Pilot Trial of Non-Surgical Management for Women With Cystic Fibrosis and Urinary Incontinence
Phase: NA
Conditions: Urinary Incontinence, Cystic Fibrosis
Sponsor: Megan Bradley

 
P.I. ____Bradley, Megan_________________ 
CFF C-P&F –2020 
 
 
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TITLE: CYSTIC FIBROSIS AND URINARY INCONTINENCE 
NCT04922255 
DOCUMENT DATE: 8/5/2020 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
P.I. ____Bradley, Megan_________________ 
CFF C-P&F –2020 
 
 
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RESEARCH PLAN 
 
A. HYPOTHESIS AND SPECIFIC AIMS  
With advancing treatments and management, the median life expectancy of people with cystic fibrosis (CF) 
has increased into the fifth decade of life.1 As women with CF age, focus has shifted to previously overlooked 
aspects of care including sexual and reproductive health.2 Urinary incontinence (UI), defined as the complaint 
of involuntary loss of urine,3 is an understudied component of the lives of many women with CF. Previous work 
investigating incontinence in adult women with CF has reported a prevalence of 30-76% with associated 
impaired quality of life.4–6 In general, UI is categorized as 1) stress urinary incontinence (SUI), related to effort 
or physical exertion including coughing, 2) urgency urinary incontinence (UUI), related to loss of urine 
associated with urgency, or 3) a combination of both, deemed mixed incontinence (MUI). Although it is 
reported that the majority of women with CF and UI experience stress leakage secondary to chronic cough and 
use of chest physiotherapy,7,8, there has never been an objective investigation categorizing the type of UI 
experienced by this population. Ultimately, not enough is known about the characteristics of UI in women with 
CF, and this lack of data limits the ability of providers to make recommendations regarding treatment options. 
Furthermore, the impact of highly effective modulator therapy (HEMT) on coughing and resultant UI is 
unknown. Accepted nonsurgical therapies for UI include behavioral therapies such as bladder training and 
pelvic floor muscle training (PFMT)9 or intravaginal mechanical devices.10,11 There are also newer absorbent 
products for UI that may be preferred over disposable pads.12 Surgical alternatives for UI do exist, but these 
are considered second or third line and are preferred only in women who have completed childbearing.11,13 
Very small studies have begun to investigate the improvement of symptoms in women with CF after PFMT,14 
but additional research surrounding treatment modalities and larger studies are imperative.  
The overall aim of this project is to investigate symptoms and quality of life of women with CF and UI, 
to document objective exam findings, and to perform a feasibility and tolerability study of common 
non-surgical management options for UI.15 We hypothesize that treatment adherence and tolerability of 
PFMT may be less than with reusable absorbent underwear or disposable intravaginal devise and that the 
majority of women with CF and UI will have objective SUI on exam. Through the application of well-established 
clinical and qualitative research methodologies, we will provide a rigorous investigation of UI in women with 
CF. We will take important steps towards improving the treatment of women with CF and UI, and inform the 
design of a larger, multi-center, randomized trial of treatment modalities. 
 
Specific Aim 1 – Explore the experiences, attitudes, and knowledge of women with CF related to UI and 
potential treatment modalities. We will conduct individual, semi-structured interviews with women with CF 
with UI (n~20-30) to assess how UI impacts symptoms and quality of life, evaluate barriers they experience 
regarding access to care/treatment, assess knowledge of available treatment for UI, and determine factors that 
influence decision-making surrounding treatment options. Subjects will be recruited primarily through the Cystic 
Fibrosis Foundation’s Community Voice registry. 
Hypothesis: Women with CF will report UI symptoms, decreased quality of life, limited knowledge about 
potential treatments and preference towards treatment with low time commitments. 
Specific Aim 2 – Evaluate the feasibility of a randomized controlled trial of non-surgical UI 
management options for women with CF. We will complete a pilot, feasibility study (n=30) to compare 
tolerability and symptom relief in women with CF and UI. Subjects will be recruited from both study sites after 
demonstrating bother from UI on standard questionnaires. They will undergo UI questionnaires and undergo a 
pelvic examination, non-invasive bladder scan ultrasound and a provocative stress test and then be 
randomized to either a disposable urethral support device (Impressa®), an absorbent product (Speax 
Reusable Underwear), or PFMT. Our primary outcome will be to determine the feasibility and tolerability of 
these options.  
Hypothesis: All three non-surgical UI management options for women are feasible (as measured by 80% 
adherence to treatment assignment over 7 days) and tolerable (as measured by patient report via 
questionnaire). 
 

