NCT03485872

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
53

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2018

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 7, 2018

Completed
4 days until next milestone

Study Start

First participant enrolled

March 11, 2018

Completed
22 days until next milestone

First Posted

Study publicly available on registry

April 2, 2018

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 2, 2019

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2019

Completed
Last Updated

November 4, 2020

Status Verified

November 1, 2020

Enrollment Period

1.3 years

First QC Date

March 7, 2018

Last Update Submit

November 2, 2020

Conditions

Outcome Measures

Primary Outcomes (1)

  • Self-Referral Questionnaire

    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".

    3 months

Secondary Outcomes (2)

  • Treatments Received Questionnaire

    3 months

  • Satisfaction with Care Questionnaire

    3 months

Study Arms (2)

Self-Screening and Referral Information

EXPERIMENTAL

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

Control Group

ACTIVE COMPARATOR

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

Interventions

Urinary incontinence self-screening questionnaire, fact sheet and self-referral information will be provided by mail or email.

Self-Screening and Referral Information

Demographic and quality of life questionnaires; standard care provided by participants' GPs

Control Group

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of British Columbia

Kelowna, British Columbia, V1V 1V7, Canada

Location

Related Publications (3)

  • Donovan JL, Abrams P, Peters TJ, Kay HE, Reynard J, Chapple C, De La Rosette JJ, Kondo A. The ICS-'BPH' Study: the psychometric validity and reliability of the ICSmale questionnaire. Br J Urol. 1996 Apr;77(4):554-62. doi: 10.1046/j.1464-410x.1996.93013.x.

    PMID: 8777617BACKGROUND
  • Jackson S, Donovan J, Brookes S, Eckford S, Swithinbank L, Abrams P. The Bristol Female Lower Urinary Tract Symptoms questionnaire: development and psychometric testing. Br J Urol. 1996 Jun;77(6):805-12. doi: 10.1046/j.1464-410x.1996.00186.x.

    PMID: 8705212BACKGROUND
  • Okamura K, Nojiri Y, Osuga Y. Reliability and validity of the King's Health Questionnaire for lower urinary tract symptoms in both genders. BJU Int. 2009 Jun;103(12):1673-8. doi: 10.1111/j.1464-410X.2008.08335.x. Epub 2009 Jan 9.

    PMID: 19154505BACKGROUND

MeSH Terms

Conditions

Urinary Incontinence

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Urination DisordersUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesLower Urinary Tract SymptomsUrological ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Quality Indicators, Health CareQuality of Health CareHealth Services AdministrationHealth Care Quality, Access, and Evaluation

Study Officials

  • Kathy Rush, PhD

    University of British Columbia- Okanagan

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SCREENING
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

March 7, 2018

First Posted

April 2, 2018

Study Start

March 11, 2018

Primary Completion

July 2, 2019

Study Completion

August 31, 2019

Last Updated

November 4, 2020

Record last verified: 2020-11

Data Sharing

IPD Sharing
Will not share

Locations