CClinicalTrials.gg
CompletedNCT02197533Updated Dec 4, 2019

Educating Patients on Management of Overactive Bladder: Written Versus Verbal Instructions

An interventional study of Written List in Overactive Bladder, sponsored by Unity Health Toronto. Completed at 1 site in Canada. Open to female participants. Per ClinicalTrials.gov, last updated 2019-12-04.

Sponsored by Unity Health Toronto · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Randomized
Sex
Female
01

Study summary

Background: Overactive bladder (OAB) is a common condition among postmenopausal women, requiring a multifaceted treatment approach that requires patient retention of information given to them in clinic. Recall of recommendations is a key component of compliance. Supplemental educational tools such as handouts and audiovisual information have been investigated for their ability to improve patients' recall of information and increase satisfaction with the clinical encounter.

Objective: To determine if a written list of seven management strategies for overactive bladder leads to improved immediate and delayed recall of these recommendations in postmenopausal women presenting with OAB compared to a traditional verbal discussion.

Methods: In this single-blind, randomized controlled trial, patients' immediate and delayed (2-week) recall of seven OAB management strategies will be compared between two groups. The intervention group will receive a handwritten list during their verbal discussion of OAB treatment while the control group will receive standard care (verbal discussion only). Immediate and delayed recall will be assessed by a member of the study team who has been blinded to participants' group assignments.

Results: The results of this study may guide clinicians in the most effective mode of providing treatment recommendations to post-menopausal patients with OAB.

02

Conditions studied

  • Overactive Bladder
03

In context

Urinary Bladder, Overactive

855 studies on the registry are indexed under Urinary Bladder, Overactive; 125 are open to participants now.

This study's enrollment of 60 is below the median of 72 across 652 interventional studies indexed under Urinary Bladder, Overactive.

Browse Urinary Bladder, Overactive studies →

Lead sponsor

Unity Health Toronto is the lead sponsor of 434 studies on the registry; 76 are open to participants now.

Of its 5 completed or terminated interventional studies of FDA-regulated products, 1 (20%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
Female
Accepts healthy volunteers
No

Inclusion criteria

  • New diagnosis of overactive bladder
  • post-menopausal

Exclusion criteria

Exclusion Criteria:

  • Pre-existing diagnosis of dementia or other cognitive disorders
  • Patients with mixed incontinence
  • Non-English speaking
  • Patients with contraindications to taking vaginal estrogen or anticholinergic medications
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
60 participants (actual)

Study arms

  • Experimental
    Written list

    Patients in the intervention group will receive both verbal information and a written supplement (Appendix 1), produced during the discussion by CM or a fellow (not the individual who obtained consent), on treatment recommendations for OAB. They will leave clinic with this written list of recommendations and will be able to take it home with them.

    Other: Written List

  • No intervention
    Control

    Patients in the control group will receive the same verbal information on the treatment recommendations for OAB, however, these patients will not receive the written list of management strategies for their condition.

Interventions

  • OtherWritten List

    Written list of seven management strategies for OAB to be produced during verbal discussion about management.

06

What researchers measure

Primary outcomes

  1. Recall

    Mean number of treatment strategies recalled (scored out of seven) immediately and two weeks after the clinic appointment.

    Time frame: 0 and 2 weeks

07

Study locations

1 site
  • St. Michael's Hospital
    Toronto, Ontario M5B1W8, Canada
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 4, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02197533
Lead sponsor
Unity Health Toronto
Responsible party
Sponsor
First posted
Jul 22, 2014
Start date
Jul 2014
Primary completion
Jan 31, 2018
Completion
Sep 1, 2019
Last update
Dec 4, 2019

Study contacts

Colleen McDermott, MD, MSc, FRSCS
principal investigator · Unity Health Toronto

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2019. You cannot join it, but the record below documents what was studied.

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