Trial Outcomes & Findings for The Predictive Value of Ureteral Jet Assessment With Ultrasound in Patients Presenting With Acute Renal Colic (NCT NCT02577146)

Results Overview

Number of days that have elapsed from date of diagnosis to date of stone passage or intervention to maximum observation time (42 days).

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

74 participants

Primary outcome timeframe

42 days

Results posted on

2019-12-10

Participant milestones
Measure	Study Ultrasound Study ultrasound with ureteral jet assessment will be obtained after CT diagnosis of ureteral calculus is made. Ureteral jet data will be documented and patients will be followed prospectively for 42 days for spontaneous stone passage or need for surgical intervention. renal and bladder ultrasound with ureteral jet assessment: 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.
Overall Study STARTED	74
Overall Study COMPLETED	46
Overall Study NOT COMPLETED	28

Reasons for withdrawal
Measure	Study Ultrasound Study ultrasound with ureteral jet assessment will be obtained after CT diagnosis of ureteral calculus is made. Ureteral jet data will be documented and patients will be followed prospectively for 42 days for spontaneous stone passage or need for surgical intervention. renal and bladder ultrasound with ureteral jet assessment: 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.
Overall Study Lost to Follow-up	8
Overall Study Physician Decision	3
Overall Study Screen Failure	17

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort
Measure	Study Ultrasound n=46 Participants Study ultrasound with ureteral jet assessment will be obtained after CT diagnosis of ureteral calculus is made. Ureteral jet data will be documented and patients will be followed prospectively for 42 days for spontaneous stone passage or need for surgical intervention. renal and bladder ultrasound with ureteral jet assessment: 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.
Age, Categorical <=18 years	0 Participants n=46 Participants
Age, Categorical Between 18 and 65 years	43 Participants n=46 Participants
Age, Categorical >=65 years	3 Participants n=46 Participants
Age, Continuous	45.1 years STANDARD_DEVIATION 13.9 • n=46 Participants
Sex: Female, Male Female	16 Participants n=46 Participants
Sex: Female, Male Male	30 Participants n=46 Participants
Region of Enrollment United States	46 Participants n=46 Participants

Timeframe: 42 days

Population: 28 cases were not included in analysis due to screen failures, subject non-compliance and missing data.

Number of days that have elapsed from date of diagnosis to date of stone passage or intervention to maximum observation time (42 days).

Outcome measures
Measure	Study Ultrasound n=46 Participants Study ultrasound with ureteral jet assessment will be obtained after CT diagnosis of ureteral calculus is made. Ureteral jet data will be documented and patients will be followed prospectively for 42 days for spontaneous stone passage or need for surgical intervention. renal and bladder ultrasound with ureteral jet assessment: 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.
Time in Days From Diagnosis to Stone Passage. Present Jets	5 Days Interval 3.0 to 13.0
Time in Days From Diagnosis to Stone Passage. Absent Jets	13 Days Interval 8.0 to Sample size is too small to estimate upper limit of 95% confidence interval.

Timeframe: 42 days

Population: 28 cases were not included in analysis due to screen failures, subject non-compliance and missing data.

Outcome measures
Measure	Study Ultrasound n=46 Participants Study ultrasound with ureteral jet assessment will be obtained after CT diagnosis of ureteral calculus is made. Ureteral jet data will be documented and patients will be followed prospectively for 42 days for spontaneous stone passage or need for surgical intervention. renal and bladder ultrasound with ureteral jet assessment: 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.
The Number of Cases With Concordant Treatment Recommendations Based on the Ultrasound and CT Scan.	29 Cases

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Adverse event data not reported

Adverse event data not reported

Washington University School of Medicine

Phone: (314) 362-7581