 
P.I. ____Bradley, Megan_________________ 
CFF C-P&F –2020 
 
 
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The results from our proposed aims will provide important information about the experiences and symptom 
burden of women with CF and UI. Importantly, we will also be able to answer the important questions of “Can it 
work?” and “Does it work?”15 as we seek to construct the definitive, adequately powered trial of these therapies 
in women with CF and UI.  
 
B. INNOVATION STATEMENT:  
This proposal is the first formative research exploring the mechanism of UI in women with CF and patient 
experiences and perceptions regarding UI and their treatment options. It will also be the first to assess 
feasibility and symptom improvement of nonsurgical treatment modalities for this population. As such, these 
are all important steps to 1) learn where to focus patient and provider education efforts and changes to the CF 
care model, 2) begin to understand what treatment may be preferred by and feasible for women with CF, and 
3) clarify the underlying cause of UI. Results will inform the content and design of a future multi-center, 
randomized trial aimed at determining the best option for nonsurgical treatment of UI (PFMT with bladder 
training, urethral support devices, or reusable absorbent products) in women with CF. Importantly, subjective 
and objective data will provide key data points to allow for power calculations of this trial and multiple patient 
feedback assessments will be utilized to determine feasibility of future trial. Utilization of patient consultants will 
provide additional input to ensure successful completion of aims and design of future trial. Given that a robust 
feasibility trial ensures a realistic assessment and capability to conduct the clinical trial16, we feel this proposal 
has the chance to innovate care of women with CF and UI. 
This interdisciplinary approach combines the expertise of the PI as a urogynecologist regarding evaluation 
and management of UI in women and the co-PI as a pulmonologist with an extensive expertise in women’s 
health and qualitative research in the CF population. The proposal also leverages the existing collaborative 
relationships between both the CF centers and the Urogynecology departments at the University of Pittsburgh 
and Johns Hopkins University. We seek to extend the expertise of healthcare providers caring for women with 
CF beyond their pulmonologist. By learning about treatment seeking preferences, goals of care, delineation of 
underlying UI physiology and treatment tolerability, we will be able to grant women’s health providers with the 
tools to care for women with CF and UI. Importantly, this is the beginning of a significant collaboration between 
providers with unique, relevant expertise that has the possibility of advancing the care and lives of women with 
CF. 
 
C. BACKGROUND AND SIGNIFICANCE  
Urinary Incontinence in Women - In women, UI is present in up to 37% of women age 20-39 years and “daily 
UI” is reported by up to 40% of women over age 60 years.17 In younger, nulligravid women without CF, the 
presence of UI is associated with lower psychological well-being.18 In general, UI is categorized as 1) stress 
urinary incontinence (SUI), related to effort or physical exertion including coughing, 2) urgency urinary 
incontinence (UUI), related to loss of urine associated with urgency, or 3) a combination of both, deemed 
mixed incontinence (MUI). 
 
