Developing a Simple Test to Diagnose Overactive Bladder

Not yet recruiting

• Conditions: Overactive Bladder; Detrusor Overactivity; Overactive Bladder Syndrome

• Registration Number: NCT05572918
• Lead Sponsor: Teesside University

Brief 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2022-10
• Study First Submitted: 2022-10-05
• Study First Submitted QC: 2022-10-05
• Last Update Submitted: 2022-10-07
• Study First Posted: 2022-10-10
• Last Update Posted: 2022-10-12
• Study Start: 2022-12-01
• Primary Completion: 2023-10-31
• Study Completion: 2023-11-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 100

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Assessment of accuracy of a diagnostic test for overactive bladder	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.