Overactive Bladder (OAB) Voiding Diary and Urodynamics Correlation Study

Sponsor

NYU Langone Health (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT03473782

Collaborator

(none)

200

Enrollment

Location

81.8

Anticipated Duration (Months)

2.4

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Overactive Bladder	Other: Voiding Diary Other: Urodynamics Correlation Study

Study Design

Study Type:

Observational

Anticipated Enrollment :

200 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Overactive Bladder (OAB) Voiding Diary and Urodynamics Correlation Study

Actual Study Start Date :

Sep 1, 2016

Anticipated Primary Completion Date :

Jun 27, 2023

Anticipated Study Completion Date :

Jun 27, 2023

Arms and Interventions

Arm	Intervention/Treatment
Voiding Diary	Other: Voiding Diary A log kept by each patient to record frequency and volume of urine output and fluid input. Other: Urodynamics Correlation Study Provides patho physiological data by assessing bladder sensation, bladder capacity, the presence of involuntary bladder contractions, bladder compliance and bladder outlet obstruction.
Urodynamics Correlation Study	Other: Voiding Diary A log kept by each patient to record frequency and volume of urine output and fluid input. Other: Urodynamics Correlation Study Provides patho physiological data by assessing bladder sensation, bladder capacity, the presence of involuntary bladder contractions, bladder compliance and bladder outlet obstruction.

Arm

Intervention/Treatment

Voiding Diary

Other: Voiding Diary

A log kept by each patient to record frequency and volume of urine output and fluid input.

Other: Urodynamics Correlation Study

Provides patho physiological data by assessing bladder sensation, bladder capacity, the presence of involuntary bladder contractions, bladder compliance and bladder outlet obstruction.

Urodynamics Correlation Study

Other: Voiding Diary

A log kept by each patient to record frequency and volume of urine output and fluid input.

Other: Urodynamics Correlation Study

Provides patho physiological data by assessing bladder sensation, bladder capacity, the presence of involuntary bladder contractions, bladder compliance and bladder outlet obstruction.

Outcome Measures

Primary Outcome Measures

Measure of urgency incontinence using Voiding Diary [60 Months]
patients will record urgency in diary

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 110 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	New York University School of Medicine	New York	New York	United States	10016

Sponsors and Collaborators

NYU Langone Health

Investigators

Principal Investigator: Benjamin Brucker, NYU Langone Health

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

NYU Langone Health

ClinicalTrials.gov Identifier:

NCT03473782

Other Study ID Numbers:

15-00827

First Posted:

Mar 22, 2018

Last Update Posted:

Aug 19, 2022

Last Verified:

Aug 1, 2022

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Urinary Bladder, Overactive

Study Results

No Results Posted as of Aug 19, 2022