Urinary Incontinence in Women with CF - With advancing treatments and management, the life expectancy of 
people with cystic fibrosis (CF) has increased to a median of 44.4 years according to the CF Foundation 2018 
Registry Report.1 As women with CF age, focus has shifted to previously overlooked aspects of care including 
sexual and reproductive health.2 UI, defined above as the complaint of involuntary loss of urine,3 is an 
understudied component of the lives of many women with CF. Previous work investigating incontinence in 
adult women with CF has reported a prevalence of 30-76% with associated impaired quality of life.4–6 Recent 
unpublished data from a large, multi-center survey of over 400 women with CF age 25 years and older has 
found that 49.8% of women have UI, with >13% experiencing daily symptoms. Activities such as coughing and 
airway clearance therapy (ACT) are reported as primary triggers, and, importantly, almost 40% of women 
report some degree of impact on their ability to effectively complete their chest physiotherapy.19 Importantly, 
the impact of highly effective modulator therapy (HEMT) on coughing and resultant UI is unknown. 
 
In the general population of women with UI, there has been extensive literature surrounding objective 
measurements for UI, ranging from complex, multi-channel urodynamics, which is an invasive procedure to 
measure a variety of values to describe UI parameters, to a non-instrumented cough stress test (CST), which 
is a non-invasive measure of objective SUI. Importantly, a positive CST has been shown to strongly correlate 
with subjective severity measures in the general population.20 Currently, there is no data on the correlation 
between subjective measures and objective, physical exam findings in women with CF and UI. Although it is 

 
P.I. ____Bradley, Megan_________________ 
CFF C-P&F –2020 
 
 
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reported that the majority of women with CF and UI experience stress leakage secondary to chronic cough and 
ACT,7,8 there has never been an objective investigation categorizing the type of UI experienced by women with 
CF.   Subjective and objective measures seem to be correlated in other populations,21 as we seek to 
streamline care for women with CF, additional investigation is necessary. Importantly, a better understanding 
of the prevalence of SUI in women with CF and subjective UI will aide in the trial design and power calculations 
for future investigations. 
 
  
Treatment modalities for UI  - Accepted non-surgical therapies for UI are behavioral therapies such as bladder 
training and PFMT9 or intravaginal mechanical devices for women with SUI.10 Although surgical options such 
as midurethal slings for SUI22 and intradetrusor onabotulinum toxinA (Botox) for UUI exist, guidelines 
recommend initial trials of conservative therapies.13  There are also newer absorbent products for UI that may 
be preferred over disposable pads.12 In the limited literature regarding treatment preference in women with UI, 
the individual experience of the population can significantly effect preferences for treatment. Some women may 
prioritize a risk-benefit balance while others may prioritize time commitment. Some women prefer utilization of 
web-based information and application based services while others prefer in-person contact with physicians.23–
25 Most qualitative studies focus on the experience of either women in the postpartum period26Very small 
studies have begun to investigate the improvement of symptoms in women with chronic lung conditions 
(including CF) after PFMT,14 but additional research surrounding other treatment modalities and larger studies 
are lacking. Currently, not enough is known about the characteristics of UI in women with CF, and this lack of 
data limits the ability of providers to make recommendations regarding treatment options.  
Feasibility studies can help determine whether an intervention should be recommended for efficacy 
testing.15 Given that we currently do not have enough understanding of treatment preferences, prevalence of 
objective stress urinary incontinence, tolerability of interventions or effect size of improvement after these 
modalities, a feasibility study is imperative to inform a future, definitive and adequately powered randomized 
controlled trial. 
 
D. Preliminary Results 
The co-investigator conducted an anonymous survey exploring self-reported general and CF-specific sexual 
and reproductive health concerns with adolescent and young adult women with CF ages 15-24 years from five 
U.S. CF centers.2 Questions included UI prevalence, age of onset, severity, triggers, and patient burden. 
Among the 188 participants (mean age 19.7±2.7 years), one out of six adolescent and young adult women with 
CF reported ever having experienced UI with a mean age of onset of 15.7±4.5 years. Only 15% of all 
participants reported ever discussing UI with their CF team with a mean age of first discussion of 16.0±2.7 
years. One-fifth of those reporting UI experienced symptoms more than once a day. Of those affected by UI, 
the top triggers reported were bad coughing fits (87%), laughing (40%), sneezing (27%), and any coughing 
(20%). One-third of those affected reported that UI sometimes prevented them from coughing effectively and 
performing full ACT sessions. UI was significantly associated with lower self-reported FEV1 (p<0.01). No 
significant association between UI and self-reported CF severity, BMI, CF-related diabetes, CF-related liver 
disease, or presence of a gastrostomy tube was found.  
 
