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Overactive Bladder (OAB) Voiding Diary and Urodynamics Correlation Study

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ClinicalTrials.gov Identifier: NCT03473782
Recruitment Status : Recruiting
First Posted : March 22, 2018
Last Update Posted : February 22, 2022
Sponsor:
Information provided by (Responsible Party):
NYU Langone Health

Study Description
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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
Overactive Bladder Other: Voiding Diary Other: Urodynamics Correlation Study

Study Design
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Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Overactive Bladder (OAB) Voiding Diary and Urodynamics Correlation Study
Actual Study Start Date : September 2016
Estimated Primary Completion Date : June 27, 2022
Estimated Study Completion Date : June 27, 2022

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort 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
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Primary Outcome Measures :
  1. Measure of urgency incontinence using Voiding Diary [ Time Frame: 60 Months ]
    patients will record urgency in diary


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 110 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients seen regularly with Overactive Bladder (OAB)
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03473782


Contacts
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Contact: Alice Drain Alice.Drain@nyulangone.org

Locations
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United States, New York
New York University School of Medicine Recruiting
New York, New York, United States, 10016
Principal Investigator: Mark Pochapin, MD         
Sponsors and Collaborators
NYU Langone Health
Investigators
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Principal Investigator: Benjamin Brucker NYU Langone Health
More Information
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Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
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Responsible Party: NYU Langone Health
ClinicalTrials.gov Identifier: NCT03473782    
Other Study ID Numbers: 15-00827
First Posted: March 22, 2018    Key Record Dates
Last Update Posted: February 22, 2022
Last Verified: February 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Urinary Bladder, Overactive
Urinary Bladder Diseases
Urologic Diseases
Lower Urinary Tract Symptoms
Urological Manifestations