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NCT05572918 Clinical Trial

Developing a Simple Test to Diagnose Overactive Bladder

Overactive Bladder Clinical Trial

Official title:
Translation of a Novel Overactive Bladder 'Fingerprint' Into a Breakthrough Non-invasive Diagnostic Test for Use in a Point of Care Setting

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT05572918
Other study ID # 11043
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date December 1, 2022
Est. completion date November 30, 2023

Study information
Verified date October 2022
Source Teesside University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 100
Est. completion date November 30, 2023
Est. primary completion date October 31, 2023
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 - The participant has been diagnosed with over-active bladder - Aged 18 years or above - Male or Female Exclusion Criteria: - 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.

Study Design

Related Conditions & MeSH terms

Intervention

Diagnostic Test:
• Urodynamics aka filling cystometry
Participants will be undergoing a routine diagnostic test to characterise bladder function and volume

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 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. December 2022 - November 2023
See also
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Not yet recruiting NCT01423838 - Comparison of Solifenacin and Oxybutynin in the Treatment of Overactive Bladder Phase 4
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