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临床试验/NCT03263676
NCT03263676已完成不适用

Randomized Controlled Crossover Comparison of Icon Underwear to Disposable Pads

Medstar Health Research Institute0 个研究点目标入组 70 人开始时间: 2016年7月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
70
主要终点
Incontinence Quality of Life Questionnaire

研究概览

简要总结

This is a randomized cross over trial to compare quality of life and product performance between Icon reusable underwear versus standard disposable pad in patients with mild to moderate urinary incontinence.

详细描述

Urinary incontinence is estimated to affect approximately 1/5 of all women in the United States. Multiple studies have compared effectiveness, cost-effectiveness and comfort of a variety absorbent products but most of the current data compares daily disposable insert pads. Icon reusable underwear is a new product on the market for light incontinence (25-30mL daily). The primary objective of this randomized cross over trial is to compare quality of life and patient comfort and to determine patient preference using Icon reusable underwear versus standard incontinence pad in the management of urinary incontinence. The secondary objective is to compare the cost-effectiveness of ICON underwear to disposable pads. Women with small to moderate urinary incontinence to use either ICON underwear or pads for two days and then crossed over to use other product for two days. The primary outcome measures were Incontinence Quality of Life Instrument 3 (I-QOL) and Product Performance Questionnaire 4 (PPQ) after use of each product. A sample size of 70 was calculated to detect a difference of 10.0 in the I-QOL to achieve a power of 80% with a significance level of 0.05 and to account for a 20% attrition.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Supportive Care
盲法
None

入排标准

性别
Female
接受健康志愿者

入选标准

  • Female patients who are at least 18yo
  • Mild to moderate urinary incontinence, defined as a response "small" or "moderate" amount to the ICIQ-SF question - "How much do you leak?"

排除标准

  • Active urinary tract infection
  • Fecal incontinence, defined as a response "large" amount to the ICIQ-SF question - "How much do you leak?"

研究组 & 干预措施

Icon reusable underwear

Experimental

干预措施: Disposable pad (Device)

Disposable pad

Placebo Comparator

干预措施: Icon resuable underwear (Device)

结局指标

主要结局

Incontinence Quality of Life Questionnaire

时间窗: 2 days

Validated quality of life questionnaire

次要结局

  • Product Performance Questionnaire(2 days)

研究者

发起方
Medstar Health Research Institute
申办方类型
Other
责任方
Sponsor

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