NCT03473782

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
123

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Oct 2015

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 12, 2015

Completed
2.4 years until next milestone

First Submitted

Initial submission to the registry

March 16, 2018

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 22, 2018

Completed
5.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 8, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 8, 2023

Completed
Last Updated

August 9, 2023

Status Verified

August 1, 2023

Enrollment Period

7.8 years

First QC Date

March 16, 2018

Last Update Submit

August 8, 2023

Conditions

Overactive Bladder

Outcome Measures

Primary Outcomes (1)

  • Measure of urgency incontinence using Voiding Diary

    patients will record urgency in diary

    60 Months

Study Arms (2)

Voiding Diary

Other: Voiding DiaryOther: Urodynamics Correlation Study

Urodynamics Correlation Study

Other: Voiding DiaryOther: Urodynamics Correlation Study

Interventions

Voiding DiaryOTHER

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

Urodynamics Correlation StudyVoiding Diary
Urodynamics Correlation StudyOTHER

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

Urodynamics Correlation StudyVoiding Diary

Eligibility Criteria

Age18 Years - 110 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients seen regularly with Overactive Bladder (OAB)

You may qualify if:

  • completing a bladder diary
  • undergoing VUDS

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

New York University School of Medicine

New York, New York, 10016, United States

Location

MeSH Terms

Conditions

Urinary Bladder, Overactive

Condition Hierarchy (Ancestors)

Urinary Bladder DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesLower Urinary Tract SymptomsUrological ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Benjamin Brucker

    NYU Langone Health

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 16, 2018

First Posted

March 22, 2018

Study Start

October 12, 2015

Primary Completion

August 8, 2023

Study Completion

August 8, 2023

Last Updated

August 9, 2023

Record last verified: 2023-08

Locations

US(1)