A Prospective Study Looking at Improving Diagnostic Capability of Bladder Diaries by Improving Accuracy of Voided Urine Volume Measured by a Self-administered Measuring Vessel in an Ambulatory Setting in Adult Women With Lower Urinary Tract Symptoms.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 187
- 试验地点
- 1
- 主要终点
- Number of participants with a difference of more than 5% between the estimated recorded voided volumes in milliliters (mL) and the voided volume recorded in milliliters (mL) by the automated device.
研究概览
简要总结
The goal of this clinical trial is to give an answer to the question of whether an automated calculation of voided volumes would produce a more accurate set of bladder diary data when compared to the traditional ''eye-balling'' method of estimated voided volumes of paper bladder diaries, in female adult patients with lower urinary tract symptoms (LUTS).
The main question[s] it aims to answer are:
- Does an automated measurement of voided volumes improve the accuracy of bladder diary data?
- Does an automated measurement of voided volumes improve the utility of bladder diaries?
Participants will be asked to:
- void in the disposable measuring jug and record their estimated voided volume for a total of three consecutive days in a paper diary (as per usual care).
- transfer their voided volume from the disposable jug to the automated vessel (diary pod) after each void for the same three consecutive days.
The reports generated from the paper diaries (estimated volumes) will be compared to the reports generated from the electronic automated measurement of voided volumes to understand whether there is a clinically significant difference between the two.
The investigators aim to recruit healthy female adult volunteers with no lower urinary tract symptoms to understand the normal voiding patterns and volumes of adult females using the diary pod.
The investigators will also recruit adult females with lower urinary tract symptoms and compare the two methods of capturing the voided volume
详细描述
Project Summary:
This study is part of a research project looking at improving accuracy and increasing the utility of bladder diaries, which form one of the most basic first line investigations in females with lower urinary tract symptoms (LUTS). It is a single centre, prospective, interventional study which will offer a vessel for automated measurement of voided volumes of urine. The accuracy of bladder diaries generated by the automated measurement will then be compared to the bladder diaries generated by the conventional eyeballing estimate method of measuring voided volumes.
The principal objective of this study is to give an answer to the question of whether an automated calculation of voided volumes would produce a more accurate set of data that would be inputted in the bladder diary of the patients and therefore improve the utility and diagnostic ability of this gold standard first line investigation.
Study Objectives (Aims):
This project aims to simplify both the collection and analysis; as a result, the test will become simpler to perform, more accurate and helpful to clinicians. It will lead to faster, more accurate assessment of LUTS in women, improving patient satisfaction whilst at the same time providing a cost-effective service.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Eligibility criteria for females with lower urinary tract symptoms:
- •Inclusion Criteria:
- •18 years of age or above
- •Females presenting with lower urinary tract symptoms
排除标准
- •Females who have a mental/physical disability which would make them unable to understand/comply with the requirements of the study.
- •Eligibility criteria for healthy volunteers:
- •Inclusion criteria
- •18 years of age or above
- •Exclusion criteria
- •Females who have a mental/physical disability which would make them unable to understand/comply with the requirements of the study.
- •Female with (LUTS).
研究组 & 干预措施
Intervention group
Adult females with and without lower urinary tract symptoms will complete a 3-day paper bladder diary. After each void they will transfer their voided volume to the diary pod (vessel that calculates automatically the voided volume) for the duration of these three days.
After three days the voided volume estimates of the paper diary versus the recorded voided volumes from the electronic diary pod will be compared.
干预措施: Diary pod ( measuring vessel that automatically calculates voided volume) (Device)
结局指标
主要结局
Number of participants with a difference of more than 5% between the estimated recorded voided volumes in milliliters (mL) and the voided volume recorded in milliliters (mL) by the automated device.
时间窗: After completion of the three day bladder diary ( both paper and electronic version) of all study recruits
The investigators will compare the estimated volumes documented in milliliters (mL) on the paper diary by the participant versus the volumes calculated in milliliters (mL) automatically by the electronic device for each participant. The investigators will calculate the number of participants with a difference greater than 5% between the volumes estimated in their paper bladder diary ( in mL) and the volumes measured ( in mL) automatically by their device . An error of plus or minus 5% of the voided volume in milliliters is the acceptable range as defined by the guidelines of the International Continence Society that provide a benchmark for all urodynamic equipment.
次要结局
未报告次要终点