Clinical trial NCT05726318
Conditions: UTI
Sponsor: Megan Bradley
Start date: 2023-02-17; Completion date: 2024-08-02
Enrollment: 70 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
To evaluate the feasibility of recruiting eligible subjects into a randomized trial of a culture-directed versus empiric antibiotic strategy for patient-reported urinary tract infection symptoms in older women and the adherence to study procedures.

Detailed description:
To evaluate A) the feasibility of recruiting eligible subjects into a randomized trial of a culture-directed versus empiric antibiotic strategy for patient-reported urinary tract infection (UTI) symptoms in older women and B) the adherence to study procedures. We will recruit and enroll women with a history of recurrent UTI (rUTI) from the Women's Center for Bladder and Pelvic Health and the University of Pittsburgh's Clinical and Translational Science Institute (CTSI) Pitt+Me® Research Registry. Once enrolled and randomized, women will be followed for a total of 28 days to document both clinical resolution at day 7 from symptom onset and adverse events. H1) Enrolling a total of 70 subjects in \<1 year (at least 10% of eligible patients) will demonstrate feasibility of recruitment and H2) Documenting at least 70% patient compliance with study procedures will confirm patient adherence to study protocol. Exploratory Aim: To explore the safety of a culture-directed UTI treatment strategy and preliminary secondary outcomes of assigned treatments. H1) There will be an overall low number of adverse events and H2) Preliminary outcome data will help power future trial.

Arms: arm 1: Participants will be directed to refrain from taking antibiotics until results of urine culture are reported, which is expected within 48-72h. arm 2: Antibiotic Protocol. For participants in the empiric Rx arm, we will choose an antibiotic with consideration of patient reported allergies, current medications and current Infectious Disease Society of American (IDSA) guidelines. If there is a contraindication to the first antibiotic on the list they will progress to the next option until a suitable selection is achieved.
Interventions: intervention 1: Antibiotics
Intervention descriptions: intervention 1: Participants will be provided either nitrofurantoin 100 mg oral twice a day for 5 days, trimethoprim/sulfamethoxazole 875/125 oral twice a day for 3 days, fosfomycin 3g once oral, ciprofloxacin 250 mg oral twice a day for 5 days or cephalexin 500 mg oral twice a day for 5 days

Protocol documents:
Prot_SAP_000.pdf: 
NCT STUDY22060176, Document Date: 4/1/2025 
 
 
Study Protocol and Statistical Analysis Plan 
 
B. SIGNIFICANCE:    
B.1 Recurrent urinary tract infections in older women are common, poorly understood, and 
complicated by confounding symptom overlap.  
Urinary tract infection (UTI) is the most common bacterial infection, accounting for more than 8 million office 
visits and 1 million emergency department visits each year in the United States.2 Importantly, ~80% of visits for 
UTI are in women,32 and the highest rates of UTI recurrence occur in older women33 who also have more 
variation and antibiotic resistance in the uropathogens that cause UTIs.5,34 It is clear that menopause is a 
predominant risk factor for rUTI and that the pathophysiology of a single, sporadic UTI in premenopausal 
women is very different than that of rUTI in older women.8,35 In older women with patient reported UTI, given 
the symptom overlap between overactive bladder and genitourinary syndrome of menopause, the diagnosis of 
acute UTI should be made using a combination of symptom assessment and urine diagnostic studies.14,36 
Although dysuria seems to be the most discriminating symptom for a culture-positive UTI,37 we are still unable 
to reliably predict other factors that correlate with culture positivity and who will require antibiotics to clear a 
symptomatic UTI.38 Prospective investigations are crucial to improve our ability to predict those that may have 
symptom resolution without antibiotic therapy, but also those that can be safely managed with a urine culture-
directed antibiotic strategy.   
 
B.2. Preliminary observational data suggests that a urine culture-directed antibiotic strategy for patient 
reported UTI in older women is safe, but randomized controlled trials are needed to substantiate broad 
adoption of such a strategy.  
Non-antibiotic treatment and placebo as initial management of UTI symptoms have been evaluated in several 
randomized controlled trials (RCTs) that enroll a mostly premenopausal population.16,39–43 An initial non-
antibiotic strategy leads to a decrease in overall antibiotic use given either resolution of symptoms,18 or lack of 
bacteriuria.19 The results of these trials suggest that initial non-antibiotic management can be reasonable, but it 
may not be the method of choice for every woman with uncomplicated UTI. The literature on non-antibiotic 
treatment as initial management for UTI symptoms in older women is limited as the majority of studies did not 
enroll participants over the age of 65-70 and had a participant mean age of 30-40 years16,39–43 even though 
older women are an especially vulnerable population for drug interactions due to age-related physiologic 
changes and higher concomitant medication use.44 
 
Preliminary data: Recently, we performed a prospective cohort study on 152 women who were seeking care 
for UTI symptoms with mean age 66.4 (SD 14.9) of which 52.0% had a history of recurrent UTI. Women 
completed the UTI symptom assessment (UTISA) questionnaire45 before they submitted a culture and then 
were either placed on empiric antibiotics or managed expectantly based on provider and/or patient preference. 
After urine cultures were resulted, participants completed another UTISA questionnaire and the global rating of 
change (GRC). Our primary outcome was “symptom improvement” defined as reporting symptoms of “better” 
on the GRC questionnaire. 
 
Overall, 122 (80.3%) were managed expectantly, 
30 (19.7%) were managed with empiric antibiotics. 
The proportion of positive UCx in those treated 
empirically (53.3%) was similar to those 
managed expectantly (59%) (Table 1) which 
highlights the opportunity for antibiotic stewardship that could come from a culture-directed 
management strategy in older women with UTI symptoms. In the expectant management cohort, 78/122 
(63.9%) completed the follow-up questionnaires and 20 (25.6%) of those women reported symptom 
improvement. Importantly, 0/152 (0%) women were diagnosed with pyelonephritis or urosepsis in the 
30-days following their initial symptoms.46 Although this data begins to tell the story of the safety and 
efficacy of an expectant management approach for older women with UTI symptoms, there was inherent bias 
given the non-randomized nature of the cohort and no qualitative aims to understand the patient and provider 
perspective. There is still much we do not know regarding the ideal approach for an older woman presenting 
TABLE 1: Proportion of Culture Positivity in Prospective Cohort of 
Women with Patient Reported Urinary Tract Infection 
 
 
Empiric Antibiotics  
Positive 
Urine 
Culture 
 
Yes (n=30) 
No (n=122) 
Yes (n=88)  
16 (53.3%) 
72 (59.0%) 
No (n=64) 
14 (46.7%) 
50 (41.0%) 


NCT STUDY22060176, Document Date: 4/1/2025 
 
 
with UTI symptoms. A prospective, randomized trial of a urine culture-directed approach compared to an 
empiric-antibiotic strategy specifically in older women would be the first step towards an evidence-based 
algorithm taking subjective and objective factors into account.  
 
