Codesign of an Optical Device to Measure Urine Flow and Volume

Urinary Incontinence Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05576311
• Other study ID #: 10852
• Status: Not yet recruiting
• Start date: November 1, 2022
• Est. completion date: February 28, 2023

Study information

• Verified date: October 2022
• Source: Teesside University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 45
• Est. completion date: February 28, 2023
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Benign Prostatic Hyperplasia
• Hyperplasia
• Overactive Bladder
• Prostatic Hyperplasia
• Underactive Bladder
• Urinary Bladder, Overactive
• Urinary Bladder, Underactive
• Urinary Incontinence
• Urinary Retention
• Urinary Tract Infections

Intervention

Other:
• Focus Group
Focus Groups to capture information about the need for innovation in the diagnosis and monitoring of urinary symptoms.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Teesside University	South Tees Hospitals NHS Foundation Trust

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Understanding the needs of patients and healthcare practitioners for an innovation in the way that changes in bladder function are assessed.	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