Developing a Simple Test to Diagnose Overactive Bladder | NCT05572918

Studies
Developing a Simple Test to Diagnose Overactive Bladder

NCT05572918

Sponsor

Teesside University

Status

Unknown status

Last Update Posted

Oct 12, 2022Actual

Enrollment

100Estimated

Phase

Not provided

Conditions

Overactive Bladder
Overactive Bladder Syndrome
Detrusor Overactivity

Interventions

Urodynamics aka filling cystometry

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2022

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 1, 2022Estimated

Primary Completion Date

Oct 31, 2023Estimated

Completion Date

Nov 30, 2023Estimated

First Submitted Date

Oct 5, 2022

First Submission Date that Met QC Criteria

Oct 5, 2022

First Posted Date

Oct 10, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 7, 2022

Last Update Posted Date

Oct 12, 2022Actual

Name	Class
South Tees Hospitals NHS Foundation Trust	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

100Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Urodynamics aka filling cystometry	Diagnostic Test	Participants will be undergoing a routine diagnostic test to characterise bladder function and volume

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

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.

Sampling Method

Non-Probability Sample

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D053201	Urinary Bladder, Overactive

Ancestor Terms

ID	Term
D001745	Urinary Bladder Diseases
D014570	Urologic Diseases
D052776	Female Urogenital Diseases
D005261	Female Urogenital Diseases and Pregnancy Complications

Browse Leaves

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Browse Branches

Not provided