B.4. Qualitative studies find large discrepancies among patients regarding preference for management 
of UTI symptoms and poor understanding of UTI pathophysiology.  
Some qualitative studies, completed in younger women, suggest that they are aware and fearful of the adverse 
effects of antibiotics. They voice a need for physicians to modify management strategies to address these 
concerns and to devote more research efforts to improving nonantibiotic options for prevention and treatment 
of rUTIs, as well as management strategies that better empower patients.47 
 
Preliminary data (Bradley and Krishnamurti, unpublished).  We performed 30 semi-structured interviews 
with postmenopausal women (mean age 69.4 ±6.4 years) who have been previously treated for a UTI. 
Participants reported different variables that influenced their symptomatic UTI care-seeking decisions (Figure 
1). Two distinct “mental models” of preferred UTI treatment emerged.  
• 
One group reported greater anticipated risks related to antibiotic use (represented as yellow shaded 
nodes and red lines).  
• 
A separate group of women highly desired antibiotics for any presumed UTI. The desire for antibiotics 
was largely driven by concern for sequalae from non-treated bacteria (represented as green shaded 
nodes and green lines) and underweighting of potential side effects of antibiotic use.  
Both mental models demonstrate that the way women conceptualize their initial symptoms affect their 
preferences for antibiotic treatment and subsequent interventions and that we have a lot of work to do in to 
close the knowledge gap among women suffering with possible UTIs. We concluded that women’s cognitive 
approach to UTI symptoms and care-seeking is complex and influenced by many factors. These factors 
include both personal and friend/family experience, awareness of non-antibiotic management for presumed 
UTI and many misconceptions about urinary tract pathophysiology. An improved understanding of 
preconceptions and biases among patient and providers will aid in design of recruitment materials and 
study consent for a randomized trial of UTI management strategies. 


NCT STUDY22060176, Document Date: 4/1/2025 
 
 
 
B.5. Over recent years, qualitative research, drawing on the perspectives of both health-care 
professionals and patients, has improved our understanding of why clinical trials succeed. 
Qualitative research offers insight into the  discrepancies between patients’ viewpoints and evidence-based 
managment48 and can aid in the understanding of why many beneficial innovations diffuse slowly and 
unevenly, yet widely held superstitions remain immune to evidence.48 For the complicated issues surrounding 
bacteriuria in older women, our proposal allows for interviews with both patients, and providers, in order to 
delineate barriers experienced during recruitment for this pilot, randomized feasibility trial. This qualitative data 
will be imperative for the design of the definitive, larger trial.   
 
Given that many factors can affect the successful implementation and validity of intervention studies, a primary 
purpose of feasibility and pilot studies is to assess the potential for successful implementation of the main 
intervention and to reduce threats to the validity of these studies. The purpose of most feasibility and pilot 
studies should be to describe information and evidence related to the successful implementation and validity of 
a planned main trial.49 Such research has shown how lack of or unstable equipoise regarding trial interventions 
may affect health-care professionals’ engagement.50 Qualitative research has also highlighted how more 
pragmatic resource-related concerns (shortfalls) may undermine even committed health-care professionals’ 
support for trials. Research involving patients has provided further insight into the barriers to and facilitators of 
trial recruitment.51  
 
Our qualitative goals seek to determine  
• 
acceptability of the interventions to the users (patients and health-care provider)  
• 
ways to ensure representative recruitment and engagement 
• 
the willingness of patients to be randomized 


NCT STUDY22060176, Document Date: 4/1/2025 
 
 
• 
the willingness of clinicians to randomize patients and  
• 
variation in use or delivery of the intervention in each setting.52  
B.3. A pilot and feasibility trial is necessary prior to an adequately powered randomized controlled trial 
comparing urine culture-directed versus empiric antibiotic treatment of UTI symptoms in older women 
given the historical concerns of patients and providers. 
Regardless of age, the adverse effects of prescribing unindicated antibiotics are undesirable both on the 
patient level, because of potential side effects and drug interactions, and on the societal level because of its 
contribution to antimicrobial resistance. Limited data suggests that among women with bacteriuria, great care is 
needed to explain the rationale behind a delayed antibiotic strategy and to alleviate concerns over 
complications.23 Observational studies suggest primary care providers do overprescribe in those with 
advanced age, a history of recurrent UTIs,53 worsening urinary incontinence and those with altered mental 
status54–56 likely due to provider overcautiousness over concern of UTI sequalae.57 However, more recent, 
claims-based literature suggests that progression to systemic infection after initial uncomplicated UTI 
is very low in older women (ranging from 0.38-1.7%).26,58  
 
Preliminary data (Bradley and Zyczynski, unpublished). We recently investigated the knowledge, attitudes, 
and management practices of primary care providers (PCP) when treating older women with symptoms 
attributed to UTI. Among 142 PCPs, the majority of which were female (60.6%) and practiced in a suburban 
location (50.7%), only 26.1% felt it was safe to wait for a urine culture before prescribing antibiotics, 62.0% felt 
delaying antibiotics depended on multiple factors, and 9.2% felt it was never safe to delay antibiotics. We found 
that 33.1% prescribe empiric antibiotics in ≥50% of encounters, 27.7% of providers were concerned over 
progression of symptoms and 49.5% of providers were concerned for progression to sepsis. A higher 
proportion of providers practicing >15 years always felt safe delaying antibiotics compared to those with ≤15 
years of experience (33.3% v. 18.3%; p=0.04). This cross-sectional survey found that providers with more 
clinical experience have more comfort delaying antibiotics in older women with UTI symptoms, but 
despite recent literature suggestive of an overall low risk of urosepsis in this population,26 this sequela 
remains a significant concern among providers.  
 