In a similar ongoing survey of women with CF ages 25 years and older from 10 U.S. CF centers (currently, 
n=452, mean age 36.2 ±10.2 years),19 50% (n=224) have experienced UI with 83% reporting symptoms once a 
month or more. Of those affected by UI, the top triggers reported were bad coughing fits (87%), laughing 
(40%), sneezing (40%), physical activity (25%), any coughing (22%), and chest physiotherapy (17%). Nearly 
half of those affected (45%; 100/224) reported that UI sometimes or often prevented them from coughing 
effectively and performing full ACT. Twenty-seven percent never discussed UI with anyone and less than 30% 
of women with CF have spoken to their CF team about UI.27  Analysis of UI with self-reported CF outcomes is 
in progress.  
 
E. EXPERIMENTAL DESIGN AND METHODS  
Aim 1. Explore the experiences, attitudes, and knowledge of women with CF related to urinary 
incontinence and potential treatment modalities.  
 
Overview: Women with CF age 18 years and older who have experienced UI (n~30) will be recruited to 
participate in individual, semi-structured interviews. We have selected qualitative methodology to avoid 

 
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CFF C-P&F –2020 
 
 
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approaching the topic with preconceived theories or hypotheses.28 This will be the first study to explore the 
patient experience surrounding their care for UI. Based on prior research by the coinvestigator, we believe that 
women with CF will have significant bother from their UI but that, given the burden of their other disease-
related comorbidities, treatment preferences will be skewed towards options with low time commitment.  
 
Description of Participants and Participating Study Sites: Inclusion criteria: 1) Female age 18 years or older 2) 
Diagnosis of CF 3) Reports UI 4) Fluent in spoken English  
Recruitment sites: The Cystic Fibrosis Foundation’s Community Voice registry which is composed of more than 
1,100 members, including people with cystic fibrosis and their families.29 We will send out a call for subjects 
through our partnership with Community Voice to include women who report urinary incontinence. A letter of 
support is attached.  
Sample size: Determining sample size in qualitative research is a matter of judgment and experience in 
evaluating data collected guided by content saturation.30 For this project, we estimate the need for 
approximately 30 participants based on previous qualitative work of a similar nature.31 We will purposively 
sample a range of patient ages and previous pregnancy history (as pregnancy can influence incidence of UI) to 
gain a breadth of perspectives.  
 
