling urethral or suprapubic catheter and expect to use it for at least one year.
  • Live in Central or Western New York State (Utica to Buffalo regions approximately)OR are cared for by the Visiting Nurse Service of New York City.
  • Able to complete study measurements alone or with the help of a family member or caregiver.
  • Able to communicate with the study personnel in English.
  • Have access to a telephone for data collection.

排除标准

  • Terminally ill
  • Cognitively impaired
  • No catheter associated UTI within the previous 12 months NOR blockage NOR dislodgement in the previous 6 months(only in people who have had the catheter for 12 months or more)

结局指标

主要结局

Symptomatic urinary tract infection

时间窗: every two months for 12 months

次要结局

  • Urinary catheter quality of life(6 months and 12 months)

研究者

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

Mary Wilde

Associate Professor

University of Rochester

研究点 (4)

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