Overactive BladderNCT05572918
Developing a Simple Test to Diagnose Overactive Bladder
An observational study of Overactive Bladder and Overactive Bladder Syndrome, run by Teesside University.
Trial summary
In order to develop a test to diagnose overactive bladder from urine, it is essential that this test is at least as accurate as the tools that clinicians currently use. As such, this study will compare the performance of the device in development to the performance of existing methods. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Overactive Bladder, Overactive Bladder Syndrome, Detrusor Overactivity
- What is being tested?
- Urodynamics aka filling cystometry
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2022to 30 Nov 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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, to undergo a diagnostic test to characterise bladder function and volume.
Who may be able to join
- The participant is willing and able to give informed consent for participation in the study
- The participant has been diagnosed with over-active bladder
- Aged 18 years or above
- Male or Female
Who cannot join
- The participant is unwilling to give informed consent for participation in the study
- The participant is unable to represent their own interests or is particularly susceptible to coercion (i.e. is deemed as vulnerable)
- The participant has been diagnosed with neurologic disease (stroke, MS, Parkinson's disease, spinal cord injury); history of uterine, cervical, vaginal or urethral cancer; history of cyclophosphamide use or any type of chemical cystitis; history of benign or malignant bladder tumours; has had Botulinum injections, neuromodulation or augmentation cystoplasty
- Aged 17 years or younger.
About this study
Official title: Translation of a Novel Overactive Bladder 'Fingerprint' Into a Breakthrough Non-invasive Diagnostic Test for Use in a Point of Care Setting
In order to develop a test to diagnose overactive bladder from urine, it is essential that this test is at least as accurate as the tools that clinicians currently use. As such, this study will compare the performance of the device in development to the performance of existing methods.
- Being tested
- Urodynamics aka filling cystometry
- Medical subject headings
- Urinary Bladder, Overactive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Urodynamics aka filling cystometryDiagnostic test
Participants will be undergoing a routine diagnostic test to characterise bladder function and volume
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of accuracy of a diagnostic test for overactive bladder
A prototype lateral flow immunoassay dipstick to detect specific urinary biomarkers for OAB, based on specific urinary biomarkers and with a dynamic range and sensitivity required for accurate OAB diagnosis.
Measured: December 2022 - November 2023
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2022
- Study start1 Dec 2022 (estimated)
- Primary completion31 Oct 2023 (estimated)
- Study completion30 Nov 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Overactive BladderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Teesside University
- Sponsor type
- University, hospital or other
- Collaborators
- South Tees Hospitals NHS Foundation Trust
- Responsible party
- Principal investigator, John S. Young, Teesside University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05572918
- Sponsor's protocol ID
- 11043
- Status last verified
- Oct 2022
- First submitted
- 5 Oct 2022
- Last updated
- 12 Oct 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Translation of a Novel Overactive Bladder 'Fingerprint' Into a Breakthrough Non-invasive Diagnostic Test for Use in a Point of Care Setting
- ClinicalTrials.gov ID
- NCT05572918
- Acronym / sponsor ID
- 11043
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Teesside UniversityUniversity, hospital or other
- Collaborators
- South Tees Hospitals NHS Foundation Trust
- Study start
- 1 Dec 2022 (estimated)
- Primary completion
- 31 Oct 2023 (estimated)
- Study completion
- 30 Nov 2023 (estimated)
- First posted
- 10 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In order to develop a test to diagnose overactive bladder from urine, it is essential that this test is at least as accurate as the tools that clinicians currently use. As such, this study will compare the performance of the device in development to the performance of existing methods.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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, to undergo a diagnostic test to characterise bladder function and volume.
Key inclusion criteria (4 listed)
- The participant is willing and able to give informed consent for participation in the study
- The participant has been diagnosed with over-active bladder
- Aged 18 years or above
- Male or Female
Key exclusion criteria (4 listed)
- The participant is unwilling to give informed consent for participation in the study
- The participant is unable to represent their own interests or is particularly susceptible to coercion (i.e. is deemed as vulnerable)
- The participant has been diagnosed with neurologic disease (stroke, MS, Parkinson's disease, spinal cord injury); history of uterine, cervical, vaginal or urethral cancer; history of cyclophosphamide use or any type of chemical cystitis; history of benign or malignant bladder tumours; has had Botulinum injections, neuromodulation or augmentation cystoplasty
- Aged 17 years or younger.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Urodynamics aka filling cystometryParticipants will be undergoing a routine diagnostic test to characterise bladder function and volume | Diagnostic test | – |
Primary outcome
Assessment of accuracy of a diagnostic test for overactive bladder
Time frame: December 2022 - November 2023
A prototype lateral flow immunoassay dipstick to detect specific urinary biomarkers for OAB, based on specific urinary biomarkers and with a dynamic range and sensitivity required for accurate OAB diagnosis.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Oct 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Overactive Bladder and Overactive Bladder Syndrome, run by Teesside University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of accuracy of a diagnostic test for overactive bladder (time frame: December 2022 - November 2023). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Oct 2022.