The Predictive Value of Ureteral Jet Assessment With Ultrasound in Patients Presenting With Acute Renal Colic

• Sponsor: Washington University School of Medicine (Other)
• Overall Status: Completed
• CT.gov ID: NCT02577146
• Collaborator: Midwest Stone Institute. (Other)
• Enrollment: 74
• Location: 1
• Arm: 1
• Duration (Months): 50
• Patients Per Site Per Month: 1.5

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Ureteral Calculi	Device: renal and bladder ultrasound with ureteral jet assessment	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 74 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Diagnostic
• Official Title: The Predictive Value of Ureteral Jet Assessment With Ultrasound in Patients Presenting With Acute Renal Colic
• Study Start Date: Oct 1, 2015
• Actual Primary Completion Date: May 7, 2018
• Actual Study Completion Date: Dec 1, 2019

Arms and Interventions

Arm

Intervention/Treatment

Experimental: 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.

Device: 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.

Outcome Measures

Primary Outcome Measures

1. 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 Outcome Measures

1. The Number of Cases With Concordant Treatment Recommendations Based on the Ultrasound and CT Scan. [42 days]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Washington University School of Medicine	Saint Louis	Missouri	United States	63110

Sponsors and Collaborators

• Washington University School of Medicine
• Midwest Stone Institute.

Investigators

• Principal Investigator: Alana Desai, M.D., Washington University School of Medicine

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Aug 8, 2016

More Information

Publications

None provided.

• Responsible Party: Washington University School of Medicine
• ClinicalTrials.gov Identifier: NCT02577146
• Other Study ID Numbers: 201506127
• First Posted: Oct 16, 2015
• Last Update Posted: Dec 10, 2019
• Last Verified: Dec 1, 2019

• Keywords provided by Washington University School of Medicine: stone; ureter; ultrasound
• Additional relevant MeSH terms: Ureteral Calculi; Ureterolithiasis; Calculi; Renal Colic

Study Results

Participant Flow

Arm/Group Title	Study Ultrasound
Arm/Group Description	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.
Period Title: Overall Study
STARTED	74
COMPLETED	46
NOT COMPLETED	28

Baseline Characteristics

Arm/Group Title	Study Ultrasound
Arm/Group Description	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 Participants	46
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	43 93.5%
>=65 years	3 6.5%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	45.1 (13.9)
Sex: Female, Male (Count of Participants)
Female	16 34.8%
Male	30 65.2%
Race and Ethnicity Not Collected (Count of Participants)
Region of Enrollment (Count of Participants)
United States	46 100%

Outcome Measures

1. Primary Outcome

Title	Time in Days From Diagnosis to Stone Passage.
Description	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

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Study Ultrasound
Arm/Group Description	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.
Measure Participants	46
Present Jets	5
Absent Jets	13

2. Secondary Outcome

Title	The Number of Cases With Concordant Treatment Recommendations Based on the Ultrasound and CT Scan.
Time Frame	42 days

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Study Ultrasound
Arm/Group Description	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.
Measure Participants	46
Number [Cases]	29

Adverse Events

Time Frame	Participation in the proposed study did not pose any risks to the participants beyond what was expected from the standard of care stone management. Study PI monitored the study for any adverse events from the time of the study RBUS to day 42 post diagnostic CT. The timeframe in which data for adverse events was collected for this study was up to 45 days.
Arm/Group Title	Study Ultrasound
Arm/Group Description	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.
All Cause Mortality
	Study Ultrasound
	Affected / at Risk (%)	# Events
Total	0/46 (0%)
Serious Adverse Events
	Study Ultrasound
	Affected / at Risk (%)	# Events
Total	0/46 (0%)
Other (Not Including Serious) Adverse Events
	Study Ultrasound
	Affected / at Risk (%)	# Events
Total	0/46 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.