Study Procedures: Participants will be recruited to participate in individual telephone interviews with the PI or a 
RC to understand their experiences and knowledge surrounding management of UI. The interview guide will be 
developed from existing work in other disease populations about similar themes18, 19, 26,27  and will explore 
participants’: a) experience with UI in daily life (and impact of HEMT on symptoms if applicable); b) care-
seeking decision making; c) knowledge of available treatment and management options; d) preferences for 
treatment including perspectives on acceptable clinical venue for screening and factors that may influence 
tolerability of treatment options; e) support needs and preferences (Table 1). Interviews will be audio-recorded 
and transcribed verbatim. All participants will receive compensation for their time. 
Table 1: Interview constructs and key questions18, 19, 26–31 
Constructs 
Key Interview Questions 
Urinary incontinence (UI) 
experiences 
• 
Tell me about your UI. 
• 
Tell me about the amount of UI you experience? 
• 
What activities tend to cause your UI? 
• 
How does your UI affect your daily life? 
• 
How has UI affected your CF? 
• 
[If applicable] Did HEMT change your experience with UI? 
• 
Did you ever seek treatment for your UI?  If so, tell me more about that. 
• 
What are ways that you alter your daily life due to your UI? 
Care-seeking decision 
making related to UI 
• 
Did you discuss your UI with anyone? 
• 
Did you ever discuss UI with your CF care team or another healthcare provider?  If so, tell me more 
about that. 
• 
What led you or would lead you to seek care or treatment for your UI? 
Knowledge of UI 
treatment modalities 
• 
Tell me what you know about the options for treating UI.   
• 
What do you know about physical therapy or pelvic floor muscle training (PFMT) to treat UI? 
• 
What do you know about other nonsurgical options to treat UI? (disposable pads, urethral support 
devices, absorbent products) 
• 
What do you know about surgical options to treat UI?  
• 
Where would you go to learn more about treatment options for UI?  
Preferences for UI 
treatment 
• 
In your opinion, what is the best way to identify women with CF who are experiencing UI?  
• 
Would you want to discuss UI with your CF team? Would you want to discuss UI with a women’s health 
provider? 
• 
What factors play into the choice of how to treat UI for women with CF? (time burden, effectiveness, 
invasiveness of therapy/procedure, comfort, ease, etc.) Which of these factors is most important to 
you?  
• 
Explain how need to go to weekly appointments for physical therapy would affect your life? What 
factors would play a role in decided to pursue this therapy? 
• 
What is your goal for treatment of your UI? 
• 
How much time would you want to commit to your treatment of UI? 
Support needs and 
preferences 
• 
What advice do you have for other women with CF who are experiencing UI? 
• 
What would you like to tell your CF team when telling them about supporting women with CF who are 
experiencing UI? 
• 
What do you expect from your CF team regarding discussions and support for you related to your UI? 

 
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CFF C-P&F –2020 
 
 
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Data Analysis: Transcripts will be analyzed through an iterative process of coding to identify themes. The 
principal investigator (PI) will develop an initial set of codes. Two coders will then independently review each 
transcript to apply the initial codebook and to identify additional codes using the NVivo qualitative analysis 
program. Using a consensus coding approach, after the first few transcripts are independently coded, the 
coders will meet to review their coding, discuss any discrepancies, and define any new codes; this will be 
repeated with subsequent transcripts using an iterative process until no new codes emerge. A senior co-
investigator will be available to adjudicate any differences in interpretation and review the codebooks. The final 
coding scheme will be applied to all transcripts and the investigative team will identify central themes on the UI 
patient experience and treatment knowledge and preferences of women with CF. Representative quotations 
will be selected to illustrate themes identified.  
 
Aim 2. – Evaluate the feasibility of a randomized controlled trial of non-surgical UI management 
options for women with CF.  
Overview: Nonsurgical therapies for UI include 1) behavioral training (e.g., bladder training, to teach one to 
gradually hold urine for longer periods), 2) PFMT to improve function of the pelvic musculature, and 3) urethral 
support devices.38 Additionally, newer reusable absorbent underwear have been used to decrease common 
issues with disposable pads such as vulvar irritation.12 To inform a larger trial, we propose a randomized, 
feasibility trial of a disposable urethral support device (Impressa®), Speax™ Reusable Underwear, or PFMT. 
As there is no current data on objective physical exam findings in women with CF and UI and, thus, limited 
evidence supporting the belief that this is SUI, all subjects will have a non-invasive pelvic exam to complete a 
non-instrumented cough stress test (CST) with a full bladder.39 Together, data on objective findings, baseline 
subjective bother on validated questionnaires, and improvement of symptoms will aid in power calculations for 
future, multi-center trial for treatment options in women with CF and UI. 
 
