Codesign of an Optical Device to Measure Urine Flow and Volume

October 7, 2022 updated by: John S. Young, Teesside University

Conducting Focus Groups With Patients and Healthcare Practitioners to Inform the Development of a Sensor Which Measures Urine Flow, Volume and Voiding Patterns, in Order to Diagnose Pathologies of the Urinary System

The study is seeking to understand the needs of patients and healthcare practitioners for an innovation in the way that changes in bladder function are assessed. This information will be used in the design and evaluation of a device, being developed in parallel, that assesses changes to the volume and flow of urine in order to determine changes in bladder function.

In order to ensure development is optimal, the principal research objective is therefore to understand the needs of patients and healthcare practitioners (ranging from care home staff and GPs in primary care, to urologists in tertiary referral centres).

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

45

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Participants will be patients with urinary symptoms referred to Consultant Urological Surgeon Ms Mehwash Nadeem at the James Cook Hospital, Middlesbrough or the Friarage Hospital, Northallerton.

Description

Inclusion criteria The participant is willing and able to give informed consent for participation in the study.

Aged 18 years or above. Male or Female.

Exclusion criteria The participant is unwilling or unable to give informed consent for participation in the study.

Aged 17 years or younger.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Cross-Sectional

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Understanding the needs of patients and healthcare practitioners for an innovation in the way that changes in bladder function are assessed.
Time Frame: November 2022 - February 2023
For ~45 participants for each of two categories, patients and healthcare practitioners, focus groups will chart the difficulties, needs, potential solutions, and concerns of all participants, as well as collect their input on the prototype that we are developing. Their responses will be coded, grouped, and summarised, to create a set of guidelines aiding the future development of solutions for urinary disorders.
November 2022 - February 2023

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Teesside University

Collaborators

South Tees Hospitals NHS Foundation Trust

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

November 1, 2022

Primary Completion (Anticipated)

December 31, 2022

Study Completion (Anticipated)

February 28, 2023

Study Registration Dates

First Submitted

October 5, 2022

First Submitted That Met QC Criteria

October 7, 2022

First Posted (Actual)

October 12, 2022

Study Record Updates

Last Update Posted (Actual)

October 12, 2022

Last Update Submitted That Met QC Criteria

October 7, 2022

Last Verified

October 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 10852 (Registry Identifier: DAIDS-ES)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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