This variability in antibiotic prescribing highlights the pressing need for level 1 evidence of the safety of a 
culture-directed approach to alleviate concerns among providers caring for older women. To update the current 
body of literature surrounding the natural progression of patient reported UTIs in ambulatory, community 
dwelling, older women, an initial randomized, feasibility trial of a urine culture-directed antibiotic approach in 
older women with patient reported UTI that includes standardized subjective and objective data is imperative. 
Data acquired from this pilot and feasibility study will provide us with important information regarding patient 
and provider willingness for enrollment, initial safety data and qualitative information that we can utilize to 
improve recruitment efficiency in a definitive trial.  
 
B.7. Summary/Strengths of the current proposal: 
• 
Significance: This proposal addresses a substantial gap in understanding the acceptability and safety of a 
urine culture directed antibiotic strategy for symptomatic older women with history of rUTI. The information 
gained in this feasibility study will lead to successful implementation of a randomized controlled trial and 
acquisition of Level I evidence – an imperative for the paradigm shift in current care of acute cystitis 
symptoms in older women with rUTI.    
 
• 
Experienced investigator and study team: Our strong team of investigators are well suited to conduct 
this clinical study. The PI and Co-Is have extensive experience in design and implementation of clinical 
trials as well as expertise statistics, qualitative research and in the evaluation and treatment of women with 
lower urinary tract disorders including rUTI.  The Co-I, Dr. Halina Zyczynski, has >20 years’ experience as 
PI in the NICHD Pelvic Floor Disorders Network and the NIDDK Urinary Incontinence Treatment Network. 
She will provide mentorship for study design, recruitment strategies and outcomes assessments to assure 
successful completion. The Co-I Dr. Leslie Meyn is well poised to serve as a statistician and Director of the 
Data Management Center (DMC) given her many years of experience working with basic, translational, and 


NCT STUDY22060176, Document Date: 4/1/2025 
 
 
clinical trial data focused on women’s health and reproductive infectious diseases. Dr. Tamar Krishnamurti 
is an expert in behavioral economics and social psychology, with a focus on decision making around risk 
and health outcomes. Her research on qualitative and mixed methods approaches to understanding 
decision making, with a specific focus on mental models related to risk will ensure completion of our 
qualitative aims. Finally, the PI, Dr. Megan Bradley, has a particular interest and expertise in older women 
suffering from UTIs with multiple recent publications and grants on this subject matter. Our seasoned 
clinical research staff have a demonstrated track record of success in patient recruitment and retention for 
our collaborative interdisciplinary research protocols.  Importantly, as a Division, we have been successful 
in recruitment for studies from multiple locations and our team is well poised to adhere to all study 
guidelines even with a large patient catchment area.  
 
• 
Strong Environment: The resources available at our institution will increase diversity of participants for 
both our pilot trial and our qualitative aims to allow for generalizability of results.  
o Our University of Pittsburgh Medical Center Women’s Center for Bladder and Pelvic Health 
(WCBPH) faculty are the sole providers of subspecialty FPMRS care in the UPMC Health System 
where we conduct 3,463 new evaluations for pelvic floor disorders annually. Our clinical program 
has conducted more new patient evaluations in 2021 than in 2019 due to a 40% increase in number 
of providers and office locations in the past 4 years. This reflects well on our reliability to enroll 
women from a large catchment area of north – southwestern PA.  Magee-Womens Hospital and the 
Department of Obstetrics, Gynecology and Reproductive Sciences have made a substantial 
commitment to providing care to disadvantaged communities at 3 inner city clinics, 7 rural, farming 
and mining community locations, including 5 that are >100 miles from Pittsburgh. The University of 
Pittsburgh also has made a commitment to addressing the racial disparities in health outcomes 
seen in the African American population.  
o The University of Pittsburgh’s Clinical and Translational Science Institute (CTSI) Pitt+Me 
Registry is a recruitment platform that uses ICD-9/10 diagnoses and demographics from the EHR 
along with participant-reported preferences to algorithmically match registry participants to increase 
socioeconomic, racial, and geographic representation in our study.  
o The CTSI Community PARTners Core Stakeholder Engagement Studios which helps engage 
community stakeholders in research will broaden the information gained from our qualitative 
participant aims.  
o Recruitment of providers from the WCBPH, the East POD of PCP offices of UPMC and the East 
Liberty Family Health Care Center which is a Federally Qualified Health Center (FQHC) with a 
focus to serve those that are uninsured, underinsured and underserved will increase generalizability 
of provider feedback.  
 
C. INNOVATION. Our proposed pilot study is innovative in several important ways. For our proposed pilot 
study, we have many innovative approaches including recruitment from the community through the CTSI 
Pitt+Me registry, utilization of electronic consents and completion of research visits/procedures remotely as 
participants desire. More importantly, the rationale of our pilot trial is to identify barriers to successful 
implementation, patient and provider concerns, and to develop recruitment material, data collection forms, 
databases and to establish preliminary safety data which are important for provider and patient engagement in 
a future RCT. This future trial will be inherently innovative as the first prospective randomized trial of culture-
directed versus empiric antibiotic therapy for subjective symptoms of UTI in a population of older women with a 
history of rUTI.  We have developed our aims to assess feasibility and guide methodology. Our proposed 
mixed methods approach will ascertain both quantitative and qualitative data.  Feasibility studies are extremely 
useful and necessary given the ability to detect unplanned difficulties with for example, the RCT design, 
recruitment strategies or the acceptability of the intervention.59 Importantly, our protocol lends itself to future 
studies in older women with sporadic UTI symptoms as they may be even less likely to have culture-proven 
disease.60 
 
D. APPROACH  


NCT STUDY22060176, Document Date: 4/1/2025 
 
 
D.1. Specific Aim 1: To evaluate A) the feasibility of recruiting eligible participants into a randomized 
trial of a culture-directed versus empiric antibiotic strategy for patient-reported UTI symptoms in older 
women and B) the adherence to study procedures. Exploratory Aim: To explore adverse events and 
clinical success between assigned treatments. 
D.1.1 Overview and Design. The proposed pilot study is designed as a culture-directed versus empiric 
antibiotic strategy for patient-reported UTI symptoms in older women. (Figure 2) Over 12 months, we will 
recruit 70 women with rUTI. Following enrollment, patients will be randomized in a 1:1 ratio to one of two 
groups. Patients assigned to the culture-directed arm will await results of urine culture prior to potentially 
receiving antibiotics and those assigned to the empiric arm will be prescribed immediate antibiotics from an 
established list of commonly prescribed antibiotics. Participants will be sent electronic questionnaires after 
urine culture results and then weekly for a total of 4 weeks.  The primary outcome is feasibility of trial defined 
as recruitment of 10% of eligible participants with 70% adherence to study protocol.   
 
