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Trial record 39 of 4986 for:    British | Canada

Urinary Incontinence Self-Screen for Healthy Aging

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03485872
Recruitment Status : Active, not recruiting
First Posted : April 2, 2018
Last Update Posted : May 9, 2019
Retired Teachers of Ontario Foundation
Interior Health
Information provided by (Responsible Party):
Kathy Rush, University of British Columbia

Brief Summary:
The purpose of this study is to increase awareness and timely treatment of urinary incontinence through a self-screening process. This is a 3 month study involving 2 activities; one taking place at the beginning of study and another 3 months later. Participants will be randomized into experimental and control groups. The experimental group will receive a demographic questionnaire, quality of life questionnaire, a questionnaire pertaining to urinary symptoms, information about how to self-screen for urinary incontinence and information regarding how to refer oneself to urinary incontinence resources. The control group will receive the demographic and quality of life questionnaires only. It is estimated that it will take participants 20-30 minutes to complete their package of questionnaires. After 3 months, the participants will receive a phone call inquiring into what actions they have taken regarding their urinary incontinence.

Condition or disease Intervention/treatment Phase
Urinary Incontinence Other: Self-Screening and Referral Information Other: Standard Care Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 36 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Screening
Official Title: Urinary Incontinence Self-Screening for Healthy Aging
Actual Study Start Date : March 11, 2018
Estimated Primary Completion Date : June 2019
Estimated Study Completion Date : June 2019

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Self-Screening and Referral Information
The intervention will include a combination of self-screening and UI specific information and resources. Older adults in the intervention group will complete a gender specific UI Self-Screening tool. Men will complete the International Consultation on Incontinence Modular Questionnaire (ICIQ) for Males and women will complete the ICIQ for Females. In addition, the intervention group will receive a fact sheet with UI specific information, contact information to the local incontinence clinic and a link to a website with patient incontinence resources and education.
Other: Self-Screening and Referral Information
Urinary incontinence self-screening questionnaire, fact sheet and self-referral information will be provided by mail or email.

Active Comparator: Control Group
Older adults assigned to the control group will receive standard care from their physicians. Standard care may differ from general practitioner to general practitioner. Usual care for urinary incontinence (UI) from general practitioners is generally minimal. Most patients do not tell their physicians about UI, and most physicians do not ask about UI. If this topic does come up during a GP appointment, a patient may be offered no treatment, lifestyle advice (e.g., do not drink before bed), told to do Kegels (but likely not instructed how to do these properly) or in some cases, offered pharmacological therapies (which will be captured in our questionnaire with the participants). But standard of care is unfortunately very often no care.
Other: Standard Care
Demographic and quality of life questionnaires; standard care provided by participants' GPs

Primary Outcome Measures :
  1. Self-Referral Questionnaire [ Time Frame: 3 months ]
    The primary outcome will be the number of older adults who take action to receive help for their UI. The following question will be asked through a questionnaire at three month follow-up: "During the past three months, what have you done about the leakage?" Participants will have the option to check off any of the following options: "I haven't done anything about it", "have seen my GP about it", and "referred myself to the local Urinary Incontinence Clinic".

Secondary Outcome Measures :
  1. Treatments Received Questionnaire [ Time Frame: 3 months ]
    The treatments the participants receive as a result of self-referral for their urinary incontinence will be noted. The following question will be asked through a questionnaire at three month follow-up: "What treatments have you received?" Participants will have the option to check off any of the following options: Lifestyle treatments/education by a health care practitioner (ex. fluid management, kegel exercises, etc.)"; "prescription medication treatments"; and "surgical treatments".

  2. Satisfaction with Care Questionnaire [ Time Frame: 3 months ]
    Participants' satisfaction with the care they receive will be observed, factoring in whether or not they received the intervention. The following question will be asked through a questionnaire at three month follow-up: "How satisfied have you been with the care you have been receiving for urinary incontinence?" Participants will have the option to check off one of the following options: "poor", "fair", "good", "very good", or "excellent".

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Adults 65 years of age and older
  • Attend a local Senior's Centre or organization
  • Report having some UI symptoms
  • Living independently
  • Ambulatory
  • No more than mild cognitive impairment
  • Able to read and write in English or have someone who can assist with reading the data collection information and can complete a paper survey independently

Exclusion Criteria:

  • Cognitive impairment
  • Require more than minimal assistance with completing the survey
  • Any impairment (e.g., vision) that would make self-screening and follow up challenging.
  • Have been referred to a UI specialist or continence program in the past

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03485872

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Canada, British Columbia
University of British Columbia
Kelowna, British Columbia, Canada, V1V 1V7
Sponsors and Collaborators
University of British Columbia
Retired Teachers of Ontario Foundation
Interior Health
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Principal Investigator: Kathy Rush, PhD University of British Columbia Okanagan
  Study Documents (Full-Text)

Documents provided by Kathy Rush, University of British Columbia:

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Responsible Party: Kathy Rush, Associate Professor, University of British Columbia Identifier: NCT03485872     History of Changes
Other Study ID Numbers: H17-03037
First Posted: April 2, 2018    Key Record Dates
Last Update Posted: May 9, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Urinary Incontinence
Urination Disorders
Urologic Diseases
Lower Urinary Tract Symptoms
Urological Manifestations
Signs and Symptoms
Behavioral Symptoms
Elimination Disorders
Mental Disorders