Urinary Incontinence Self-Screening for Healthy Aging
Phase: NA
Conditions: Urinary Incontinence
Sponsor: University of British Columbia

 
 
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Urinary Incontinence Self-Screening For Healthy Aging 
 
Study Protocol and Statistical Analysis Plan 
 
April 4, 2018 
 
 

 
 
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Urinary Incontinence Self-Screening For Healthy Aging 
 
o Background 
 
Urinary incontinence (UI) is the involuntary loss of urine that affects 3.5 million 
Canadians, or nearly 10% of the population.1 According to the Canadian Urinary 
Bladder Survey, 16% of men and 33% of women over the age of 40 have symptoms of 
urinary incontinence.2 Urinary incontinence prevalence rates have been reported 
between 9 and 59% in those aged 50 and above.3 The prevalence of incontinence 
increases with age with the Canadian Urinary Bladder Survey 3 reporting an increase in 
urinary symptoms in those 65 years and older. 
 
The impact of UI on older adults can be significant with serious physical, psychological, 
and social consequences.4 UI is associated with serious medical consequences such as 
falls, fractures, institutionalization, and death.5,6 Embarrassment, isolation,7 depression,4 
decreased self-confidence, disruption in normal activities 8 and lowered quality of life 
are pervasive. On average, older adults with UI suffer in silence for four years before 
they seek health care, instead making adjustments in their daily lives to manage the 
incontinence. 9  
 
As many as 50% (or more) of older adults with UI have never discussed or sought help 
from their general practitioner (GP),2,9 often due to erroneous beliefs about 
incontinence, such as the condition being age-related and untreatable. However, older 
adults with UI seeking help from their GPs have reported negative experiences of being 
brushed aside, treated with indifference, and not having their UI-related symptoms 
recognized or prioritized.10 Preference for self-referral over physician referral emerged 
in a recent study 11 with a five year (2010-2015) increase of 480% in self-referral to 
urogynecology, the highest increase in all types of referrals (e.g., specialist, GP).  
 
The importance of early detection and referral is critical. Left undetected and untreated, 
urinary incontinence is a progressive problem that worsens over time creating greater 
management challenges for both patients and health providers. Identification of patients 
with early or less troublesome urinary symptoms may aid in early intervention with 
simple measures (e.g., lifestyle advice, behavioural therapy), and reduce the need for 
more complex and costly treatment.12 Although older adults with UI are receptive to 
being asked about incontinence,13 UI screening has yet to become standard practice.  
As health care has increasingly become patient-centered and shifted responsibility to 
patients, self-screening has greater potential to reach older adults and promote earlier 
identification, referral and intervention.  
 
Self-screening has been shown to have several benefits including enhanced privacy in 
sensitive situations, increased self-awareness, and reaching a wide audience. It has 

 
 
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been used with a variety of populations and health conditions (e.g., cancer) 14 and social 
challenges (e.g., driving) 15 and is well suited to the study of incontinence because of 
the stigma, embarrassment and silence that surrounds this health condition. 
Opportunities for IU self-screening may provide older adults with validation, acceptance, 
support of a problem shrouded in silence and facilitate help seeking. 
 
o Objectives: The overall aim is to increase awareness of urinary incontinence in 
community-based older adults and promote timely treatment. To achieve this aim the 
project objectives will include: 
1. To develop a self-screening process for community-based older adults 
2. To test the use of a self-screening process with community-based older adults 
 
 
o Methods  
 
Study Design:  This study will use a pilot randomized control trial to test the 
effectiveness of a self-screening process with older adults. The hypothesis is that older 
adults exposed to the self-screening process will follow up with health professionals to 
receive help for the UI condition. There will be two groups of older adults. The 
intervention group will participate in self-screening and the control will not be exposed to 
self-screening. Using this approach is necessary to determine whether or not the self-
screening works.  
 
Intervention: 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 18 (See ICIQ-M) 
and women will complete the ICIQ for Females.19 (See ICIQ-F). The ICIQ Male and 
Female are valid and reliable tools, recognized by the International Continence Society, 
and collect more information about urinary symptoms than other tools, an advantage for 
referral purposes. 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 (See UI Fact Sheet).  
 
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.   
 
Setting: Senior's Centers and organizations dedicated to seniors in Kelowna, West 
Kelowna and Lake Country will serve as the recruitment sites for this study. These 
Senior’s Centers/organizations (e.g., Lake Country Seniors Centre, Lake Country 

 
 
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Health Planning Society, Westside Health Network, Seniors Outreach Bureau) serve 
large and different populations of seniors (>300 seniors) so overlap in membership is 
not expected to be an issue.  
 
Sampling and Recruitment: The study sample will include older adults >65 years of 
age (men and women) who attend a local Senior's Centre or organization, report having 
some UI symptoms, are independent living, ambulatory, with 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. Older adults will be excluded if they have cognitive impairment, require 
more than minimal assistance with completing the survey, or have any impairment (e.g., 
vision) that would make self-screening and follow up challenging. They must also never 
have been referred to a UI specialist or program in the past. 
 