D.1.2 Recruitment and Subject Eligibility. Women age 
≥65 years61 with diagnosis of recurrent UTI (rUTI) will be 
recruited from: 1) UPMC WCBPH faculty practices or 2) 
CTSI Pitt+Me Research Registry. Eligibility criteria are 
listed in Table 2.  
 
Rationale for Inclusion Criteria: We will include 
participants with patient reported recurrent UTI to allow 
for a pragmatic study design and generalizability. 
Additionally, our definition of patient reported UTI is like 
other RCTs evaluating non-antibiotic options as 
compared to antibiotic strategies for UTI treatment.43,62  
We will exclude participants with features of complicated 
UTI in the setting of structural or functional abnormalities 
or instrumentation /catheterization4,63 Eligibility is limited 
to female biologic sex given the differential risk profile of 
males and females who experience recurrent UTIs.  
 
D.1.3 Study procedures (Figure 2). 
D.1.3.1 – Screening and Enrollment Procedures. 
Information on the REDUCTION trial will be broadly 
disseminated in the University of Pittsburgh faculty 
practices at the WCBPH, through IRB approved 
brochures, social media ads, institutional (MWRI) and 
CTSI websites.  Interested women will be encouraged to contact the research staff for more information.  
Women who meet eligibility criteria after screening will be provided a consent form via their preferred method 
(electronic or paper).   
 
Importantly, the use of screening tests to assess whether prospective participants are appropriate candidates 
for inclusion in studies is an appropriate pre-entry activity. Per research guidelines, an investigator may discuss 
availability of studies and the possibility of entry into a study with a prospective participant without first 
obtaining consent when no clinical procedures performed solely for the purpose of determining eligibility for 
research are planned.64 Importantly, electronic approaches are becoming more widely used to obtain informed 
consent for research participation. Electronic consent (e-consent) provides an accessible and versatile 
approach to the consenting process, which can be enhanced with audio-visual and interactive features to 
improve participant engagement and comprehension of study procedures. E-consent may facilitate remotely 
conducted research by offering a feasible and robust alternative to face-to-face consenting approaches, 
however we will offer paper-based options, based on participant preference. 65–67 
 
D.1.3.2 Enrollment and Randomization (Day 0).  
• 
Upon development of symptoms (Figure 2), interested women will be scheduled for a baseline study 
visit (either in-person or virtual based on participant preference).  


NCT STUDY22060176, Document Date: 4/1/2025 
 
 
• 
This visit will first take place with a research coordinator where the participant will be allowed to ask any 
final questions about their consent which will then be signed either on paper or electronically.  
• 
Final eligibility will be determined by a licensed medical provider on the research team by ensuring the 
participant is not experiencing any symptoms of pyelonephritis and/or sepsis.  
• 
Consented study participants will then complete baseline questionnaires including the Urinary Tract 
Infection Symptom Assessment (UTISA)68 and the pelvic floor distress inventory short form (PFDI-20).69 
• 
Participants will submit a urine specimen for urine culture and urinalysis either in-person at one of our 
Women’s Center for Bladder and Pelvic Health faculty practices or a local laboratory  
 
Randomization: Participants will be randomized by the study team to either the “Culture-directed Antibiotic 
Treatment” or “Empiric (Immediate) Antibiotic Treatment” Group in a 1:1 allocation scheme, with randomization 
using permuted blocks of 4 or 6.   
 
D.1.3.3 Antibiotic Treatment Strategy. All participants will be allowed to use acetaminophen, non-steroidals, 
and/or phenazopyridine.  
Culture-directed Antibiotic Treatment: Participants will be directed to refrain from taking antibiotics until results 
of urine culture are reported, which is expected within 48-72h.  
Empiric Antibiotic Treatment Participants will be prescribed empiric antibiotics in accordance with our stepwise 
protocol below. 
 
Antibiotic Protocol. For participants in the empiric Rx arm, we will choose an antibiotic with consideration of 
patient reported allergies, current medications and current IDSA guidelines.70  If there is a contraindication to 
the first antibiotic on the list they will progress to the next option until a suitable selection is achieved.  
Antibiotic Protocol:  
1. Nitrofurantoin 100 mg PO BID x 5 days  
2. Trimethoprim/Sulfamethoxazole 875/125 mg PO BID x 5 days 
3. Fosfomycin 3 g once  
4. Cephalexin 500 QID x 5 days  
5. Ciprofloxacin 500 mg PO BID x 5 days 
 
D.1.3.4 Antibiotic management after urine culture results. All participants will be called with the results of 
their culture. Participants who register for MyUPMC, a no-cost, proprietary secure email service, will also 
receive the urine culture result by email. Cultures with result of “mixed flora” will be considered contaminated 
and be managed as negative.71   
 
Culture-directed Antibiotic Treatment.  
• 
Those with a negative urine culture will not be prescribed antibiotics and will be followed per protocol.  
• 
Those with a positive urine culture who report persistent UTI symptoms will be given antibiotics 
following the priority list above with consideration to reported antimicrobial sensitivities.  
• 
Those with a positive urine culture who report resolution of UTI symptoms will not be given antibiotic  
Empiric Antibiotic Treatment.  
• 
Those with a negative urine culture will be told to stop antibiotics 
• 
Those with a positive urine culture sensitive to the empiric antibiotic will be instructed to complete the 
full course of their antibiotics 
• 
Those with a positive culture resistant to empiric antibiotic will be given an alternative antibiotic per 
antibiotic protocol and will be followed per protocol. If there are no oral antibiotic options with patient-
specific and antimicrobial sensitivities, we will engage local infectious disease physicians for 
management as per standard clinical protocols. 
 
D.1.6. Study follow-up assessments.   
All participants will be followed with electronic surveys via Research Electronic Data Capture (REDCap) 
software, which is a browser-based, metadata-directed EDC software and workflow methodology for designing 


NCT STUDY22060176, Document Date: 4/1/2025 
 
 
clinical and translational research databases,72 on day 2-3 (after result of urine culture). To avoid limiting 
enrollment to only those with access to technology, our research coordinator can also call and administer the 
questionnaire by phone to ensure ability to access and complete electronic materials. Follow-up assessments 
will be completed weekly for a total of 4 weeks. These will include UTISA questionnaire,68 antibiotic associated 
side effects, use of other symptom mitigating remedies, and adherence to assigned study arm.  
 
