The Predictive Value of Ureteral Jet Assessment With Ultrasound in Patients Presenting With Acute Renal Colic
Phase: NA
Conditions: Ureteral Calculi
Sponsor: Washington University School of Medicine

Desai 
Urojet study v. 3.0 
Page 1 of 12 
08 August 2016 
 
 
The Predictive Value of Ureteral Jet Assessment with Ultrasound in Patients 
Presenting with Acute Renal Colic  
 
 
 
 
 
Washington University School of Medicine 
Department of Surgery 
660 S. Euclid Ave., Campus Box 8109 
St. Louis, MO 63110 
 
 
 
Protocol v. 3.0 
Version date: August 08, 2016 
 
 
 
Principal Investigator: 
Alana C. Desai, M.D. 
Phone:  
 
 
(314) 454-5999 
Email:  
 
 
desaia@wudosis.wustl.edu 
 
 
Co-Investigators: 
 
Kathryn Robinson, M.D. 
 
 
 
 
Daniel Theodoro, M.D. 
 
 
 
 
 
 
 

Desai 
Urojet study v. 3.0 
Page 2 of 12 
08 August 2016 
 
 
Ureteral jet assessment for the assessment and prognostication of ureteral stones 
 
1.0 
BACKGROUND AND RATIONALE ............................................................................................. 3 
2.0 
OBJECTIVES ................................................................................................................................... 4 
3.0 
PATIENT SELECTION ................................................................................................................... 4 
4.0 
REGISTRATION PROCEDURES................................................................................................... 5 
5.0 
STUDY PLAN .................................................................................................................................. 5 
6.0 
DATA AND SAFETY MONITORING ........................................................................................... 8 
7.0 
STATISTICAL CONSIDERATIONS .............................................................................................. 8 
8.0 
REFERENCES ............................................................................................................................... 11 
APPENDIX A: Study Schedule of Events .............................................................................................. 12 
 
 
 

Desai 
Urojet study v. 3.0 
Page 3 of 12 
08 August 2016 
1.0 
BACKGROUND AND RATIONALE 
 
1.1 
Study Disease 
 
Nephrolithiasis is a relatively common affliction, affecting upwards of 10% of the 
US population and accounts for a significant number of Emergency Department 
(ED) visits [1]. Computed tomography (CT) is the gold standard for evaluation of 
acute renal colic and diagnosis of urolithiasis [2] [3]. Recently, the use of CT has 
come under scrutiny due to ionizing radiation and its attendant risks, including 
skin injury, cataract formation, and most worrisome, solid and hematological 
malignancy [3][4, 5]. Furthermore, radiation exposure is increased in obese 
patients [6], a known risk factor for stone disease. Also, as many patients have a 
life-long affliction with nephrolithiasis[1], the potential for a considerable 
aggregate accumulation of radiation exposure over their lifespan can be excessive 
[5, 7, 8]. This patient population, especially those first diagnosed at a young age, 
would benefit from imaging modalities that do not involve radiation. 
Therefore, various efforts are being made to reduce this radiation exposure. One 
of the most common types of imaging used in the evaluation of nephrolithiasis as 
an alternative to CT is renal and bladder ultrasound (RBUS) [9]. RBUS has 
largely been used as an adjunct study in the management of patients with 
nephrolithiasis[10], especially during pregnancy and in pediatric stone formers. 
Due to its relatively low cost and lack of radiation, it has the potential to have an 
increasingly prominent role. The incorporation of ureteral jets assessment (UJA) 
when using RBUS to assess patients with nephrolithiasis has been shown to have 
added diagnostic and possibly also prognostic value in the evaluation of these 
patients[10]. Several studies have attempted to assess the exact role of UJA in 
patients with nephrolithiasis but have had limited success in delineating its exact 
role in the treatment algorithm [11].  
 
