NCT02670486

Brief Summary

Many women have the need to run to the restroom frequently during the night and day, a condition called "overactive bladder". Embarrassing urinary leakage is also commonly associated with these symptoms. The investigators believe the primary cause in most cases is the bladder muscle contracting too frequently but are still not sure exactly why this happens and if it is triggered by factors in the environment. When bladder testing using pressure catheters ("urodynamics") is done these bladder contractions are often not picked up, even in women with overactive bladder. This may be partly due to the unnatural environment in which the testing is done without the presence of the usual visual or audible triggers, such as running water or seeing a toilet. The investigators propose adding an audiovisual stimulant to the usual bladder testing to see if this makes it more likely for bladder contractions to happen. One group of patients would have the usual bladder testing as part of their normal care. The other group would receive the normal care in addition to hearing a water fountain in the room and watching a video of things that may trigger overactive bladder symptoms; seeing public restroom signs in a mall, a toilet bowl being lowered and a kitchen sink with water running over dishes. The suspicion is that the proportion of patients in whom bladder contractions are seen will be higher for those with audiovisual triggers compared to those with the usual care. Women with overactive bladder or leakage with urge who are sent for urodynamics by their doctor will be asked if they wish to participate in the study.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
218

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2014

Typical duration for not_applicable

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2014

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

October 9, 2015

Completed
4 months until next milestone

First Posted

Study publicly available on registry

February 1, 2016

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2016

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2016

Completed
Last Updated

May 10, 2017

Status Verified

May 1, 2017

Enrollment Period

1.8 years

First QC Date

October 9, 2015

Last Update Submit

May 9, 2017

Conditions

Overactive Bladder

Keywords

Overactive bladderUrge urinary incontinenceUrodynamics

Outcome Measures

Primary Outcomes (1)

  • Proportion of patients in whom detrusor contractions are seen

    30 minutes

Secondary Outcomes (1)

  • Presence of incontinence associated with a contraction

    30 minutes

Study Arms (2)

standard of care

NO INTERVENTION

Usual urodynamics with no intervention.

Audiovisual intervention

ACTIVE COMPARATOR

Audiovisual stimulus during urodynamic testing.

Other: Audiovisual stimulus

Interventions

Audiovisual stimulusOTHER

Water fountain and a video (including scenes of some common triggers for OAB) played on continuous loop throughout the test on a laptop

Audiovisual intervention

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • women 18 years and older undergoing UDE with clinical diagnosis of OAB and/or UUI

You may not qualify if:

  • urinary tract infection
  • pregnancy
  • current treatment for OAB or UUI
  • stage 3 and 4 pelvic organ prolapse
  • undergone major pelvic reconstructive surgery or incontinence surgery in the last 6 months
  • neurogenic bladder

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Urinary Bladder, OveractiveUrinary Incontinence, Urge

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 SymptomsUrinary IncontinenceUrination Disorders

Study Officials

  • Alexandra Caffrey, BS

    Women & Infants Hospital IRB

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PI

Study Record Dates

First Submitted

October 9, 2015

First Posted

February 1, 2016

Study Start

August 1, 2014

Primary Completion

May 1, 2016

Study Completion

June 1, 2016

Last Updated

May 10, 2017

Record last verified: 2017-05

Data Sharing

IPD Sharing
Will not share