Developing a Simple Test to Diagnose Overactive Bladder

NCT ID: NCT05572918

Last Updated: 2022-10-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-12-01

Study Completion Date

2023-11-30

Brief Summary

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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

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Conditions

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Overactive Bladder Overactive Bladder Syndrome Detrusor Overactivity

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Interventions

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Urodynamics aka filling cystometry

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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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South Tees Hospitals NHS Foundation Trust

OTHER

Sponsor Role collaborator

Teesside University

OTHER

Sponsor Role lead

Responsible Party

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John S. Young

Professor of Translational Healthcare

Responsibility Role PRINCIPAL_INVESTIGATOR

Other Identifiers

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11043

Identifier Type: -

Identifier Source: org_study_id

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