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Developing a Simple Test to Diagnose Overactive Bladder

Sponsor
Teesside University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05572918
Collaborator
South Tees Hospitals NHS Foundation Trust (Other)
100
Enrollment
12
Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: Urodynamics aka filling cystometry

Study Design

Study Type:
Observational
Anticipated Enrollment :
100 participants
Observational Model:
Case-Only
Time Perspective:
Prospective
Official Title:
Translation of a Novel Overactive Bladder 'Fingerprint' Into a Breakthrough Non-invasive Diagnostic Test for Use in a Point of Care Setting
Anticipated Study Start Date :
Dec 1, 2022
Anticipated Primary Completion Date :
Oct 31, 2023
Anticipated Study Completion Date :
Nov 30, 2023

Outcome Measures

Primary Outcome Measures

  1. 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Teesside University
  • South Tees Hospitals NHS Foundation Trust

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
John S. Young, Professor of Translational Healthcare, Teesside University
ClinicalTrials.gov Identifier:
NCT05572918
Other Study ID Numbers:
  • 11043
First Posted:
Oct 10, 2022
Last Update Posted:
Oct 12, 2022
Last Verified:
Oct 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Urinary Bladder, Overactive

Study Results

No Results Posted as of Oct 12, 2022