Participants will be provided with a clinical line to call 24/7 with report of worsening symptoms which will be 
discussed with the PI, Dr. Bradley for determination of antibiotic prescription and if participants report fevers or 
chills this will prompt an in-person evaluation in clinic during business hours or the emergency department after 
hours. If participants call to report new symptoms during the study course, a repeat urine culture will be 
obtained.73 Given that these episodes could be considered either a recurrent or incompletely treated infection 
we plan to manage these per clinical care and not based on the participants initial study arm.  
 
 
 
D.1.7. Data analysis.  
Specific aim 1A) To evaluate the feasibility of recruiting eligible participants into a randomized trial of a 
culture-directed versus empiric antibiotic strategy for patient-reported UTI symptoms in older women.  
All outcomes for the feasibility assessment will be descriptive using numbers and proportions of patients and 
95% CIs. We will report the number of patients assessed for eligibility along with the numbers excluded based 
on not meeting inclusion criteria, participation declined, and other reasons.74 We will document number and 
proportion of enrolled participants who were randomized along with the number/proportion who received their 


NCT STUDY22060176, Document Date: 4/1/2025 
 
 
allocated assignment. We will document those lost-to follow-up including potential reasons.  These data will 
provide information on the feasibility of recruiting patients into a future, large randomized, placebo controlled 
clinical trial. We believe that successfully recruiting 10% of eligible patients (e.g., 6-7 patients per month) will 
confirm the capacity to recruit for a future trial.  
 
Power calculation:75,76 The primary outcome is feasibility which we will define as the ability to recruit 10% of 
eligible patients. As this is a pilot study, the sample size of 70 patients was determined based on clinical and 
logistical resources rather than statistical requirements for hypothesis testing. We anticipate screening 
approximately 1200 potentially eligible patients (based on known clinical data from our practice and current 
enrollment of women with recurrent UTI in Pitt+Me) during the 12 months of recruitment (~100 per month) of 
which at least 800 will be deemed eligible and have UTI symptoms. (~67 per month) This is based on data 
from our group on urine cultures sent annually and time between UTI episodes.35 A 95% confidence interval 
(CI) for the recruitment rate provides a 2.4% margin of error (MoE) assuming the true rate is 10%.  
 
Specific aim 1B) To evaluate participant adherence to study procedures.  
For a larger trial, electronic surveys may significantly reduce research coordinator burden. To evaluate 
feasibility of this approach we will administer electronic surveys through Research Electronic Data Capture 
(REDCap) software.72 Surveys are sent via email and can be accessed through either a laptop, desktop or 
smart phone. Participants will also be called at day 2-3 (after urine culture results) and then weekly to assess 
issues with electronic materials. We will evaluate proportion of those with electronic success and investigate 
demographic variables that may be associated with inability to utilize electronic materials. To assess patient 
adherence to study procedures, defined as completion of all follow-up questionnaires, we will describe the 
percentage of enrollees who completed 100% of study procedures, 80% to 100% of study procedures and 
50% to 80% of study procedure. A priori, we believe that compliance with 70% of study procedures will 
demonstrate satisfactory patient adherence to protocol.  If the underlying adherence rate is 70%, a sample size 
of 70 provides a 10.1% MoE. 
 
Exploratory Aim: To explore the safety of a culture-directed UTI treatment strategy and preliminary 
secondary outcomes of assigned treatments.  
Safety Aims62 
1. Adverse events per group (most likely antibiotic side effects (i.e., gastrointestinal distress, antibiotic 
related diarrhea, rash) between groups.  
2. Serious adverse events per group (defined in line with FDA reporting guidelines as a medical event that 
does one or more of the following: results in death, is life‐threatening, requires inpatient hospitalization 
or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, or is a 
congenital anomaly/birth defect.77 
Analysis. We anticipate that adverse events will be reported relatively infrequent.78 All outcomes will be 
described using numbers and proportions of patients. Proportions between groups will be compared with either 
chi-square or Fischer’s exact testing. 
Secondary exploratory aims.   
Proportion of those with clinical cure (as 2 or less points (slight, very slight, or no problems) on all five 
components of the UTISA (ref) at day 14 (future trial primary outcome) 
 
Analysis. All outcomes will be described using numbers and proportions of patients or means with confidence 
intervals. Proportions between groups will be compared with either chi-square or Fischer’s exact testing and 
means will be compared with student’s t-testing. Exploratory logistic regression modeling will be utilized to 
investigate the odds of both initial treatment failure and/or recurrent of UTI symptoms between groups and 
based on baseline characteristics 
 
Power analysis:76,79 As above, we propose a future trial with a primary outcome to be symptom resolution at 
day 14 defined as 2 or less points (slight, very slight, or no problems) on all five components of the UTI 
symptom assessment (UTISA).43,78  The literature suggests 58-80% of women receiving empiric antibiotics for 
patient reported UTI will achieve clinical cure by day 3-7 after treatment initiation. 43,78Given that only women 


NCT STUDY22060176, Document Date: 4/1/2025 
 
 
with a positive urine culture will be given culture-directed antibiotics, and women in the empiric arm may have 
to have their antibiotics changed or stopped at the time of culture result, we anticipate a higher proportion of 
those in the culture-directed arm to have symptom resolution at day 7. Assuming 70% symptom resolution in 
the empiric arm, a future trial of 262 participants, with 131 per arm, would have 80% power to detect a 15-
percentage point difference between groups with a 2-sided alpha of 0.05, while a sample size of 300 would be 
required assuming 65% resolution. Therefore, we believe that successfully recruiting a total of 70 participants 
at a rate of 6-7 participants/month will confirm the feasibility of future trial completion in <4 years (equivalent to 
other trials of antibiotic regimens for symptomatic UTI).17,78 
 
 
Statistical methods 
Primary Outcomes 
Statistical analysis 
Feasibility: 
- 
Number of subjects that were screened for 
participation 
- 
Number and proportion of subjects screened 
who met inclusion/exclusion criteria  
- 
Number and proportion of subjects who 
either declined participation or were ineligible 
(including reasons for ineligibility) 
- 
Number and proportion of eligible subjects 
that were enrolled in the study 
- 
Number and proportion of subjects enrolled 
who completed the study 
- 
Monthly enrollment rate 
 