The prognosis of a ureteral stone as can be conveyed to the patient is based on a 
historical study from Miller and Kane. In 1999, the authors studied 75 patients 
with ureteral stones ranging from less than 2mm to 10mm over approximately 6 
weeks’ time. It was found that smaller, more distal stones pass sooner and that 
stones <4mm pass 95% of the time, although this may take up to 40 days [13]. 
Since that time, multiple studies have shown medical expulsive therapy (MET) to 
be effective for earlier stone passage [14, 15, 16]. No modern investigation of 
stone passage rates based on size has been performed in the MET era. 
 
1.2 
Rationale 
 
Due to the increasing use of CT and concern for radiation exposure, it is 
important to consider alternative diagnostic imaging modalities. We seek to 
evaluate patients who present to the Barnes-Jewish Hospital (BJH) ED and to the 
Urology office with renal colic who have been diagnosed with a ureteral stone. 
We seek to determine whether the findings on ureteral jet assessment (UJA) by 
RBUS are predictive of a patient’s clinical outcome. Specifically, we seek to 

Desai 
Urojet study v. 3.0 
Page 4 of 12 
08 August 2016 
evaluate whether the presence, absence or relative strength of the ipsilateral 
ureteral jet can predict spontaneous passage versus need for surgical intervention 
over a 42-day (6-week) time period. As many patients have a life-long affliction 
with nephrolithiasis[1], the potential for a considerable aggregate accumulation of 
radiation exposure over their lifespan can be excessive and should not be 
overlooked [5, 7, 8]. This patient population, especially those first diagnosed at a 
young age, would benefit from imaging modalities that do not involve radiation.  
 
Evaluating the significance of UJA and RBUS in patients with renal colic will help define 
the role of this imaging modality, as an alternative to ionizing radiation-based studies. 
The prognosis of urolithiasis based on UJA will be defined, as well as the natural history 
of stones managed expectantly. We hypothesize that UJA showing weak or absent 
ureteral jet will predict obstruction and a higher rate of surgical treatment compared to 
spontaneous passage. We hypothesize that larger stones will be less likely to pass without 
surgical intervention.   
 
2.0 
OBJECTIVES 
 
2.1 
Primary Objective 
 
1. To determine whether use of renal bladder ultrasound (RBUS) with UJA is predictive 
of spontaneous stone passage versus need for surgical intervention over a 42-day time 
frame.    
 
2.2 
Secondary Objectives 
 
1. To determine whether RBUS with UJA, in conjunction with standard of care history, 
physical examination and laboratory studies confers the same diagnostic information 
as the gold standard, non-contrast CT.  
 
2. To determine the natural history and rate and time of stone passage for ureteral stones 
of differing locations (proximal, mid or distal ureter) and sizes (<2mm, 2-4mm, 5mm, 
6-7mm, 9-10mm). 
 
3.0 
PATIENT SELECTION 
 
3.1 
Inclusion Criteria 
Patients must meet all of the following inclusion criteria to be eligible for study 
participation:  
 
1. Age 18 and older at the time of consent 
2. Willing and able to sign consent 
3. CT diagnosis of ureteral stone with a stone burden less than or equal to 10mm 
 

Desai 
Urojet study v. 3.0 
Page 5 of 12 
08 August 2016 
3.2 
Exclusion Criteria 
Patients must not meet any of the following exclusion criteria to be eligible for study 
participation: 
  
1. Obstructed solitary kidney 
2. Obstructed transplant kidney 
3. Bilateral obstructed kidneys 
4. Any condition or reason that, in the opinion of the treating physician, interferes with 
the patient’s ability to participate or places the patient at undue risk.     
 
3.3 
Inclusion of Women and Minorities 
 
Both men and women and members of all races and ethnic groups are eligible for this 
trial. 
 
4.0 
REGISTRATION PROCEDURES 
 
The following steps must be taken before registering patients to this study: 
 
1. Confirmation of patient eligibility  
2. Assignment of unique patient number (UPN) 
 
4.1 
Assignment of UPN 
 
Once enrolled in the study, each participant will be assigned a unique participant study 
number (study ID) which will not include participant’s initials. Only research team 
members will have access to the master key linking participant number to identifiable 
information, which will remain secure in an encrypted, password-protected file or under 
two locks. Clinical research data will be identified by participant’s unique study number 
and will also include identifiable information such as subject’s name and date of birth. 
Only members of the research team will have access to participants’ research data.  
 