Following ethics approval, eligible older adults will be recruited through a letter of 
invitation sent through e-mail distribution lists of our participating seniors 
centres/organizations (see Letter of Invitation). Based on other UI studies, in which 
there was a 14% self-referral rate without an intervention, we hypothesize a 61% 
incremental increase in self-referral in the arm receiving the intervention. 11 The sample 
size required to detect an improvement in self-referral (with 80% power, p<.05) to a 
health professional (e.g., UI specialist) is 24 participants (12 older adults per arm). 
Drop-out or attrition is common in research studies. 16 In factoring the potential for a 
drop-out rate of 50%, a sample size of 36 participants will be recruited. Excel 
randomization function will be used to assign participants to one of the two arms (the 
arm receiving the self-screening process or the arm not receiving this process). The 
randomization assignments (allocations) will be placed in individual sealed envelopes. 
After informed consent is obtained, the Research Assistant (RA) will choose the next 
available envelope to reveal which arm the study participant will be assigned. 
 
Data Collection:  
 
Pre-test: Prior to implementation, the self-screening tool will be pre-tested with 5 older 
adults attending participating seniors centres/organizations. The purpose of the pretest 
will be to identify any implementation issues such as recruitment, administration, 
understanding and ease of use of the self-screening tools.  
 
Procedures: Older adults assigned to both groups will receive follow up from the RA 
who will provide details about the study and answer any questions.  Prior to 
randomization, consenting older adults from both groups will complete a demographic 
(e.g., age, sex, highest level of education, household income), health history profile 
(e.g., co-morbidities, history of previous referrals for UI, medications) (see 
Demographic and Health History Profile) and a quality of life questionnaire 17 (see 
The King’s Health Questionnaire).  
 
Three months following study entry participants from both groups will receive a phone 
follow-up to obtain information about actions they have taken re IU (e.g., self/physician 

 
 
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referral), UI symptoms, 18,19 treatments received, satisfaction with care (See Three 
Month Follow up Questionnaire), and changes in quality of life.17 The follow up phone 
call will be recorded. It is expected the baseline and 3 month follow up data collection 
will take approximately 20-30 minutes to complete.  
 
The primary outcome will be the numbers of older adults who take action to receive help 
for their UI during the 3-month follow-up from study entry: self-referral to the local UI 
clinic, appointment with GP about their UI, and/or referral to a specialist (urologist or 
urogynecologist or gynecologist), or other action. Secondary outcomes will include: 
treatments received, satisfaction with care, changes in quality of life. 19  
 
Post-Intervention Focus Groups: To obtain feedback on the self-screening process, 
focus groups (n=2) will be conducted with older adults (10-12 participants) who were in 
the self-screening group. At the end of 3-months from study entry, in conjunction with 
survey completion, participants will be invited to participate in a focus group. Those 
expressing an interest in focus group participation will be contacted with details of the 
date, time of the focus group and will receive a copy of the semi-structured interview 
questions. Questions will address participants’ comfort with the self-screening process, 
rationale and influences on choice to self-refer or not, barriers/facilitators to self-referral, 
recommendations to make the self-screening process easier (See Focus Group 
Interview Questions).  
 
Data Analysis:  
 
Description of Sample: 
Frequency analysis will be conducted on all demographic (age, sex, highest level of 
education, household income), health history profile (co-morbidities, history of previous 
referrals for UI, medications) and quality of life.  For continuous variables, means with 
associated standard deviations (SD) will be calculated for parametric variables or 
medians with associated interquartile ranges will be calculated for nonparametric 
variables. For categorical variables, percentages with 95% confidence interval (CI) will 
be calculated. These calculations will be calculated for the total study population as well 
as for participants in each study group.  
 
Primary analysis: 
The study hypothesis is that older adults exposed to the self-screening process will 
follow-up with health professionals to receive help for their UI condition more often than 
the control group. To test this hypothesis, investigators will calculate the proportion (with 
95% CI) of participants who self-report as having self-referred to a health professional 
(binary yes/no response) during the study period for each group.  A chi-square test will 
be conducted to determine if the self-screening process is associated with self-referral 
to a health professional.  In addition, a logistic regression analysis will be conducted to 
model the odds of self-referring among people who have undergone self-screening, 
adjusting for demographics, and health history variables.  Bivariate analysis will be 
conducted and variables significantly associated with self-referral will be entered into 
the model. Since the study sample size will only allow for having 3 variables in the 

 
 
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model, more than one regression model may be necessary.  If this is the case, a 
Bonferroni adjustment will be used to account for multiple comparisons.  
 
Secondary analysis:  
 
Quality of life scores will be compared within and between groups.  For the within group 
comparison a two-sided dependent t-test will be conducted using the pre-study and 3-
month quality of life scores for each group.  To determine if a change in quality of life 
(difference between pre-study and 3-month quality of life scores) is statistically 
significant and mixed between-within subjects analysis of variance will be conducted.  
 
All participants will complete a Urinary Symptoms questionnaire (ICIQ-FLUTS) which 
consists of ordinal categorical responses to questions related to urinary symptoms. 
Each question has five response options.  For each question, each response category 
will be assigned a numeric value depending on the severity of the symptom (1= no 
symptoms; 5=severe symptoms). For each participant, improvement in symptoms will 
be determined by a reduction in the ordinal value. Improvement in UI symptoms will be 
compared between groups using a chi-square test.  
 
Investigators are also interested in knowing if self-screening results in a higher 
proportion of participants initiating medication of UI during the study period.  Therefore, 
the proportion of participants in each group who started medication for UI during the 
study period will be compared using a chi-square test.  
 
 
Limitations:  It is possible that screening for eligibility for the study may make a person 
more likely to self-refer. If this occurs in the control arm, it may bias the results toward 
the null hypothesis (i.e. it may be less likely to detect a difference between study arms). 
 
 
  
 
 

 
 
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