Descriptive analysis = counts and proportions or 
means with standard deviation 
 
Adherence: 
- 
Number of those that completed all study 
procedures 
- 
Number of subjects that took alternative 
agents taken by subjects for management 
of symptoms  
- 
Number of subjects in the culture-directed 
arm that acquired off-protocol antibiotics for 
their symptoms 
- 
Number of subjects able to complete 
electronic surveys 
 
Descriptive analysis = counts and proportions  
 
Secondary Outcome  
 
Proposed primary outcome for future trial (  Clinical 
Success at 14 days UTISA 1-3,5<=1) 
Descriptive analysis = counts and proportions  
 
Comparative = Chi-square 
 
 
 

ICF_001.pdf: 
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University of Pittsburgh
Department of OB/GYN 
300 Halket Street
Pittsburgh, PA 15213
CONSENT TO ACT AS A PARTICIPANT IN A RESEARCH STUDY
TITLE:  A Randomized Pilot and Feasibility Study of a cultuRE-Directed approach to Urinary traCT Infection 
symptoms in Older womeN: a mixed methods evaluation – the REDUCTION trial
PRINCIPAL INVESTIGATOR:  
Megan Bradley, MD
Department of Obstetrics, Gynecology and Reproductive Sciences
Division of Urogynecology and Pelvic Reconstructive Surgery
Magee-Womens Hospital
412-641-7850
STUDY COORDINATOR:
Lindsey Baranski, BA
Judy Gruss RN
412-641-6881
KEY INFORMATION SUMMARY
You are being asked to participate in a research study, which is completely voluntary. The study’s team members 
will explain the details of the study and answer any questions you have regarding the study. This study focuses 
on two different ways to manage urinary tract infection symptoms in older women. Duration of involvement in 
this study is for 4 weeks and there will be 70 enrolled. If you participate in the study you will be assigned randomly 
to either watch your symptoms until urine testing comes back or start an antibiotic early. The study team is testing 
your symptoms at the time they start, when your urine testing comes back and then weekly for 4 weeks after 
symptoms. Please be reassured that you will receive antibiotics if they are necessary regardless of your assignment 
in the study. The first research encounter can either be done remotely or in-person based on your preference. You 
will be asked to complete some questionnaires at each of these time-points. We will make every attempt to protect 
your privacy and the confidentiality of your records, as described in this document, but cannot guarantee the 
confidentiality of your research records, including information obtained from your medical records, once your 
personal information is disclosed to others outside UPMC or the University. There is no direct benefit to you for 
participant in the study. However, this study will help providers to better understand the pros and cons of early 
antibiotics for urinary tract infection symptoms. If you decide not to participate in this study, you will continue 
to receive clinical care from your provider as you have planned together.
Why is this study being done?


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This is a research study to evaluate the pros and cons of early antibiotics for urinary tract infection symptoms in 
older women. Currently, it is unknown who really needs antibiotics for management of urinary tract infection 
symptoms. 
Studies in women who do not receive antibiotics for urinary tract infection symptoms show that up to 50% will 
improve without antibiotics and that it is a generally safe approach. This study will help to improve our 
understanding of how women do with either early antibiotics or only antibiotics if needed after urine testing for 
urinary tract infection symptoms. 
Who is being asked to take part in this study?
Approximately 70 women from both the University of Pittsburgh Medical Center (UPMC) and through the 
Pitt+Me research registry who are at least 65 years old and have a history of recurrent urinary tract infections  will 
be enrolled in this study. 
Women are being asked to enroll even if they do not currently have symptoms of a UTI and that when symptoms 
begin, the participant should contact the study team
What is the duration of participation in this study?
If you agree to participate and are eligible, your participation will be requested for 4 weeks after urinary tract 
infection symptoms start. 
What are the procedures of this study?
1.
If you agree to participate in this research study, you will complete a baseline assessment, which will be 
within 24 hours of when you call with urinary tract infection symptoms. This visit can be done either remotely 
or in person. This is encounter #1.
2.
Before in-person appointments: Investigators will take appropriate measures to ensure that research 
subjects are not displaying symptoms or have been in known contact with COVID-19 before their participation 
in research. We will ask participants to wear a mask to the appointment if they have one. 
3.
Before remote sessions: Prior to videoconferencing assessments, study staff will help participants set up 
for  sessions using their own device such as a laptop, iPad, etc., 
4.
During eencounter #1, you will complete questionnaires and be asked to provider a urine sample (either 
on site for in-person visit or to a local lab if you have your visit completed remotely). 
Questionnaires: You will be asked to complete some questionnaires that you will fill out on your own.  These will 
take approximately 20-25 minutes to complete.  Questions will be answered either on paper or a computer.
Urinary Tract Infection Symptom Assessment: A set of measures that ask about current urinary tract infection 
symptoms. This will take approximately 5 minutes.
Pelvic Floor Distress Inventory Scale: A set of measures that ask about urinary, fecal and other pelvic floor 
symptoms. This screen takes approximately 5 minutes to complete.  
Interview/Chart Review: Study staff will record research data from your medical record. All of this information 
was collected as part of previous clinical visits with your doctor. Study staff will simply record some of this 
information on study forms (that do not contain your name or other identifying information). Things that they 
will record include your age, race, ethnicity, body mass index, current medications, smoking status, education 
level, medical and surgical history, and information about your gynecology history.  During your study visit, a 
member of the research staff will conduct an interview to verify this information. This will take approximately 
10 minutes.


