Ureteral Calculi
Conditions
Keywords
stone, ureter, ultrasound
Brief summary
This is a single institution, prospective study to evaluate the prognostic significance of renal and bladder ultrasound with ureteral jet assessment and its utility to evaluate the spontaneous stone passage rate of ureteral stones.
Interventions
DEVICErenal 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.
Sponsors
Midwest Stone Institute.
Washington University School of Medicine
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* age 18 and older at the time of consent * willing and able to sign consent * CT diagnosis of ureteral stone with a stone burden less than or equal to 10mm
Exclusion criteria
* obstructed solitary kidney * obstructed transplant kidney * bilateral obstructed kidneys * 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time in Days From Diagnosis to Stone Passage. | 42 days | Number of days that have elapsed from date of diagnosis to date of stone passage or intervention to maximum observation time (42 days). |
Secondary
| Measure | Time frame |
|---|---|
| The Number of Cases With Concordant Treatment Recommendations Based on the Ultrasound and CT Scan. | 42 days |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 46 |
| Total | 46 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lost to Follow-up | 8 |
| Overall Study | Physician Decision | 3 |
| Overall Study | Screen Failure | 17 |
Baseline characteristics
| Characteristic | Study Ultrasound | — |
|---|---|---|
| Age, Categorical <=18 years | 0 Participants | — |
| Age, Categorical >=65 years | 3 Participants | — |
| Age, Categorical Between 18 and 65 years | 43 Participants | — |
| Age, Continuous | 45.1 years STANDARD_DEVIATION 13.9 | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment United States | 46 Participants | — |
| Sex: Female, Male Female | 16 Participants | — |
| Sex: Female, Male Male | 30 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 46 |
| other Total, other adverse events | 0 / 46 |
| serious Total, serious adverse events | 0 / 46 |
Outcome results
Primary
Time in Days From Diagnosis to Stone Passage.
Number of days that have elapsed from date of diagnosis to date of stone passage or intervention to maximum observation time (42 days).
Time frame: 42 days
Population: 28 cases were not included in analysis due to screen failures, subject non-compliance and missing data.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Study Ultrasound | Time in Days From Diagnosis to Stone Passage. | Present Jets | 5 Days |
| Study Ultrasound | Time in Days From Diagnosis to Stone Passage. | Absent Jets | 13 Days |
Secondary
The Number of Cases With Concordant Treatment Recommendations Based on the Ultrasound and CT Scan.
Time frame: 42 days
Population: 28 cases were not included in analysis due to screen failures, subject non-compliance and missing data.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Study Ultrasound | The Number of Cases With Concordant Treatment Recommendations Based on the Ultrasound and CT Scan. | 29 Cases |