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Tamsulosin for Urolithiasis in the Emergency Dept (STONE)

Primary Purpose

Ureterolithiases

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
tamsulosin
Placebo
Sponsored by
Andrew Meltzer
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ureterolithiases focused on measuring urolithiasis, renal colic, kidney stones, urinary stone disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Age ≥ 18 years
  2. Evidence of ureterolithiasis (i.e. stone is located in ureter, not in bladder) as demonstrated on radiographic studies, specifically non-contrast spiral CT.
  3. Willingness to participate and able to proceed with standard outpatient management (no personal or job-related issues, e.g. airline pilot.
  4. Has a telephone in order to be contacted for follow-up.

Exclusion Criteria:

  1. Patient desiring or requiring immediate surgical intervention making then not a candidate for outpatient kidney stone management.
  2. Current urinary tract infection based on urine dipstick as admission and urgent procedural management are likely indicated.
  3. Known anatomical genitourinary abnormalities or prior Genitourinary surgeries.
  4. Positive pregnancy test making proper radiological imaging contraindicated.
  5. Breastfeeding mothers.
  6. History of hypersensitivity to tamsulosin.
  7. Current use of alpha blockers or calcium channel blockers.
  8. Current use of steroids which may have an independent effect on stone expulsion.
  9. Spontaneous stone expulsion prior to enrollment.
  10. Largest stone dimension ≥ 9mm assessed using radiologic imaging, being very unlikely to pass spontaneously.
  11. Presence of stone in the bladder.
  12. Current use of vardenafil which is tamsulosin contraindicated.
  13. Ipsilateral, transplanted or solitary kidney as hospitalization may be necessary.
  14. Known renal insufficiency.
  15. Fever defined as >101.5°F which may indicate infection.
  16. Floppy iris syndrome which is tamsulosin contraindicated.
  17. Planned cataract surgery in the next 60 days which is tamsulosin contraindicated.
  18. Prisoners /wards of state.
  19. Prior enrollment in STONE (Candidates who are screened and found ineligible may be rescreened at a later date.)

Sites / Locations

  • University of Alabama - Birmingham
  • The George Washington University Medical Center
  • Thomas Jefferson University
  • University of Pittsburgh

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Tamsulosin

Placebo

Arm Description

Tamsulosin 0.4mg PO qd for 28 days

Placebo PO qd for 28 days

Outcomes

Primary Outcome Measures

Proportion of Patients Passing Their Stone Within 28 Days by Self Report
Hypothesis: The administration of tamsulosin after the clinical and radiographic diagnosis of acute urolithiasis will produce an increase in the proportion of patients passing their stone within 28 days.

Secondary Outcome Measures

Any Pain Medication
Patients on any pain medication at day 28
Need for Surgical Intervention
Crossover to Open Label Tamsulosin
Confirmation of Stone Passage on CT
Return to Work (if Employed)

Full Information

First Posted
September 28, 2006
Last Updated
November 13, 2018
Sponsor
Andrew Meltzer
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
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1. Study Identification

Unique Protocol Identification Number
NCT00382265
Brief Title
Tamsulosin for Urolithiasis in the Emergency Dept
Acronym
STONE
Official Title
Study of Tamsulosin for Urolithiasis in the Emergency Department
Study Type
Interventional