5.0 
STUDY PLAN 
 
5.1 
Screening and Informed Consent 
 
Subjects will be seen and counseled by either the attending ED physician or their 
Urologist as part of the normal course of practice. Patients may be approached about 
study participation as soon as ureteral stone is suspected based on clinical presentation. 
Following CT diagnosis of ureteral stone, study team will further discuss study 
participation with the patient and complete the consent process if the patient is willing to 
participate.   
 
The discussion regarding study participation will take place in a private setting, such as in 
a private consult room, to maintain confidentiality. HRPO approved consent form will be 
used to guide the consent process and document participant’s consent. During the consent 

Desai 
Urojet study v. 3.0 
Page 6 of 12 
08 August 2016 
process, the study team will explain RBUS with UJA, the normal anticipated course of a 
patient with the represented stone burden, potential risks and benefits of study 
participation, compensation and study follow-up schedule. Patients will be encouraged to 
ask questions and discuss the study with family. They will be given ample time to review 
the consent. It is possible that some participants may be contacted by phone to assess 
their interest in this study. If the participant expresses interest in the study, informed 
consent form will be mailed/e-mailed to him/her. This will be done in an effort to allow 
the patient ample time to read the consent at home, consider the study and discuss it with 
friends and family. This will not replace the face-to-face consent discussion the research 
team will have with the patient prior to signing the consent form.  
 
Patients may decline to participate without an impact on their care. They will not be 
pressured to participate. No study related procedures will take place prior to the 
completion of the informed consent process and participant signing the HRPO approved 
consent. 
 
5.2 
Study Plan and Procedures 
 
Study RBUS with UJA will be obtained within 10 days following CT diagnosis of 
ureteral calculus. Ureteral jet data will be documented and patients will be followed 
prospectively for 42 days at 2 weeks, 4 weeks and 42 days (6 weeks) after diagnostic CT. 
Specifically, patients will be followed for spontaneous stone passage and will be 
expected to record date of stone retrieval. If specific date of stone passage is not known, 
date of standard of care imaging confirming absence of stone(s) will be used as the date 
of stone passage. If spontaneous stone passage is not achieved, patients will be counseled 
regarding further standard of care treatment options including surgical stone removal. If 
surgical intervention is indicated, time to surgical procedure will also be recorded. This 
patient cohort will be analyzed retrospectively to determine whether RBUS with UJA is 
predictive of spontaneous stone passage versus need for surgical intervention over a 42-
day period. 
 
Interpretation of RBUS and UJA: 
Abdominal radiologists will interpret the RBUS research reads. All grey scale and color 
Doppler examinations will be performed by means of a commercially available unit with 
a 1-5 MHz phased array transducer or a 1-6 curved transducer. Flow toward the 
transducer is assigned a red color on Doppler. For grey scale evaluation, the presence or 
absence of urinary tract stones, size (longest axis in mm) and location- R, L, upper pole, 
interpolar and lower pole of the kidneys, proximal ureter, distal ureter and bladder- will 
be documented. The level of the renal pelvis represents the interpolar kidney with upper 
and lower pole above and below this level. For this study, a urinary tract stone will be 
termed an echogenic focus that demonstrates either posterior acoustic shadowing and or 
twinkle artifact on color Doppler images. In addition, presence of hydronephrosis (mild, 
moderate, and severe) will be documented. For the purpose of this read, hydronephrosis 
will be defined as such: mild hydronephrosis - urine fills the intra and extra renal pelvis 
and the major calyces are dilated; moderate hydronephrosis – above + dilatation of the 
minor calyx with preservation of the renal parenchyma; severe hydronephrosis – above + 

