Electronic Urinary Flowmeter to Improve Accuracy of Bladder Diaries .

NCT05702294 | Completed

• 3 other identifiers: 22/BW/GYN/NO/62829690422/EM/0152
• Study Type: interventional
• Target: 187
• Locations: 1 country
• Sites: 1

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

Conditions

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

Keywords

electronic bladder diaries; paper bladder diaries; Overactive bladder; automated measurement; voided volume; urgency urinary incontinence

Outcome Measures

Primary Outcomes (1)

• 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.

  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.

  After completion of the three day bladder diary ( both paper and electronic version) of all study recruits

Study Arms (1)

Intervention group

EXPERIMENTAL

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.

Device: Diary pod ( measuring vessel that automatically calculates voided volume)

Interventions

Diary pod ( measuring vessel that automatically calculates voided volume) DEVICE

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).

Also known as: Minze diary pod

Intervention group

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Females
• years of age or above
• Females presenting with lower urinary tract symptoms

You may not qualify if:

• 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:
• Female
• years of age or above
• Females who have a mental/physical disability which would make them unable to understand/comply with the requirements of the study.
• Female with (LUTS).

Sponsors & Collaborators

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

Study Sites (1)

Birmingham Women's and Children's Hospital

Birmingham, B15 2TG, United Kingdom

Location

MeSH Terms

Conditions

Lower Urinary Tract Symptoms; Urinary Bladder, Overactive

Condition Hierarchy (Ancestors)

Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Urinary Bladder Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• Philip Toozs-Hobson, MD

  Birmingham Women's NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

• ILIAS LIAPIS, MD

  Birmingham Women's and Children's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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 5% using a flowmeter as the gold standard. The investigators will achieve that by: A. Performing 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 5% using a flowmeter as the gold standard. B. Recruiting healthy volunteers to develop more accurate nomograms of bladder function. The healthy volunteers 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.

Study Record Dates

• First Submitted: December 20, 2022
• First Posted: January 27, 2023
• Study Start: September 14, 2022
• Primary Completion: August 6, 2024
• Study Completion: August 6, 2024
• Last Updated: February 23, 2026

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)