Description of Participants and Participating Study Sites: Inclusion criteria: 1) Female age 18 years or older 2) 
Diagnosis of CF 3) Self-reported UI (at least answer of “a little” on King’s Health Questionnaire – Question #2) 
4) Fluent in spoken English 5) Ability to present for in-office exam and study procedures  
 
Recruitment sites: Cystic Fibrosis Center (CF Center) at the 
University of Pittsburgh and the Johns Hopkins Cystic Fibrosis 
Center. These two sites have a current working relationship 
and also the capabilities for study procedures as discussed in 
facilities section. Study Procedures: Participants will be 
recruited at routine CF clinic visits and via telephone screening. 
Informed consent will be obtained before any study procedures 
are initiated. Baseline visit. Initial demographic questions and 
the King’s Health Questionnaire40 will be completed at the 
baseline visit. Subjects will be given materials to complete a 2-
day bladder diary.41 Participants will then have a pelvic exam 
for a visual urethral mobility examination42 and assessment of 
pelvic floor muscle strength.43 This exam will be completed by 
the urogynecology faculty at either site. We will first perform a bladder scan ultrasound to assess current 
bladder volume and then a cough stress test (CST). (Figure 1) The exam will be performed in the 
supine/lithotomy position with ≥300 mL of fluid in the bladder. We will have the subject cough forcefully 1-4 
times and the examiner will directly visualize the urethral meatus for the presence of leakage. Leakage of fluid 
from the urethral meatus coincident with/simultaneous to the cough(s) is considered a positive test consistent 
with SUI.  
Randomized feasibility trial (Table 2). At the baseline visit, women will be randomized to either a disposable 
urethral support device (Impressa®), Speax™ Reusable Underwear, or PFMT.  Randomization will be in a 
1:1:1 allocation stratified by site.  The disposable Impressa® urethral support is a tampon-like device that is 
available over the counter to help women with UI. Speax Reusable Underwear are similarly available for 
purchase online and are absorbent underwear for bladder leak protection. Urethral support device cohort - A 
week supply of the Impressa device will be provided and participants will be asked to complete a daily bladder 
• 
What resources would be helpful for you as a person with CF and UI? 

 
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CFF C-P&F –2020 
 
 
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diary for a total of 7 days. Reusable absorbent pad cohort – Two pairs of Speax underwear will be provided 
and subjects will complete a similar daily UI diary for 7 days. PFMT cohort - Experienced pelvic health physical 
therapists (at both University of Pittsburgh and at Johns Hopkins University) will complete two visits one week 
apart. We will develop a standardized pelvic floor exercise intervention based on previous RCT for PFMT in 
women with MUI.44 The intervention will comprise: 1) Bladder training and delayed voiding techniques 2) 
Urgency suppression 3) SUI strategies (e.g., ‘knack’) and 4) PFM training for those agreeable to internal 
exams.45 We were aware of the potential challenges for standardization of this type of intervention and 
ensuring consistency across multiple sites. We will limit the involvement to one experienced PT at each site 
and create a standardized protocol guided by both patient consultants, previous evidence, and expertise of 
Karen Von Berg, RT. Subjects will not be blinded to their group assignment given the nature of the differences 
in management options. At the end of the treatment assignment all subjects will repeat the KHQ and a patient 
global impression of improvement (PGI-I).  The PGI-I is a validated one question measure rating their urinary 
tract condition now, as compared with how it was prior to before beginning treatment on a scale from 1 (Very 
much better) to 7 (Very much worse).46  
Given the opportunity to gather acceptability on these options for a sensitive issue, subjects will be 
offered an option to further participate in one alternate therapy of their choosing. If they select this option we 
will organize an additional week of therapy and have them complete another PGI-I at the end of therapy.  
Acceptability and Feasibility assessment: Urethral support device cohort and Reusable absorbent pad cohort: 
Feasibility will be evaluated through assessment of use and product performance. Logs regarding utilization of 
assigned product will be completed daily. Patient treatment preference will be assessed after completion of 
both therapies utilizing the product performance questionnaire (PPQ).47  The PPQ is a 17-item product 
questionnaire that consists of product questions that are specific to incontinence products and includes 
questions about overall impression of product, ability to hold urine, ability to prevent odor, fit, discreteness, 
comfort when wet and dry, and ability to keep skin dry.47 PFMT cohort: Feasibility will be evaluated through 
assessment of adherence and self-reported success with ability to perform exercises. Adherence to 
intervention sessions will be documented by physical therapist using attendance logs. Adherence to home 
practice will be documented by participants in home logs that included the dates and times of practice. At the 
end of each physical therapy visit, participants will be asked to rate their confidence in performing the PFMT 
exercises featured in their program (extremely, very, moderately, somewhat, and not at all confident).  
 
