Developing a Simple Test to Diagnose Overactive Bladder

NCT05572918 | Unknown DMC

• 1 other identifier: 11043
• Study Type: observational
• Target: 100
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Overactive Bladder; Overactive Bladder Syndrome; Detrusor Overactivity

Outcome Measures

Primary Outcomes (1)

• 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

Interventions

Urodynamics aka filling cystometry DIAGNOSTIC_TEST

Participants will be undergoing a routine diagnostic test to characterise bladder function and volume

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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, to undergo a diagnostic test to characterise bladder function and volume.

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Teesside University: lead
• South Tees Hospitals NHS Foundation Trust: collaborator

Biospecimen

Retention: SAMPLES WITHOUT DNA

Mid-stream urine samples

MeSH Terms

Conditions

Urinary Bladder, Overactive

Condition Hierarchy (Ancestors)

Urinary Bladder Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Translational Healthcare

Study Record Dates

• First Submitted: October 5, 2022
• First Posted: October 10, 2022
• Study Start: December 1, 2022
• Primary Completion: October 31, 2023
• Study Completion: November 30, 2023
• Last Updated: October 12, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share