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At the end of encounter #1, you will be updated on when to expect questionnaires to be sent and have study staff 
call you which will take place at week 1, 2, and 3 after your baseline visit. 
5.
You will then be randomized (like the flip of a coin) to either receive antibiotics that day or wait until your 
urine culture results return. All participants will be allowed to use acetaminophen, non-steroidals, and/or 
phenazopyridine (also known as Azo which is an over the counter agent for UTIs). If you are in the early 
antibiotic group, we will choose an antibiotic with consideration of patient reported allergies, current 
medications and current guidelines. All antibiotics are FDA approved for treatment of urinary tract infection. 
If there is a contraindication to the first antibiotic on the list below we will progress to the next option until a 
suitable selection is achieved.
-
Nitrofurantoin orally twice a day for 5 days
-
Trimethoprim/Sulfamethoxazole orally twice a day for 3 days
-
Fosfomycin orally once
-
Cephalexin orally twice a day for 5 days
-
Ciprofloxacin orally twice a day
6.
Once your urine culture results return (which usually takes 2-3 days) we will either start an antibiotic if 
you were in the “wait for testing” group and your urine culture is positive or we will stop the antibiotics in 
those already on them for a negative urine culture. 
Encounters #2/#3/#4: Questionnaires and Side Effects
The Urinary Tract Infection Symptom Questionnaire and a series of questions about potential medication side 
effects will be sent to you via email. A study team member will also call you to make sure that you were able to 
complete these questionnaires on the computer. If you have issues with the electronic format you can complete 
the questions over the phone. 
All participants will complete the questionnaires, including those who start antibiotics, those who stop antibiotics, 
and those who were randomized to the “wait for testing” group and received a negative urine culture result.
What are the possible risks and discomforts of this study?
Recording information from your medical record: There is the small chance of loss of confidentiality of your 
medical information. We take great care to minimize this chance by not recording your personal information (like 
your name) on forms and keeping our records in a locked office and in a password protected data server.
Questionnaires: You may feel embarrassed answering some of the questions or the questionnaires may cause 
distress. Although we encourage you to answer all of them, you may skip those which make you feel 
uncomfortable.
Antibiotic side effects: You may experience side effects from your antibiotics prescribed either at the beginning 
of symptoms or after your urine testing returns. Antibiotic side effects may consist of an allergic reaction, upset 
stomach, diarrhea, or rash.
Worsening of urinary tract symptoms: This could occur in those who receive early antibiotics or also in those who 
are waiting for urinary results. For those who wait for urinary results before starting antibiotics, an infrequent risk 
is that the infection may increase in severity, which may result in hospitalization or inflammation of the kidneys. 
Importantly, this is a risk to anyone who is experiencing a urinary tract infection. The study team will be available 
for you to call and discuss at any time. You will also be allowed to take non-prescription medications for your 
symptoms as you desire (like ibuprofen). 


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As with any experimental procedure, there may be adverse events or side effects that are currently unknown and 
some of these unknown risks could be permanent, severe or life-threatening
You may call 412-641-7850 or 412-641-6881 24/7 to talk to a member of our research team.
Will I benefit from taking part in this study?
You may not experience any direct benefit from being a participant in this study.  However, the information we 
gain from this study will give us an understanding of the preferred option to manage women with urinary tract 
infection symptoms. 
You will be provided with the results from your urine culture and the management of this will be based on the 
results, your symptoms the clinical judgement of the clinical team. 
Will anyone know that I am taking part in this study?
All records pertaining to your involvement in this study are kept strictly confidential (private) and any data that 
includes your identity will be stored in locked files. Your identity will not be revealed in any description or 
publications of this research. If medical records are shared they will be de-identified. Safeguards will be used to 
minimize breach of confidentiality.  This will include labeling all data with a study number rather than your name 
or other direct identified.  
What treatments or procedures are available if I decide not to take part in this research study?
You do not have to participate in this study. You will continue to receive all typical care provided to women with 
urinary tract infections. 
If I agree to take part in this research study, will I be told of any new risks that may be found during the 
course of the study?
You will be promptly notified if, during the conduct of this research study, any new information develops which 
may cause you to change your mind about continuing to participate.
Will my insurance provider or I be charged for the costs of any procedures performed as part of this research 
study?
You and/or your insurance will be charged, in the standard manner, for any urinary tests that are ordered or 
antibiotics that are prescribed along with medical visits for your routine medical care. This includes any visits to 
your doctor for your medical care. You will be responsible for any co-pays, coinsurances, or deductibles 
associated with your clinical visits. The proposed antibiotics have different costs associated with each, but that 
the cost of the antibiotic will not be considered when prescribing the antibiotic.
Neither you, nor your insurance provider, will be charged for the costs of any of the procedures performed for the 
purpose of the research study. These procedures include medical record abstraction and study questionnaires.
Will I be paid if I take part in this research study?
You will be paid $50 (Vincent card) at the completion of the 4-weeks and additionally, we will provide one free 
parking voucher if you chose to have your first visit at Magee Women’s Hospital.
All compensation is taxable income to the participant regardless of the amount.  If a participant receives $600 or 
more in a calendar year from one organization, that organization is required by law to file a Form 1099 – 
Miscellaneous with the IRS and provide a copy to the taxpayer. Individuals who do not provide a social security 
number may still participate in the research, but the IRS requires that 26% of the payment be sent by the institution 
to the IRS for ‘backup withholding;’ thus you would only receive 74% of the expected payment. 


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Your data used in this research study may contribute to a new discovery or treatment.  In some instances, these 
discoveries or treatments may be of commercial value and may be sold, patented, or licensed by the investigators 
and the University of Pittsburgh for use in other research or the development of new products.  You will not retain 
any property rights nor will you share in any money that the investigators, the University of Pittsburgh, or their 
agents may realize.
Who will pay if I am injured as a result of taking part in this study?
University of Pittsburgh researchers and their associates who provide services at the University of Pittsburgh 
Medical Center (UPMC) recognize the importance of your voluntary participation in their research studies.  These 
individuals and their staff will make reasonable efforts to minimize, control, and treat any injuries that may arise 
as a result of this research.  If you believe that the research procedures have resulted in an injury to you, 
immediately contact Dr. Bradley at the number listed on the first page. Emergency medical treatment for injuries 
solely and directly related to your participation in this research study will be provided to you by the hospitals of 
UPMC. Your insurance provider may be billed for the costs of this emergency treatment, but none of those costs 
will be charged directly to you. If your research-related injury requires medical care beyond this emergency 
treatment, you will be responsible for the costs of this follow-up care. At this time, there is no plan for any 
additional financial compensation.
Will this research study involve the use or disclosure of my identifiable medical information?
This research study will involve the recording of current and/or future identifiable medical information from your 
hospital and/or other health care provider (for example, your physician’s office records).  This information that 
will be recorded will be limited to information concerning your urinary tract infection history and/or current 
symptoms (for example, diagnostic information, lab and scanned results, medications, medical history).  This 
information will be used to determine your eligibility for this study and to follow your response once you are 
enrolled in the study. Research data will not be placed in your medical record, but your urine culture from the 
study (which is ordered as part of your clinical care) will be available. The medical record will be available to the 
research team of investigators indefinitely. 
Who will have access to identifiable information related to my participation in this research study?
In addition to the investigators listed on the first page of this authorization (consent) form and their research staff, 
the following individuals will or may have access to identifiable information (which may include your identifiable 
medical information) related to your participation in this research study: 
Authorized representatives of the UPMC hospitals or other affiliated health care providers may have access to 
identifiable information (which may include your identifiable medical information) related to your participation 
in this research study for the purpose of  internal hospital operations (i.e. quality assurance).
Authorized representatives of the University of Pittsburgh’s Office of Research Protections may review your 
identifiable research information (which may include your identifiable medical information) for the purpose of 
monitoring the appropriate conduct of this research study. In unusual cases, the investigators may be required to 
release identifiable information (which may include your identifiable medical information) related to your 
participation in this research study in response to an order from a court of law.  If the investigators learn that you 
or someone with whom you are involved is in serious danger or potential harm, they will need to inform, as 
required by Pennsylvania law, the appropriate agencies.
Your data may be used for future research or shared with other investigators; however, the information will be 
used or shared in a de-identified manner.