At the end of the cohort, all participants will be asked to indicate how easy it would be to continue practicing 
their assignment intervention (extremely, very, moderately, somewhat, and not at all easy).48 All subjects will 
complete a Benefit, Satisfaction, and Willingness to Continue (BSW) questionnaire.49 We will consider therapy 
feasible (as measured by 80% adherence to treatment assignment over 7 days) and tolerable (as measured by 
patient report via questionnaire). By allowing subjects to choose another one of the arms after their 
randomization this will give us further, important information about feasibility and patient preference for a larger 
trial.  
 
Table 2: Study Flow 
 
Pre-
baseline 
visit 
Baseline Visit 
(in-person) 
Randomized Trial Period 
One week Cross-
Over Period 
(optional) 
End 
of 
Study 
 
 
 
D1 
D2 
D3 
D4 
D5 
D6 
D7 
 
 
Informed Consent 
x 
x 
 
 
 
 
 
 
 
 
 
KHQ 
 
x 
 
 
 
 
 
 
 
 
 
Bladder diary 
 
x 
x 
x 
x 
x 
x 
x 
x 
 
 
Cough Stress test 
 
x 
 
 
 
 
 
 
 
 
 
Randomization 
 
x 
 
 
 
 
 
 
 
 
 
PGI-I 
 
 
 
 
 
 
 
 
x 
 
x 
BSW 
 
 
 
 
 
 
 
 
x 
 
x 
Cohort Specific Measures 
 
 
 
 
 
 
 
 
 
 
 
Urethral support device 
Cohort 
 
 
 
 
 
 
 
 
 
x 
 
Reusable Underwear 
Cohort 
 
 
 
 
 
 
 
 
 
x 
 
Utilization log 
 
 
x 
x 
x 
x 
x 
x 
x 
 
 
PPQ 
 
 
x 
x 
x 
x 
x 
x 
x 
 
 
Physical Therapy Cohort 
 
 
 
 
 
 
 
 
 
x 
 
Physical Therapy Visit 
 
 
x 
 
 
 
 
 
x 
 
 

 
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CFF C-P&F –2020 
 
 
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Attendance Log 
 
 
x 
 
 
 
 
 
x 
 
 
Confidence scale 
 
 
x  
 
 
 
 
 
x 
 
 
KHQ, King’s Health Questionnaire; PGI-I, Patient Global Impression Improvement – Incontinence; PFMT, pelvic floor muscle therapy; 
PPQ, product performance questionnaire; BSW, Benefit, Satisfaction, and Willingness to Continue questionnaire 
  
Data analysis: Descriptive statistics will summarize feasibility survey measures and use log data with sample 
means and standard deviations calculated for continuous variables and sample proportions for categorical 
variables with 95% confidence intervals. Due to the pilot nature of this trial, our analytic strategy centers on 
calculation of point estimates and 95% confidence intervals of our feasibility measures as primary outcomes, 
rather than hypothesis testing. We will compare initial subjective scores of UI to objective measures utilizing 
correlation coefficients. To explore preliminary efficacy, PGI-I score will be compared between groups utilizing 
ANOVA and post-hoc testing. Paired t-test will be used to examine if there is statistically significant difference 
in the average KHQ scores between arms. The mean PPQ scores will be compared between the Impressa® 
urethral support and Speax™ underwear and mean BSW score will be compared between all groups.  For our 
randomized trial, we will recruit a total of 30 patients in order to have 80% power to detect at least a 10 point 
difference in total KHQ score with a significance level of 0.05 and assuming upwards of a 20% attrition rate for 
the study. Again, the feasibility trial is primarily designed to provide data to utilize for power calculations in 
future study designs. 
 