Desai 
Urojet study v. 3.0 
Page 7 of 12 
08 August 2016 
thin renal parenchyma. In addition, the presence or absence of hydroureter (proximal 
ureter, above the iliac bifurcation and distal ureter, below the iliac bifurcation) will be 
documented. If there is a stone in the renal pelvis, it will be recorded as interpolar kidney 
and noted as renal pelvis. For any case, if the reader believes that a particular stone is the 
cause of the participant’s symptoms, then this will be noted. This is particularly useful in 
cases in which there are multiple stones. The bladder will be examined in the transverse 
plane at the level of the trigone to view both jets simultaneously. All participants will be 
scanned for 5 minutes. The number of jets from each ureteral orifice will be tabulated 
over time so that ureteral jet frequency, defined as number of jets per minute, can be 
calculated. Patients will be categorized into three groups. Group I- no ureteral jets on the 
symptomatic side; Group II- continuous low-level ureteral jet on the symptomatic side; 
Group III– ureteral jets similar to nonsymptomatic side.  
 
In order to determine if RBUS with UJA along with clinical data confers non-inferior 
information compared to non-contrast CT, objective findings such as laboratory data 
including BMP, CBC, urine analysis and physical exam obtained as part of routine care 
will be retrieved from the patient’s medical record and reviewed retrospectively. Clinical 
data and RBUS results will be de-identified/coded and the Urologist will be blinded to 
the CT results. Diagnosis and treatment recommendations will be determined based upon 
these findings and compared to those attained by CT to assess for congruence. Statistical 
analysis will be performed to determine non-inferiority between the studies. 
 
Stone size and location based on CT will be recorded at the time of enrollment into the 
study and time to stone passage will be recorded. All study participants will be followed 
for stone passage. Time to stone passage will be stratified according to stone location 
(proximal, mid or distal ureter) and size (<2mm, 2-4mm, 5mm, 6-7mm, 9-10mm). 
 
5.3 
Study Follow-up 
 
After study RBUS is obtained, patients will be followed prospectively by telephone call 
at 2 weeks, 4 weeks and 42 days (6 weeks) from the time of diagnostic CT. They will be 
followed for spontaneous stone passage, and be asked to keep record of when this occurs. 
During the 42-day follow up, their course will also be monitored for ED visits, surgical 
intervention and hospital admissions. All currently available medical records such as 
Clindesk, Allscripts, Compass, HMED will be reviewed retrospectively to follow 
participants’ clinical course, specifically to determine the need for surgical intervention 
or spontaneous stone passage. Billing records may also be used to identify patients who 
underwent surgical intervention based on CPT codes. Evaluation of the patient’s 
emergency room records with a focus on their presenting symptomatology and initial 
evaluation by the emergency provider will be performed. Any additional laboratory tests 
and/or imaging obtained during their emergency room or office visit will also be 
reviewed and collected for study purposes.    
 
Surgical intervention, including ureteral stent or nephrostomy tube placement, 
ureteroscopy/laser lithotripsy, or extracorporeal shockwave lithotripsy (ESWL) will be 
instituted, as per standard of care. A follow up telephone call at 2 weeks, 4 weeks and 42 

Desai 
Urojet study v. 3.0 
Page 8 of 12 
08 August 2016 
days (6 weeks) from the time of diagnostic CT will be performed in case of care received 
outside of the Barnes-Jewish Hospital (BJH) system and medical records reviewed for 
ER visits, hospital admissions and surgical intervention. 
 
5.4 
Risks and benefits associated with study participation  
 
The results from this study will not directly benefit the patients who agree to participate, 
however, we hope they will help define the role of RBUS with UJA as an alternative to 
ionizing radiation-based studies. Knowledge gained from this study may help us improve 
our stone management practice.     
Participation in this study will not affect the patient’s risks associated with the standard of 
care stone management. There are no risks associated with an abdominal ultrasound. 
Patient may feel slight discomfort if he or she is experiencing abdominal pain.  
Risks associated with the medical expulsive therapy and/or surgical procedure for stone 
management will be discussed with all participants as part of their clinical care and 
clinical consent for the procedure will be obtained.   
5.5 
Duration of Follow-Up 
 
Patients will be followed by telephone call at 2 and 4 weeks and 42 days (6 weeks) after 
diagnostic CT. They will have a clinic visit with their urologist per standard of care practice. 
 
