Overactive BladderNCT03473782
Overactive Bladder (OAB) Voiding Diary and Urodynamics Correlation Study
An observational study of Overactive Bladder, run by NYU Langone Health at 1 site in United States.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 110 years
- Conditions the study is for
- Overactive Bladder
- What is being tested?
- Voiding Diary and Urodynamics Correlation Study
- How many people
- 123 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Oct 2015to 8 Aug 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 110 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients seen regularly with Overactive Bladder (OAB)
Who may be able to join
- completing a bladder diary
- undergoing VUDS
Who cannot join
- have a urinary tract infection
- neurogenic bladder
- history of pelvic irradiation
- prolapse alone without LUTS
- pregnant
- incarcerated
- hospital employee
- unable to give consent
Trial locations and contacts
1 site in 1 country.
United States1 site
New York University School of Medicine
New York, New York, 10016
About this study
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
- Conditions
- Overactive Bladder
- Being tested
- Voiding Diary, Urodynamics Correlation Study
- Medical subject headings
- Urinary Bladder, Overactive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Voiding DiaryOther
A log kept by each patient to record frequency and volume of urine output and fluid input.
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.
| Study group | Role | What they receive |
|---|---|---|
| Voiding Diary | Not described Receives: Other: Voiding Diary; Other: Urodynamics Correlation Study | |
| Urodynamics Correlation Study | Not described Receives: Other: Voiding Diary; Other: Urodynamics Correlation Study |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measure of urgency incontinence using Voiding Diary
patients will record urgency in diary
Measured: 60 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2018
- Study start12 Oct 2015
- Primary completion8 Aug 2023
- Study completion8 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Overactive BladderStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 123 participants (actual)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Benjamin Brucker, Principal investigator, NYU Langone Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03473782
- Sponsor's protocol ID
- 15-00827
- Status last verified
- Aug 2023
- First submitted
- 16 Mar 2018
- Last updated
- 9 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Overactive Bladder (OAB) Voiding Diary and Urodynamics Correlation Study
- ClinicalTrials.gov ID
- NCT03473782
- Acronym / sponsor ID
- 15-00827
- Conditions
- Overactive Bladder
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 123 participants (actual)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Study start
- 12 Oct 2015 (actual)
- Primary completion
- 8 Aug 2023 (actual)
- Study completion
- 8 Aug 2023 (actual)
- First posted
- 22 Mar 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Voiding Diary | – | Other: Voiding Diary, Other: Urodynamics Correlation Study |
| Urodynamics Correlation Study | – | Other: Voiding Diary, Other: Urodynamics Correlation Study |
Who may qualify
- Ages
- 18 to 110 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients seen regularly with Overactive Bladder (OAB)
Key inclusion criteria (2 listed)
- completing a bladder diary
- undergoing VUDS
Key exclusion criteria (8 listed)
- have a urinary tract infection
- neurogenic bladder
- history of pelvic irradiation
- prolapse alone without LUTS
- pregnant
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Voiding DiaryA log kept by each patient to record frequency and volume of urine output and fluid input. | Other | Urodynamics Correlation Study, Voiding Diary |
| Urodynamics Correlation StudyProvides patho physiological data by assessing bladder sensation, bladder capacity, the presence of involuntary bladder contractions, bladder compliance and bladder outlet obstruction. | Other | Urodynamics Correlation Study, Voiding Diary |
Primary outcome
Measure of urgency incontinence using Voiding Diary
Time frame: 60 Months
patients will record urgency in diary
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Benjamin Brucker principal investigator
NYU Langone Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Overactive Bladder, run by NYU Langone Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measure of urgency incontinence using Voiding Diary (time frame: 60 Months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Aug 2023.