Codesign of an Optical Device to Measure Urine Flow and Volume

• Sponsor: Teesside University (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05576311
• Collaborator: South Tees Hospitals NHS Foundation Trust (Other)
• Enrollment: 45
• Anticipated Duration (Months): 3.9

Study Details

Study Description

Brief Summary

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).

Condition or Disease	Intervention/Treatment	Phase
Urinary Incontinence; Urinary Retention; Urinary Tract Infections; Overactive Bladder; Benign Prostatic Hyperplasia; Underactive Bladder	Other: Focus Group

Study Design

• Study Type: Observational
• Anticipated Enrollment: 45 participants
• Observational Model: Cohort
• Time Perspective: Cross-Sectional
• Official Title: 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
• Anticipated Study Start Date: Nov 1, 2022
• Anticipated Primary Completion Date: Dec 31, 2022
• Anticipated Study Completion Date: Feb 28, 2023

Outcome Measures

Primary Outcome Measures

1. Understanding the needs of patients and healthcare practitioners for an innovation in the way that changes in bladder function are assessed. [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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Teesside University
• South Tees Hospitals NHS Foundation Trust

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: John S. Young, Professor of Translational Healthcare, Teesside University
• ClinicalTrials.gov Identifier: NCT05576311
• Other Study ID Numbers: 10852
• First Posted: Oct 12, 2022
• Last Update Posted: Oct 12, 2022
• Last Verified: Oct 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Urinary Tract Infections; Urinary Incontinence; Urinary Bladder, Overactive; Prostatic Hyperplasia; Urinary Retention; Urinary Bladder, Underactive; Hyperplasia

Study Results

No Results Posted as of Oct 12, 2022