F. Limitations and Potential Pitfalls:  
Strengths of our study include the ability to quickly complete Aim 1 to allow for adequate time to complete Aim 
2. The main limitation of our study is the small sample size in Aim 2, but given the primary goal of assessing 
feasibility, these aims primarily serve to inform our larger trial design. Additionally, in view of the lack of 
available data, these will be important stepping stones to adequately power future studies. Although the lack of 
a control group could be seen as a limitation, there is such a vast body of literature surrounding prevalence 
and quality of life in pre-menopausal women with UI.50 Recruitment and retention of subjects can always pose 
a challenge. We will leverage the strong background of recruitment at our sites and the experience of our 
research coordinators to ensure adequate completion of aims. For Aim 1, we have a plan to recruit from 
Community Voice for aim 1 but can also recruit directly from participating centers. We have already 
communicated with Community Voice and have a letter of support included in our application. For Aim 2, we 
will start our feasibility trial by the end of year one of the grant period, so we are confident in our ability to 
complete our proposed aims in the study period. Additionally, the co-investigators Drs. Kazmerski and West 
are well-connected in the CF community and members of the CFF Women’s Health Research Working Group. 
Thus, we foresee minimal issues forming additional partnerships with another CF center (such as University of 
Texas-Southwestern, University of Washington, or National Jewish), if necessary. 
 
G. 
Consultant Arrangements: Ms. Lori Ferro and Ms. Joanna Conroy, both women with CF who have 
sought care for their experience with UI, will serve as a consultants on this grant. They will assist in study 
design, interview guide development, data analysis, and the writing and preparation of all manuscripts resulting 
from this research. In particular, they will provide a patient perspective, which is vital to this project. A Letter of 
Support is attached. 
 
H. TIMELINE 
 
 
Year 1 
Year 2 
 
Pre-
award 
Q1 
Q2 
Q3 
Q4 
Q1 
Q2 
Q3 
Q4 
IRB application and 
approval aim 1 
 
 
 
 
 
 
 
 
 
Protocol final aim 1 
 
 
 
 
 
 
 
 
 
Aim 1 “Qualitative 
Interviews” 
 
Recruit 
Participants 
 
 
Transcription and 
Data Analysis 
 
 
 
 
 
Complete Interviews 
 
 
 
 
Aim 2 “Randomized 
Feasibility Trial” 
 
 
Finalize protocol using data from 
Aim 1 
 
 
 
 
 
 
 
 
Recruit Participants 
 
 
 
 
 
 
 
Begin and Execute Trial 
Complete 
Trial 
 
 
 
 
 
 
 
 
Data analysis 

 
P.I. ____Bradley, Megan_________________ 
CFF C-P&F –2020 
 
 
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Manuscript 1: Qualitative 
Interviews 
 
 
 
 
Writing and submission 
 
 
Manuscript 2: Objective 
Exams and Questionnaires 
(from baseline visits) 
 
 
 
 
Writing and submission 
 
Manuscript 3: Randomized 
Feasibility Trial 
 
 
 
 
 
 
 
Writing and 
submission 
 
 
I. Literature Cited 
1. 
Fibrosis Foundation C. 2018 PATIENT REGISTRY ANNUAL DATA REPORT. 
 
2. 
Kazmerski TM, Prushinskaya O V., Hill K, et al. Sexual and Reproductive Health of Young Women 
With Cystic Fibrosis: A Concept Mapping Study. Academic Pediatrics. 2019;19(3):307-314. 
doi:10.1016/j.acap.2018.08.011 
 
3. 
D’Ancona C, Haylen B, Oelke M, et al. The International Continence Society (ICS) report on the 
terminology for adult male lower urinary tract and pelvic floor symptoms and dysfunction. Neurourology 
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