Electronic Urinary Flowmeter to Improve Accuracy of Bladder Diaries .

NCT ID: NCT05702294

Last Updated: 2023-01-27

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-09-14
• Study Completion Date: 2025-07-19

Brief 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

Detailed Description

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.

Null hypothesis:

Automated measurement of voided volumes and improved accuracy of bladder diary data does not affect utility of bladder diaries.

Primary outcome of study:

Accuracy of measurement of voided volume with automated device (aim to be within 3%) as defined international standard.

Secondary outcome of study:

1. Outline existing evidence and identify gaps in the knowledge

2. Outline areas of future development

3. Educational purposes as it is a student research project

Methods and materials:

i. Study Design: This is a prospective, monocentric, open label, non-randomised, observational study in which the investigators aim to demonstrate error in "eye ball" (traditional method of estimating voided volumes) and increased accuracy of the automated vessel to within the internationally recognized standard of 3% using a flowmeter as the gold standard.

The investigators will achieve that by:

A. Perform Bench testing. In vitro assessment to demonstrate error in "eye-ball" (traditional method of estimating voided volumes) and increased accuracy to within the internationally recognized standard of 3% using a flowmeter as the gold standard.

B. Recruiting a control group (healthy individual adult women with no lower urinary tract symptoms) to develop more accurate nomograms of bladder function. This will require between 25-50 women of various ages. The control group will be blinded to the automatic cup measurements.

C. Using the tool with women presenting to the Urogynaecology service using the conventional "eye-balling " method and automated uroflowmetry system to assess error from eye-balling and assess how the bladder diary changes comparing the two methods. The investigators would like to recruit approximately 50 patients in each of the following groups: overactive bladder, stress incontinence and prolapse. The groups will be compared using a T test as data are normally distributed. The new nomograms will use ANOVA software and replicate the statistics already established for this. The participants in those groups will be also blinded to the automatic cup measurements generated.

D. Developing Receiver Operating characteristic (ROC) curves for potential diagnostic accuracy tests correlated with increased specificity of voided volumes for future studies.

This study design has been chosen in order to demonstrate the potential diagnostic benefits of a diary generated by an automated voiding measurement system.

Participants will be female adults who present in Urogynaecology clinics with lower urinary tract symptoms and require a bladder diary as a first line investigation tool.

Recruitment will take place in the Outpatient Urogynaecology clinic. Women presenting with lower urinary tract symptoms will be identified by the Urogynaecology team in clinic and asked to complete a 3-day paper bladder diary by voiding into the disposable paper jug (as per their usual care). For each void over the 3-day period they will be asked to transfer the voided volume from the disposable paper jug to the diary pod (automated device) which will automatically calculate the voided volume and store the result automatically to the app on their phone. The patient might choose to void first in the automated diary pod and then transfer the voided volume to the conventional paper jag. Both ways are acceptable. The participants will be blinded to those automated measurements as they will not be able to see the volume recorded on the app. All these volumes will be stored in an online electronic portal. The only person with access to the patient's portal is the clinician responsible for the research project. At the end of the 3-day period the portal will generate an automated electronic summary of the 3 day diary and this will be compared to the paper diary. The device does not require calibration as it is already pre-calibrated. A patient information leaflet will be handed out to the participants and the risks/benefits and rights to voluntarily participate and withdraw from their study explained. Informed consent will be taken in an outpatient clinic setting after the patient has read the patient information leaflet.

Conditions

Lower Urinary Tract Symptoms; Healthy

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Control

Adult females with no 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 reports of the paper diary versus the electronic diary will be compared.

Group Type: EXPERIMENTAL

Diary pod ( measuring vessel that automatically calculates voided volume)

Intervention Type: DEVICE

Women in the control arm of the study 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).

LUTS ( Lower urinary tract symptoms) arm

Adult females with 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 reports of the paper diary versus the electronic diary will be compared.

Group Type: EXPERIMENTAL

Diary pod ( measuring vessel that automatically calculates voided volume)

Intervention Type: DEVICE

Women in the Lower Urinary Tract Symptoms ( LUTS) arm of the study 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).

Interventions

Diary pod ( measuring vessel that automatically calculates voided volume)

Women in the control arm of the study 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).

Intervention Type: DEVICE

Diary pod ( measuring vessel that automatically calculates voided volume)

Women in the Lower Urinary Tract Symptoms ( LUTS) arm of the study 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).

Intervention Type: DEVICE

Other Intervention Names

Minze diary pod; Minze diary pod

Eligibility Criteria

Inclusion Criteria

1. Females

2. 18 years of age or above

3. Females presenting with lower urinary tract symptoms

1. Female

2. 18 years of age or above

Exclusion Criteria

1.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:

1. Females who have a mental/physical disability which would make them unable to understand/comply with the requirements of the study.

2. Female with (LUTS).

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Birmingham Women's and Children's NHS Foundation Trust

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Philip Toozs-Hobson, MD

Role: PRINCIPAL_INVESTIGATOR

Birmingham Women's NHS Foundation Trust

ILIAS LIAPIS, MD

Role: PRINCIPAL_INVESTIGATOR

Birmingham Women's and Children's Hospital

Locations

Birmingham Women's and Children's Hospital

Birmingham, , United Kingdom

Site Status: RECRUITING

Countries

United Kingdom

Central Contacts

ILIAS LIAPIS

Role: CONTACT

ilias.liapis@nhs.net

(0044)7484887101

Adey

Role: CONTACT

e.adey@nhs.net

(0044)1214721377

Facility Contacts

ILIAS liapis, MD

Role: primary

ilias.liapis@nhs.net

(0044)7484887101

Other Identifiers

296904

Identifier Type: REGISTRY

Identifier Source: secondary_id

22/EM/0152

Identifier Type: OTHER

Identifier Source: secondary_id

22/BW/GYN/NO/628

Identifier Type: -

Identifier Source: org_study_id