Codesign of an Optical Device to Measure Urine Flow and Volume

NCT05576311 | Unknown DMC

• 1 other identifier: 10852
• Study Type: observational
• Target: 45
• Locations: 0 countries
• Sites: N/A

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).

Conditions

Urinary Incontinence; Urinary Retention; Urinary Tract Infections; Overactive Bladder; Benign Prostatic Hyperplasia; Underactive Bladder

Outcome Measures

Primary Outcomes (1)

• 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

Interventions

Focus Group OTHER

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Aged 18 years or above. Male or Female.

You may not qualify if:

• Aged 17 years or younger.

Sponsors & Collaborators

• Teesside University: lead
• South Tees Hospitals NHS Foundation Trust: collaborator

MeSH Terms

Conditions

Urinary Incontinence; Urinary Retention; Urinary Tract Infections; Urinary Bladder, Overactive; Prostatic Hyperplasia; Urinary Bladder, Underactive

Interventions

Focus Groups

Condition Hierarchy (Ancestors)

Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Infections; Urinary Bladder Diseases; Prostatic Diseases; Genital Diseases, Male; Genital Diseases

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Translational Healthcare

Study Record Dates

• First Submitted: October 5, 2022
• First Posted: October 12, 2022
• Study Start: November 1, 2022
• Primary Completion: December 31, 2022
• Study Completion: February 28, 2023
• Last Updated: October 12, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share