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

NCT02577146 | Completed Results

• 1 other identifier: 201506127
• Study Type: interventional
• Target: 74
• Locations: 1 country
• Sites: 1

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.

Conditions

Ureteral Calculi

Keywords

stone; ureter; ultrasound

Outcome Measures

Primary Outcomes (1)

• 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).

  42 days

Secondary Outcomes (1)

• The Number of Cases With Concordant Treatment Recommendations Based on the Ultrasound and CT Scan.

  42 days

Study Arms (1)

Study ultrasound

EXPERIMENTAL

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

Interventions

renal and bladder ultrasound with ureteral jet assessment DEVICE

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.

Study ultrasound

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Washington University School of Medicine: lead
• Midwest Stone Institute.: collaborator

Study Sites (1)

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

MeSH Terms

Conditions

Ureteral Calculi; Calculi

Condition Hierarchy (Ancestors)

Ureterolithiasis; Ureteral Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urolithiasis; Urinary Calculi; Male Urogenital Diseases; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Alana Desai, M.D.
• Organization: Washington University School of Medicine

desaia@wustl.edu

(314) 362-7581

Study Officials

• Alana Desai, M.D.

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 29, 2015
• First Posted: October 16, 2015
• Study Start: October 1, 2015
• Primary Completion: May 7, 2018
• Study Completion: December 1, 2019
• Last Updated: December 10, 2019
• Results First Posted: May 31, 2019

Record last verified: 2019-12

Locations

US (1)