5.6 
Criteria for Removal from Study 
 
If at any time the constraints of this protocol are considered to be detrimental to the 
patient’s health and/or the patient no longer wishes to continue with study participation, 
the patient should be removed from the study and the reason(s) for discontinuation 
documented. 
 
Otherwise, the patient will be followed and evaluated as described. 
 
6.0 
DATA AND SAFETY MONITORING 
 
Participation in the proposed study will not pose any risks to the participants beyond what 
is expected from the standard of care stone management.  
 
 
The PI will monitor the study for any reportable events from the time of the study RBUS 
to day 42 post diagnostic CT. All HRPO guidelines for reporting events meeting defined 
criteria will be followed.  
 
7.0 
STATISTICAL CONSIDERATIONS 
 
7.1 
Study Objectives and Endpoints 
Primary Outcome:  
To determine if RBUS with UJA is prognostic of stone passage versus need for 

Desai 
Urojet study v. 3.0 
Page 9 of 12 
08 August 2016 
surgical intervention: 
1. Passage of stone as assessed by patient self-report and/or collection of stone or 
imaging.  
2. Need for further medical attention as collected by chart review and phone 
interview for ED visit, hospitalization, or need for surgical intervention during the 
42-day follow-up period. 
 
Secondary Outcomes: 
1. To determine if RBUS with UJA, in conjunction with standard of care laboratory 
data and history and physical confers non-inferior information compared to non-
contrasted CT: 
a. Urologist will review the patient’s de-identified/coded history and physical, 
laboratory studies, and RBUS with UJA and make an assessment and 
treatment recommendations. The urologist will be blinded to the results of the 
CT. Comparison will be made between the CT diagnosis and the blinded 
assessment of the urologist. 
 2.   To determine if the natural history and rate and time of stone passage for ureteral 
stones of differing locations (proximal, mid or distal ureter) and sizes (<2mm, 2-
4mm, 5mm, 6-7mm, 9-10mm): 
a. Assessment of the stone location and size to be conducted by a radiologist. 
 
7.2 
Study Design 
This is a single institution, prospective study to evaluate the prognostic significance of 
RBUS with UJA, and its utility in providing non-inferior information compared to non-
contrasted CT, as well as to evaluate the spontaneous stone passage rate of ureteral stones. 
The study will be conducted at Washington University and will enroll approximately 100 
participants over two years. 
7.3 
Data Analysis 
 
Primary objective: 
This patient cohort will be analyzed retrospectively to determine whether US with UJA is 
predictive of spontaneous stone passage versus need for surgical intervention. Kaplan-
Meier curve will be used to test time to spontaneous stone passage between the two groups. 
A chi-square test of independence will be used to test intervention rates between the two 
groups. A multivariate analysis will also be conducted controlling for such variables as 
age, gender, BMI, side, size of stone, and stone passage. A Cox-proportional hazards model 
will be used for time to spontaneous stone passage and logistic regression will be used for 
intervention.   
 
Due to the unforeseen difficulty of recruitment and the uncertain assumptions of the initial 
power analysis, an interim statistical analysis is recommended to be performed when the 
recruitment reaches 50 patients.  Based on the results, a decision will be made whether to 
continue recruitment to the initial 100 targeted patients, adjust the number of targeted 
patients based on a new power analysis, or to discontinue recruitment. The interim results 

Desai 
Urojet study v. 3.0 
Page 10 of 12 
08 August 2016 
should not affect primary independent variables in the study as the radiologist performing 
the ultrasounds will not have access to the results. 
 
