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Electronic Urinary Flowmeter to Improve Accuracy of Bladder Diaries .

NCT05702294 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 187

Last updated 2026-02-23

No results posted yet for this study

Summary

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

Conditions

  • Lower Urinary Tract Symptoms
  • Healthy
  • Overactive Bladder (OAB)

Interventions

DEVICE

Diary pod ( measuring vessel that automatically calculates voided volume)

Female study participants with and without Lower Urinary tract Symptoms will be required to void in the measuring cup and write down their estimates on the paper diary and then transfer the voided volume to the diary pod provided (or vice versa).

Sponsors & Collaborators

  • Birmingham Women's and Children's NHS Foundation Trust

    lead OTHER

Principal Investigators

  • Philip Toozs-Hobson, MD · Birmingham Women's NHS Foundation Trust

  • ILIAS LIAPIS, MD · Birmingham Women's and Children's Hospital

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-09-14
Primary Completion
2024-08-06
Completion
2024-08-06

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05702294 on ClinicalTrials.gov