跳至主要内容
临床试验/NCT07269652
NCT07269652已完成不适用

HappyOrNot® Smileys and the Visual Analogue Scale (VAS) in the Assessment of Urinary Symptoms

Seinajoki Central Hospital2 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2022年8月1日最近更新:

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
100
试验地点
2
主要终点
HappyorNot smileys and Visual Analogue Scale in the assesment of urinary symptoms

研究概览

简要总结

INTRODUCTION A simple and repeatable test would be valuable for assessing the severity and impact of urinary symptoms. Visual Analogue Scale (VAS) is a 10 cm line where a participant put a mark in place that describes best his satisfaction with woiding. VAS has been shown to correlate with flowmetry and International Prostate Symptom Score (IPSS). VAS is still a number and may not reflect participants satisfaction. HappyorNot smileys (HoN) (emoji faces) are used to measure customer satisfaction by pressing one of four emoji smilyes. Two of these are happy and two and unhappy.

OBJECTIVE:

- To study the use of VAS and HoN in assessing urinary symptoms in men.

MATERIALS AND METHODS:

  • 100 men referred to urology outpatient clinic in Tampere University Hospital or Seinäjoki Central Hospital due to urinary symptoms caused by benign Prostate Hyperplasia (BPH)
  • Participants are asked to fill VAS and HoN and results are correlated with traditional symptom questionnaires and peak urinary flow and post-void residual volume.

详细描述

Introduction

Several validated questionnaires have been developed to assess the severity and impact of urinary symptoms, using different sets of questions and scoring methods. Although these tests can provide an accurate assessment of patients' symptoms and the bother caused by them, their clinical usability is limited. Some patients have difficulty completing and understanding the questionnaires without assistance. In addition, analysing multi-item questionnaires based on numerical values is time-consuming, and their repeatability in clinical practice is questionable.

A simple, easy-to-use, and easily repeatable test would be valuable for assessing the severity and impact of urinary symptoms. One possibility is the Visual Analogue Scale (VAS), where the patient evaluates symptom severity or bother on a 10-cm line, with one end representing no symptoms/no bother and the other end representing the worst possible symptom/bother.

VAS scales have been used successfully for many years, particularly in pain assessment. For example, in urogynecological conditions, VAS has been shown to be a functional and reproducible tool compared with validated questionnaires. However, some negative findings have also been reported regarding its use in assessing urinary incontinence in women.

The use of VAS for evaluating lower urinary tract symptoms in men has been studied. The study compared VAS with the seven symptoms assessed by the IPSS questionnaire and found a good correlation. VAS compared with IPSS has also been studied in prostate cancer patients undergoing radiation therapy, where VAS performed even better than IPSS in measuring quality of life. The clinical validation of VAS for urinary symptoms has been reported in one study of 1,000 men, showing good correlation with both IPSS and uroflowmetry. In our own pilot study, VAS correlated well with the EPIC-26 questionnaire when assessing post-prostatectomy urinary symptoms.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Diagnostic
盲法
None

入排标准

性别
Male
接受健康志愿者

入选标准

  • all men having urinary symptoms due to prostate hyperplasia

排除标准

  • not signing informed consent

结局指标

主要结局

HappyorNot smileys and Visual Analogue Scale in the assesment of urinary symptoms

时间窗: From enrollment to the end of outpatient clinic visit

HappyOrNot® smileys (four faces of which two represent different degrees of happyness and two different degree of unhappyness) and the Visual Analog Scale (0-10 cm, 0 cm meaning total unsatisfaction and 10 cm meanning total satisfaction) assessing urinary symptoms in men referred to the urology outpatient clinic, using traditional questionnaire as the reference. In addition, to investigate the association between HappyOrNot®/VAS results and objective measures of urinary symptom severity, such as peak urinary flow and post-void residual volume.

次要结局

未报告次要终点

研究者

发起方
Seinajoki Central Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Mika Raitanen

M.D., Ph.D, Associate Professor

Tampere University

研究点 (2)

Loading locations...

相似试验