Secondary objective 1:  
Statistical analysis will be performed to determine diagnostic and treatment concordance 
between the two methods.  A multivariate logistic regression model will also test patient 
factors that are associated with discordant results. 
 
Secondary objective 2: 
In a prospective manner, they will be followed to determine the natural history of ureteral 
stones with regard to stone passage. Average time to stone passage for each size category 
and stone location will be determined. Cox-proportional hazard models will be used to 
determine significant factors affecting time to stone passage. 
  
 
 
 

Desai 
Urojet study v. 3.0 
Page 11 of 12 
08 August 2016 
 
8.0 
REFERENCES 
 
1.  
Scales, C., et al., Prevalence of kidney stones in the United States. European urology, 
2012. 
2. 
Türk, C., et al., Guidelines on urolithiasis. European Association of Urology, 2011. 
3. 
Kim, B.S., et al., Low-Dose and Standard-Dose Unenhanced Helical Computed 
Tomography for the Assessment of Acute Renal Colic: Prospective Comparative Study. 
Acta Radiologica, 2005. 46(7): p. 756-763. 
4. 
Mancini, J.G. and M.N. Ferrandino, The impact of new methods of imaging on radiation 
dosage delivered to patients. Curr Opin Urol, 2010. 20(2): p. 163-8. 
5. 
Smith-Bindman, R., et al., Radiation dose associated with common computed 
tomography examinations and the associated lifetime attributable risk of cancer. 
Archives of Internal Medicine, 2009. 169(22): p. 2078. 
6. 
Wang, A.J., et al., Obesity triples the radiation dose of stone protocol computerized 
tomography. J Urol, 2013. 189(6): p. 2142-6. 
7. 
Sodickson, A., et al., Recurrent CT, cumulative radiation exposure, and associated 
radiation-induced cancer risks from CT of adults. Radiology, 2009. 251(1): p. 175-184. 
8. 
Broder, J., et al., Cumulative CT exposures in emergency department patients evaluated 
for suspected renal colic. The Journal of emergency medicine, 2007. 33(2): p. 161-168. 
9. 
Passerotti, C., et al., Ultrasound versus computerized tomography for evaluating 
urolithiasis. The Journal of urology, 2009. 182(4): p. 1829-1834. 
10. 
Sheafor, D.H., et al., Nonenhanced Helical CT and US in the Emergency Evaluation of 
Patients with Renal Colic: Prospective Comparison1. Radiology, 2000. 217(3): p. 792-
797. 
11. 
Burge, H., et al., Ureteral jets in healthy subjects and in patients with unilateral ureteral 
calculi: comparison with color Doppler US. Radiology, 1991. 180(2): p. 437-442. 

Desai 
Urojet study v. 3.0 
Page 12 of 12 
08 August 2016 
APPENDIX A: Study Schedule of Events 
 
 
 
 
1 as part of standard clinical care. 
 
 
 
 
 
 
 
 
 
Post-Enrollment Assessment and Follow-up 
 
Within one 
day of 
diagnostic 
CT 
 
2 weeks post 
diagnostic CT 
(+/- 2 days) 
 
4 weeks 
post 
diagnostic 
CT (+/- 2 
days) 
 
42 days (6 
weeks) post 
diagnostic 
CT (+ 3 
days) 
Informed Consent 
X 
 
 
 
Incl./Excl. Criteria Confirmation 
X 
 
 
 
RBUS with UJA 
X 
 
 
 
Demographics1 
X 
 
 
 
Medical & Surgical History1 
X 
 
 
 
Height & Weight1 
X 
 
 
 
Basic metabolic panel1 
X 
 
 
 
Complete blood count1 
X 
 
 
 
Urine analysis and microscopy1 
X 
 
 
 
CT scan1 
X 
 
 
 
 
 
 
 
 
Assessments: 
 
 
 
 
Study related AEs/reportable events 
 
X 
X 
X 
Clinical stone management1 
 
X 
X 
X 
Passage of stone 
 
X 
X 
X