2. Study Status

Record Verification Date
November 2018
Overall Recruitment Status
Completed
Study Start Date
January 2008 (undefined)
Primary Completion Date
February 1, 2017 (Actual)
Study Completion Date
February 1, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Andrew Meltzer
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Urolithiasis is a disease that effects 12% of the population and its incidence is growing. In the US there are over 1.1 million visits annually to Emergency Departments for renal colic. The disease is extremely painful, often requiring large amounts of narcotic analgesia, and results in lost work days. Moreover, up to 30% of patients may eventually require lithotripsy or surgical removal of the stone. Currently there are no medical interventions other than analgesia which are offered to patients. Based on encouraging results from several small European clinical studies, the researchers hypothesize that the administration of tamsulosin to patients with symptomatic urolithiasis will enhance stone passage, and reduce both the time to recovery and the need for surgical intervention or lithotripsy. The researchers will conduct a study by identifying and recruiting patients presenting with urolithiasis in the emergency departments of four institutions. A total of 500 consenting subjects will be randomly assigned to one of two groups: tamsulosin for a maximum of 28 days; placebo for a maximum of 28 days. In addition, both groups will receive standard analgesic therapy. The study team, which will be blinded to treatment status, will monitor each subject's clinical progress and outcome. The primary objectives of this study are: to determine if tamsulosin is effective, and to evaluate the safety of the therapy. Another objective is to identify the most appropriate clinical subgroup(s) for treatment. If the therapeutic benefits observed in smaller clinical studies are replicated, administration of these medications should produce several benefits, including: a reduction in time to pain free recovery and hence a more rapid return to employment; decreased requirements for narcotic analgesia; less need for urological out-patient clinic follow-up; decreased need for surgical intervention or lithotripsy; and substantial cost savings. If this therapy is beneficial, it will represent a major advance in the treatment of urolithiasis. This objective is a major stated goal of the NIDDK (National Institute of Diabetes and Digestive and Kidney Diseases) Clinical Urology Program, which has a stated mission to improve the treatment of urolithiasis. Kidney stones are a major public health issue, and one person in eight will be affected by the disease. If the hypothesis is verified, the researchers will provide the first medical therapy ever for this disease. This therapy, if effective, will reduce the amount of time a patient is off work because of the pain from the disease, and may also reduce the need for expensive and time-consuming surgical treatments.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ureterolithiases
Keywords
urolithiasis, renal colic, kidney stones, urinary stone disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
512 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Tamsulosin
Arm Type
Active Comparator
Arm Description
Tamsulosin 0.4mg PO qd for 28 days
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo PO qd for 28 days
Intervention Type
Drug
Intervention Name(s)
tamsulosin
Intervention Description
tamsulosin 0.4mg po qd for 28 days
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
placebo po qd for 28 days
Primary Outcome Measure Information:
Title
Proportion of Patients Passing Their Stone Within 28 Days by Self Report
Description
Hypothesis: The administration of tamsulosin after the clinical and radiographic diagnosis of acute urolithiasis will produce an increase in the proportion of patients passing their stone within 28 days.
Time Frame
28 days
Secondary Outcome Measure Information:
Title
Any Pain Medication
Description
Patients on any pain medication at day 28
Time Frame
28 days
Title
Need for Surgical Intervention
Time Frame
28 days
Title
Crossover to Open Label Tamsulosin
Time Frame
28 days
Title
Confirmation of Stone Passage on CT
Time Frame
28 days
Title
Return to Work (if Employed)
Time Frame
28 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age ≥ 18 years Evidence of ureterolithiasis (i.e. stone is located in ureter, not in bladder) as demonstrated on radiographic studies, specifically non-contrast spiral CT. Willingness to participate and able to proceed with standard outpatient management (no personal or job-related issues, e.g. airline pilot. Has a telephone in order to be contacted for follow-up. Exclusion Criteria: Patient desiring or requiring immediate surgical intervention making then not a candidate for outpatient kidney stone management. Current urinary tract infection based on urine dipstick as admission and urgent procedural management are likely indicated. Known anatomical genitourinary abnormalities or prior Genitourinary surgeries. Positive pregnancy test making proper radiological imaging contraindicated. Breastfeeding mothers. History of hypersensitivity to tamsulosin. Current use of alpha blockers or calcium channel blockers. Current use of steroids which may have an independent effect on stone expulsion. Spontaneous stone expulsion prior to enrollment. Largest stone dimension ≥ 9mm assessed using radiologic imaging, being very unlikely to pass spontaneously. Presence of stone in the bladder. Current use of vardenafil which is tamsulosin contraindicated. Ipsilateral, transplanted or solitary kidney as hospitalization may be necessary. Known renal insufficiency. Fever defined as >101.5°F which may indicate infection. Floppy iris syndrome which is tamsulosin contraindicated. Planned cataract surgery in the next 60 days which is tamsulosin contraindicated. Prisoners /wards of state. Prior enrollment in STONE (Candidates who are screened and found ineligible may be rescreened at a later date.)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andrew C Meltzer, MD
Organizational Affiliation
The George Washington University
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Alabama - Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35249
Country
United States
Facility Name
The George Washington University Medical Center
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20037
Country
United States
Facility Name
Thomas Jefferson University
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Facility Name
University of Pittsburgh
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15261
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
33213185
Citation
Meltzer AC, Wolfson AB, Mufarrij P, MacPherson C, Montano N, Kirkali Z, Burrows PK, Jackman SV. Analgesic and Opioid Use for Patients Discharged from the Emergency Department with Ureteral Stones. J Endourol. 2021 Jul;35(7):1067-1071. doi: 10.1089/end.2020.0835. Epub 2021 Jan 21.
Results Reference
derived
PubMed Identifier
29913020
Citation
Meltzer AC, Burrows PK, Wolfson AB, Hollander JE, Kurz M, Kirkali Z, Kusek JW, Mufarrij P, Jackman SV, Brown J. Effect of Tamsulosin on Passage of Symptomatic Ureteral Stones: A Randomized Clinical Trial. JAMA Intern Med. 2018 Aug 1;178(8):1051-1057. doi: 10.1001/jamainternmed.2018.2259.
Results Reference
derived
PubMed Identifier
27890522
Citation
Burrows PK, Hollander JE, Wolfson AB, Kurz MC, Richards L, DiFiore S, Watts P, Patkar N, Brown J, Jackman S, Kirkali Z, Kusek JW, Michel C, Meltzer AC; STONE Study Investigators. Design and challenges of a randomized clinical trial of medical expulsive therapy (tamsulosin) for urolithiasis in the emergency department. Contemp Clin Trials. 2017 Jan;52:91-94. doi: 10.1016/j.cct.2016.11.010. Epub 2016 Nov 23.
Results Reference
derived

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Tamsulosin for Urolithiasis in the Emergency Dept

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