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临床试验/NCT01063452
NCT01063452撤回4 期

Impact of Atkinson Product Design Urinary Slide Valve Versus Standard Catheter Drainage System on Social Functioning

The Cleveland Clinic2 个研究点 分布在 1 个国家开始时间: 2010年2月1日最近更新:
适应症
干预措施

试验速览

阶段
4 期
状态
撤回
试验地点
2
主要终点
The primary objective of this study is to evaluate the impact of the Atkinson Product Design urinary slide valve on patient morbidity and freedom as measured by impact on activities of daily living (ADL) and quality of life (QOL).

研究概览

简要总结

The primary objective of this study is to evaluate the impact of the Atkinson Product Design urinary slide valve on patient morbidity and freedom as measured by impact on activities of daily living (ADL) and quality of life (QOL). Secondary objectives include assessing the impact of the device on bacteruria and evaluating the impact of the primary treatment on ADL and QOL.

详细描述

Several indications exist in urologic practice where urinary drainage via a urethral catheter is required and an estimated 4 million patients in the United States undergo urinary catheterization per year.(1) Though it is common for urine to be continually collected in a bag attached to the catheter by plastic tubing, catheter valves offer an alternative method of storing and voiding urine. Catheter valves are small devices that fit into the external end of the urethral catheter. Rather than continuous drainage, urine is stored in the bladder and emptied on regular intervals by opening the valve.

This method of drainage may offer several benefits including preserving bladder capacity, function and tone, reducing catheter blockage in cases of urine bacterial colonization, and decreasing traction forces on the bladder neck by removing the downward weight of a collecting bag.(2-4) The use of a catheter valve may offer improvements in social functioning and mobility.(5) Studies to date suggest that catheter valves are well tolerated by patients, but these studies have used non-standardized questionnaires and have not assessed overall quality of life.(5, 6) Additionally, there may be an associated cost benefit to utilizing catheter valves compared to drainage bags.(5)

Further study in this area, focusing on quality of life and social functioning, will enable the clinician to better counsel patients on the risks and benefits of the various methods of urinary drainage.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
盲法
None

入排标准

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

入选标准

  • •Patients undergoing brachytherapy or cryotherapy for prostate cancer
  • •Patients undergoing thermal therapy for benign prostatic hyperplasia
  • •Patients undergoing catheterization to relieve urinary retention

排除标准

  • •Patients with neurogenic bladder
  • •Patients with urinary tract infection
  • •Patients with gross hematuria
  • •Patients undergoing surgery with risk of urinary leak (ex: urethroplasty, radical prostatectomy, bladder repair)
  • •Female patients

研究组 & 干预措施

Truvalve

Experimental

Atkinson Product Design urinary slide valve on the catheter

干预措施: Truvalve (Device)

Control

Active Comparator

Drainage bag on the catheter

干预措施: Control (catheter drainage bag) (Other)

结局指标

主要结局

The primary objective of this study is to evaluate the impact of the Atkinson Product Design urinary slide valve on patient morbidity and freedom as measured by impact on activities of daily living (ADL) and quality of life (QOL).

时间窗: 1 month after catheter removal

次要结局

  • Secondary objectives include assessing the impact of the device on bacteruria and evaluating the impact of the primary treatment on ADL and QOL.(At time of catheter removal)

研究者

申办方类型
Other

研究点 (2)

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