跳至主要内容
临床试验/CTRI/2025/08/092652
CTRI/2025/08/092652招募中不适用

A single centre, Prospective, observational study to evaluate the effectiveness of electronic versus paper-based bladder diaries in the clinical assessment of lower urinary tract symptoms.

Bhaktivedanta Hospital and Research Institute1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2025年8月19日最近更新:

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
100
试验地点
1
主要终点
The study will be to determine whether electronic bladder diaries improve user compliance, data completeness, and clinical utility compared to traditional paper-based diaries in the assessment of lower urinary tract symptoms.

研究概览

简要总结

This study aims to compare electronic bladder diaries (EBD) and paper bladder diaries (PBD) in assessing lower urinary tract symptoms (LUTS). The primary objective is to evaluate the feasibility, user compliance, data completeness, and overall satisfaction of EBDs versus PBDs. Secondary objectives include comparing data accuracy, clinician ease-of-use, and patient preference between the two formats. This single-center, prospective, observational study will enroll participants aged 18 or older, with documented LUTS, who can use a smartphone and read/write in the study language. Over a period of four days, participants will complete both EBD and PBD, and data on voiding patterns, fluid intake, urgency, incontinence, and nocturia will be collected. The study will measure compliance, data quality, and user satisfaction to determine if EBD offers superior benefits in clinical utility compared to traditional PBDs

研究设计

研究类型
Observational

入排标准

年龄范围
18.00 Year(s) 至 80.00 Year(s)(—)
性别
All

入选标准

  • 1.Age more than or equal to 18 years with documented LUTS.
  • 2.Owns and can operate a smartphone (for EBD arm).
  • 3.Able to read/write in the study language.
  • 4.Giving consent to participate in the study.

排除标准

  • 1.Cognitive impairment prevents diary use.
  • 2.Inability to use mobile devices (if assigned to EBD).
  • 3.Illiteracy (if assigned to PBD only).
  • 4.Not giving consent to participate in the study.

结局指标

主要结局

The study will be to determine whether electronic bladder diaries improve user compliance, data completeness, and clinical utility compared to traditional paper-based diaries in the assessment of lower urinary tract symptoms.

时间窗: At Day 02, Day 04 and Day 05

次要结局

  • 1. Proportion of fully completed diary fields per day.(2. Number of missing or inconsistent entries in each diary format to evaluate data quality.)

研究者

发起方
Bhaktivedanta Hospital and Research Institute
申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

Dr AjayKumar Gajengi

Bhaktivedanta Hospital and Research Institute

研究点 (1)

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