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Recruiting NCT05702294

Electronic Urinary Flowmeter to Improve Accuracy of Bladder Diaries .

Conditions: Lower Urinary Tract Symptoms, Healthy

Sex: Female
Ages: 18 Years – N/A
Healthy volunteers: 1
Phase: NA
Enrollment: 200
Sponsor: Birmingham Women's and Children's NHS Foundation Trust

Location: United Kingdom

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

Eligibility Criteria

Eligibility criteria for females with lower urinary tract symptoms:Inclusion Criteria:Females18 years of age or aboveFemales presenting with lower urinary tract symptomsExclusion 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:Inclusion criteriaFemale18 years of age or aboveExclusion criteriaFemales who have a mental/physical disability which would make them unable to understand/comply with the requirements of the study.Female with (LUTS).

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT05702294). StuddyBuddy aggregates publicly available trial information.