Overactive Bladder (OAB) Voiding Diary and Urodynamics Co... | NCT03473782

Studies
Overactive Bladder (OAB) Voiding Diary and Urodynamics Correlation Study

NCT03473782

Sponsor

NYU Langone Health

Status

Completed

Last Update Posted

Aug 9, 2023Actual

Enrollment

123Actual

Phase

Not provided

Conditions

Overactive Bladder

Interventions

Voiding Diary
Urodynamics Correlation Study

Countries

United States

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

Aug 2023

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 12, 2015Actual

Primary Completion Date

Aug 8, 2023Actual

Completion Date

Aug 8, 2023Actual

First Submitted Date

Mar 16, 2018

First Submission Date that Met QC Criteria

Mar 16, 2018

First Posted Date

Mar 22, 2018Actual

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

Aug 8, 2023

Last Update Posted Date

Aug 9, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

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

This is a prospective cohort study study with the primary aim of identifying the strongest correlating parameters between voiding diaries and UDS studies most predictive for each type of urologic condition. Investigators will focus on OAB related conditions, as these are symptoms

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

No data available

No data is available for this block.

Enrollment

123Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Voiding Diary			Other: Voiding Diary Other: Urodynamics Correlation Study
Urodynamics Correlation Study			Other: Voiding Diary Other: Urodynamics Correlation Study

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Voiding Diary	Other	A log kept by each patient to record frequency and volume of urine output and fluid input.	Urodynamics Correlation Study Voiding Diary

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Measure of urgency incontinence using Voiding Diary	patients will record urgency in diary	60 Months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

completing a bladder diary
undergoing VUDS

Exclusion Criteria:

have a urinary tract infection
neurogenic bladder
history of pelvic irradiation
prolapse alone without LUTS
pregnant
incarcerated
hospital employee
unable to give consent

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

110 Years

Standard Ages

AdultOlder Adult

Study Population

Patients seen regularly with Overactive Bladder (OAB)

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Benjamin Brucker	NYU Langone Health	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
New York University School of Medicine		New York	New York	10016	United States

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

Not provided

Browse Branches

Not provided