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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02197533
Other study ID # 14-213
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date July 2014
Est. completion date September 1, 2019

Study information

Verified date December 2019
Source St. Michael's Hospital, Toronto
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 60
Est. completion date September 1, 2019
Est. primary completion date January 31, 2018
Accepts healthy volunteers No
Gender Female
Age group N/A and older
Eligibility Inclusion Criteria:

- New diagnosis of overactive bladder

- post-menopausal

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

Study Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
Canada St. Michael's Hospital Toronto Ontario

Sponsors (1)

Lead Sponsor Collaborator
St. Michael's Hospital, Toronto

Country where clinical trial is conducted

Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary Recall Mean number of treatment strategies recalled (scored out of seven) immediately and two weeks after the clinic appointment. 0 and 2 weeks
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