- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03473782
Overactive Bladder (OAB) Voiding Diary and Urodynamics Correlation Study
August 8, 2023 updated by: NYU Langone Health
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
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
123
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
New York
-
New York, New York, United States, 10016
- New York University School of Medicine
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 110 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample
Study Population
Patients seen regularly with Overactive Bladder (OAB)
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Voiding Diary
|
A log kept by each patient to record frequency and volume of urine output and fluid input.
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
|
A log kept by each patient to record frequency and volume of urine output and fluid input.
Provides patho physiological data by assessing bladder sensation, bladder capacity, the presence of involuntary bladder contractions, bladder compliance and bladder outlet obstruction.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Measure of urgency incontinence using Voiding Diary
Time Frame: 60 Months
|
patients will record urgency in diary
|
60 Months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Benjamin Brucker, NYU Langone Health
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 12, 2015
Primary Completion (Actual)
August 8, 2023
Study Completion (Actual)
August 8, 2023
Study Registration Dates
First Submitted
March 16, 2018
First Submitted That Met QC Criteria
March 16, 2018
First Posted (Actual)
March 22, 2018
Study Record Updates
Last Update Posted (Actual)
August 9, 2023
Last Update Submitted That Met QC Criteria
August 8, 2023
Last Verified
August 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 15-00827
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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