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Your information collected as a part of this research, after removal of identifiers, could be used for future research 
studies or distributed to another investigator for future research studies without additional informed consent.
For how long will the investigators be permitted to use and disclose identifiable information related to my 
participation in this research study?
The investigators may continue to use and disclose, for the purposes described above, identifiable information 
(which may include your identifiable medical information) related to your participation in this research study for 
a minimum of seven years after final reporting or publication of a project. 
Is my participation in this research study voluntary?
Your participation in this research study, to include the use and disclosure of your identifiable information for the 
purposes described above, is completely voluntary.  (Note, however, that if you do not provide your consent for 
the use and disclosure of your identifiable information for the purposes described above, you will not be allowed 
to participate in the research study.)  Whether or not you provide your consent for participation in this research 
study will have no effect on your current or future relationship with the University of Pittsburgh.  Whether or not 
you provide your consent for participation in this research study will have no effect on your current or future 
medical care at a UPMC hospital or affiliated health care provider or your current or future relationship with a 
health care insurance provider.
Your doctor may be involved as an investigator in this research study.  As both your doctor and a research 
investigator, s/he is interested both in your medical care and the conduct of this research study.  Before agreeing 
to participate in this research study, or at any time during your study participation, you may discuss your care 
with another doctor who is not associated with this research study.  You are not under any obligation to participate 
in any research study offered by your doctor.
May I withdraw, at a future date, my consent for participation in this research study?
You may withdraw, at any time, your consent for participation in this research study, to include the use and 
disclosure of your identifiable information for the purposes described above.  (Note, however, that if you 
withdraw your consent for the use and disclosure of your identifiable medical record information for the purposes 
described above, you will also be withdrawn, in general, from further participation in this research study.)  Any 
identifiable research or medical information recorded for, or resulting from, your participation in this research 
study prior to the date that you formally withdrew your consent may continue to be used and disclosed by the 
investigators for the purposes described above.
To formally withdraw your consent for participation in this research study you should provide a written and dated 
notice of this decision to the principal investigator of this research study at the address listed on the first page of 
this form.
Your decision to withdraw your consent for participation in this research study will have no effect on your current 
or future medical care at a UPMC hospital or affiliated health care provider or your current or future relationship 
with a health care insurance provider.
If you withdraw from the study and you would still prefer to be seen by our clinical team for your urinary tract 
infection symptoms then we will provide you with the information to set up an appointment as per clinical care.
What other information is relevant to participation in this study?


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A description of this clinical trial will be available on http://www.clinicaltrials.gov, as required by US Law.  This 
website will not include information that can identify you. At most, the website will include a summary of the 
results. You can search this website at any time
This research is covered by a Certificate of Confidentiality from the National Institutes of Health. This means that 
the researchers cannot release or use information, documents, or samples that may identify you in any action or 
suit unless you say it is okay. They also cannot provide them as evidence unless you have agreed.  This protection 
includes federal, state, or local civil, criminal, administrative, legislative, or other proceedings. An example would 
be a court subpoena. 
There are some important things that you need to know.  The Certificate DOES NOT stop reporting that federal, 
state or local laws require. Some examples are laws that require reporting of child or elder abuse, some 
communicable diseases, and threats to harm yourself or others.  The Certificate CANNOT BE USED to stop a 
sponsoring United States federal or state government agency from checking records or evaluating programs. The 
Certificate DOES NOT stop disclosures required by the federal Food and Drug Administration (FDA).  The 
Certificate also DOES NOT prevent your information from being used for other research if allowed by federal 
regulations. 
Researchers may release information about you when you say it is okay. For example, you may give them 
permission to release information to insurers, medical providers or any other persons not connected with the 
research.  The Certificate of Confidentiality does not stop you from willingly releasing information about your 
involvement in this research. It also does not prevent you from having access to your own information. 
Voluntary Consent 
The above information has been explained to me and all of my current questions have been
answered. I understand that I am encouraged to ask questions about any aspect of this
research study during the course of this study, and that such future questions will be answered
by a qualified individual or by the investigator(s) listed on the first page of this consent document
at the telephone number(s) given. I understand that I may always request that my questions,
concerns or complaints be addressed by a listed investigator.
I understand that I may always contact the Human Subjects Protection Advocate of the IRB Office, University of 
Pittsburgh (1-866-212-2668) to discuss problems, concerns, and questions; obtain information; offer input; or 
discuss situations in the event that the research team is unavailable.
By signing this form, I agree to participate in this research study and authorize Dr. Bradley and her team to access 
my medical records for the purposes described in this form. A copy of this consent form will be given to me.
_______________________________
_______________________________
        
Participant’s signature
Printed name of Participant
        
_________
Date


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Certification of Informed Consent
I certify that I have explained the nature and purpose of this research study to the above-named individual(s), and 
I have discussed the potential benefits and possible risks of study participation. Any questions the individual(s) 
have about this study have been answered and we will always be available to address future questions as they 
arise. I further certify that no research component of this protocol was begun until after this consent form was 
signed. 
__________________________________
_______________________
Printed Name of Person Obtaining Consent
Role in Research Study
_
_________________________________
__________
Signature of Person Obtaining Consent
Date