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
• Status: Not yet recruiting
• 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
• 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.

Related Conditions & MeSH terms

• Detrusor Overactivity
• Overactive Bladder
• Overactive Bladder Syndrome
• Urinary Bladder, Overactive

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