ClinicalTrials.gg
Status unknownNCT05576311Updated Oct 12, 2022

Codesign of an Optical Device to Measure Urine Flow and Volume

An observational study in Urinary Incontinence, Urinary Retention and Urinary Tract Infections, sponsored by Teesside University. Status unknown. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-10-12.

Sponsored by Teesside University · Observational

The sponsor has not verified this record recently (last verified Oct 2022), so the status shown — last known as Not yet recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Cross-sectional
Enrollment
45
Ages
18 Years and older
Sex
All
01

Study 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).

02

Conditions studied

  • Urinary Incontinence
  • Urinary Retention
  • Urinary Tract Infections
  • Overactive Bladder
  • Benign Prostatic Hyperplasia
  • Underactive Bladder
03

In context

Urinary Incontinence

983 studies on the registry are indexed under Urinary Incontinence; 180 are open to participants now.

This study's planned enrollment of 45 is below the median of 120 across 215 observational studies indexed under Urinary Incontinence.

Browse Urinary Incontinence studies →

Lead sponsor

Teesside University is the lead sponsor of 55 studies on the registry; 10 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
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.

Eligibility criteria

Inclusion criteria The participant is willing and able to give 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.

Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Observational model
Cohort
Time perspective
Cross-sectional
Enrollment
45 participants (estimated)
Patient registry
No

Interventions

  • OtherFocus Group

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

06

What researchers measure

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.

    Time frame: November 2022 - February 2023

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Start is estimated for Nov 2022; primary completion for Dec 2022, 1 month later.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 5, 2022
First posted
Oct 12, 2022
StartEst.
Nov 1, 2022
Primary completionEst.
Dec 31, 2022
CompletionEst.
Feb 28, 2023
Last update
Oct 12, 2022
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Oct 12, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05576311
Lead sponsor
Teesside University
Collaborators
South Tees Hospitals NHS Foundation Trust
Responsible party
John S. Young (Professor of Translational Healthcare, Teesside University) — Principal investigator
First posted
Oct 12, 2022
Start date
Nov 1, 2022 (estimated)
Primary completion
Dec 31, 2022 (estimated)
Completion
Feb 28, 2023 (estimated)
Last update
Oct 12, 2022

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Oct 2022. You cannot join it, but the record below documents what was studied.

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